Description:
Biofeedback is a technique to teach patients self-regulation of physiologic processes not generally considered to be under voluntary control; a variety of approaches and devices are available. Biofeedback, in conjunction with pelvic floor muscle training (PFMT), is proposed as a treatment of urinary incontinence.

Summary of Evidence
For individuals who have urinary incontinence (women) who receive biofeedback with PFMT, the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, functional outcomes, and quality of life. A comparative effectiveness review did not find a statistically significant difference in continence rates when patients received PFMT with or without biofeedback. Other systematic reviews evaluating biofeedback and/or verbal feedback as part of treatment for urinary incontinence found improvement in some outcomes but not others. There is a lack of consistent evidence from well-designed trials that biofeedback effectively treats urinary incontinence. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have post-prostatectomy urinary incontinence, the evidence includes an RCT and systematic reviews that compared PFMT with or without biofeedback. Relevant outcomes are symptoms, functional outcomes, and quality of life. Results of these data were mixed, and did not consistently report significantly improved outcomes when biofeedback was added to the intervention. The timing and delivery of the intervention were not well-defined. Additional well-designed trials are needed that demonstrate the superiority of biofeedback with PFMT over PFMT alone. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who will undergo radical prostatectomy, RCTs have evaluated the efficacy of biofeedback with PFMT compared with PFMT without biofeedback for prevention of prostatectomy-related urinary incontinence. These trials generally did not report improved outcomes with biofeedback added to the intervention. The timing and delivery of the intervention were not well-defined. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Additional Information
Not applicable.

Background
Biofeedback
Biofeedback is intended to teach patients self-regulation of certain physiologic processes not normally considered to be under voluntary control. The technique involves feedback on a variety of types of information not commonly available to the patient, followed by a concerted effort on the part of the patient to use this feedback to help alter the physiologic process in some specific way. Biofeedback has been proposed as a treatment for a variety of diseases and disorders, including anxiety, headaches, hypertension, movement disorders, incontinence, pain, asthma, Raynaud disease, and insomnia. Biofeedback training is done either in individual or group sessions and as a single therapy or in combination with other therapies designed to teach relaxation. A typical program consists of 10 to 20 training sessions of 30 minutes each. Training sessions are performed in a quiet, nonarousing environment. Subjects are instructed to use mental techniques to affect the physiologic variable monitored, and feedback is provided for the successful alteration of the physiologic parameter. This feedback may be in the form of signals, such as lights or tone, verbal praise, or other auditory or visual stimuli.

Biofeedback, in conjunction with pelvic floor muscle training, is a possible treatment modality for stress, urge, mixed, and overflow urinary incontinence because it may enhance awareness of body functions and the learning of exercises to train pelvic muscles. Several proposed biofeedback methods that may be employed to treat urinary incontinence, including vaginal cones or weights, perineometers, and electromyographic systems with vaginal and rectal sensors.

The various forms of biofeedback mainly differ in the nature of the disease or disorder under treatment, the biologic variable that the subject attempts to control, and the information that is fed back to the subject. Biofeedback techniques include peripheral skin temperature feedback, blood-volume-pulse feedback (vasoconstriction and dilation), vasoconstriction training (temporalis artery), and electromyographic biofeedback; they may be used alone or in conjunction with other therapies (e.g., relaxation, behavioral management, medication). 

Regulatory Status
A variety of biofeedback devices are cleared for marketing though the U.S. Food and Drug Administration’s (FDA) 510(k) process. The FDA defines a biofeedback device as "an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters."

Related Policies
10117 Pelvic Floor Stimulation as a Treatment of Urinary Incontinence
70119 Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence
70169 Sacral Nerve Neuromodulation/Stimulation
701106 Posterior Tibial Nerve Stimulation for Voiding Dysfunction

Policy:
Biofeedback is investigational and/ or unproven and is therefore considered NOT MEDICALLY NECESSARY as a treatment of urinary incontinence in adults.

Unsupervised home use of biofeedback for treatment of urinary incontinence is investigational and/ or unproven and is therefore considered NOT MEDICALLY NECESSARY.

Policy Guidelines
Coding
Please see the Codes table for details.

Benefit Application
Blue Card/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and, thus, these devices may be assessed only on the basis of their medical necessity.

Biofeedback and biofeedback devices are specifically excluded under many benefit plans. In addition, biofeedback and biofeedback devices are considered behavioral training and education/training in nature, and such services are also specifically excluded under many benefit plans.

Rationale 
This evidence review was created in July 1997 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through June 20, 2022.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Several methodologic difficulties arise in assessing biofeedback.¹ Most interventions that include biofeedback are multimodal and include relaxation and behavioral instruction, which may have effects separate from those due to biofeedback. While studies may report a beneficial effect of multimodality treatment, without appropriate control conditions, it is impossible to isolate the specific contribution of biofeedback to the overall treatment effect. For example, relaxation, attention, or suggestion may account for successful results that have been attributed to biofeedback. These effects are nonspecific therapeutic factors, some of which can be considered placebo effects. To demonstrate the efficacy of biofeedback for treating incontinence, studies are needed to isolate the effect of biofeedback and demonstrate an improvement in health outcomes compared with other interventions (e.g., relaxation or behavioral therapy alone). In addition, although research has shown that feedback on physiologic processes has enhanced patients' ability to control these processes, the evidence is needed on the relationship between a patient's ability to exert control over the targeted physiologic process and any health benefits of the intervention. The latter finding underscores the importance of seeking controlled studies showing whether the use of biofeedback improves disease-related health outcomes, as opposed to physiologic, intermediate outcomes.

Women With Urinary Incontinence
Clinical Context and Therapy Purpose
The purpose of biofeedback with pelvic floor muscle training (PFMT) in women who have urinary incontinence is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of biofeedback with PFMT improve the net health outcome in women with urinary incontinence?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is women with urinary incontinence.

Urinary incontinence is a common condition defined as involuntary leakage of urine. Women are twice as likely to be affected as men, and prevalence increases with age. The severity of incontinence affects the quality of life and treatment decisions. The types of urinary incontinence women may experience include stress, urge, overflow, and functional. Nonsurgical treatment options may include pharmacologic treatment, pelvic muscle exercises, bladder training exercises, electrical stimulation, and neuromodulation.

Interventions
The therapy being considered is biofeedback with PFMT.

Comparators
The following therapy is currently being used to make decisions about urinary incontinence: PFMT without biofeedback.

Outcomes
The general outcomes of interest are symptom improvement (e.g., incontinence episodes) and functional improvement (generally 1 to 4 treatments per week, for 8 to 12 weeks).²

Table 1. Outcomes Measures for Women With Urinary Incontinence

Measure	Outcome Evaluated	Description	Follow-up Timing
Oxford Grading Scale Pelvic Floor Muscle Function	Functional improvement	Used by physiotherapists to assess muscle strength as graded 0 to 5.3 0 = no movement 1 = flicker of movement 2 = through full range actively with gravity counterbalanced 3 = through full range actively against gravity 4 = through full range actively against some resistance 5 = through full range actively against strong resistance	Baseline and at end of therapy (8 to 12 weeks)
PERFECT Scheme	Functional improvement	A way of measuring pelvic muscle function and strength. PERFECT stands for4 Power (Modified Oxford Scale) Endurance (how long contraction is held, up to 10 s) Repetitions (up to 10 repetitions of a 10-s hold) Fast (number of 1-s contractions in a row, up to 10) Every Contraction Timed (reminder to time every contraction)	Baseline and at end of therapy (8 to 12 weeks)

s: second(s)

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
Zhu et al. (2022) performed a meta-analysis of 17 RCTs in postpartum women with lower urinary tract symptoms.⁵ Fifteen studies (N = 1965) compared PFMT plus biofeedback and electrical stimulation with PFMT alone. The analysis reported a significantly greater likelihood of achieving a therapeutic effect with combined PFMT plus biofeedback and electrical stimulation versus PFMT alone (risk ratio, 1.20; 95% confidence interval [CI], 1.15 to 1.24; I2 = 0%). Pelvic floor muscle strength was also significantly higher with combination therapy (p < .0001), but there was high heterogeneity among studies for this outcome (I2 = 66%). Limitations of this analysis include that 6 studies had a high risk of bias, no studies were blinded, there was evidence of publication bias, most studies were conducted in China, and the study's definition of therapeutic effect was not clearly stated.

Wu et al. (2021) conducted a meta-analysis (N = 21 studies; 13 RCTs, 8 nonrandomized) of PFMT with electromyographic biofeedback versus PFMT alone in women with stress incontinence or pelvic floor dysfunction.⁶ Most studies were conducted in China and none were from the U.S. In an analysis of studies that reported cure and improvement, there was a significant benefit of PFMT with electromyographic biofeedback compared to PFMT alone in patients with both urinary incontinence (odds ratio, 4.82; 95% CI, 2.21 to 10.51; I2 = 85.3%; n = 11 studies) and pelvic floor dysfunction (odds ratio, 2.81; 95% CI, 2.04 to 3.86; I2 = 13.1%; n = 6 studies). Analyses of quality of life and quality of sexual life results were limited by substantial heterogeneity ( > 80%). Limitations of this analysis include an unclear, moderate, or high risk of bias in all studies and use of Kegel exercises only in some studies rather than a complete PFMT program.

In their systematic review, Mateus-Vasconcelos et al. (2018) assessed various physiotherapy methods to strengthen the pelvic floor muscles for women with stress urinary incontinence.⁷ Their review included a mix of RCTs, quasi-experimental trials, and systematic reviews — a total of 6 studies. Only 1 study (an uncontrolled RCT) included biofeedback as a comparator. That study (Pinheiro et al. [2012]) compared the effectiveness of PFMT with biofeedback (group n = 6) to PFMT with palpation (group n = 5). The exercises for the biofeedback group consisted of achieving the same number of rapid and slow contractions of the same duration as that achieved during the PERFECT scheme (8 series).⁸ The palpation group strengthened the pelvic floor muscles while a physiotherapist performed palpations on the central perineal tendon and vagina (4 sessions). At the end of treatment, there was no statistical difference in improvement between the biofeedback group and the palpation group in power, endurance, or rapidity of contractions. This RCT was limited in its small sample size and lack of control group and masking of assessors.

Moroni et al. (2016) published a systematic review of 37 RCTs evaluating conservative treatment of stress urinary incontinence in women.⁹ Five trials ( n = 250 women) were identified that compared PFMT plus biofeedback with biofeedback alone. A pooled analysis of 4 studies found significantly more urine loss as measured by a posttreatment pad test with PFMT alone than with PFMT plus biofeedback (mean difference, 0.90; 95% CI , 0.71 to 1.10). Reviewers noted that the difference between groups was likely not clinically significant because there was only about a 1-gram difference. Moreover, the finding was largely due to the effect of a single study. Results on other outcomes (e.g., quality of life, number of incontinence episodes) could not be pooled due to the imprecision of the estimates.

In an Agency for Healthcare Research and Quality comparative effectiveness review, Shamliyan et al. (2012) identified 6 RCTs (N = 542 patients) comparing PFMT plus biofeedback with PFMT alone.¹⁰ A meta-analysis of these studies did not find a statistically significant difference between interventions in incontinence rates. When the findings were pooled, the relative risk was 1.27 (95% CI, 0.88 to 1.85). The absolute risk difference was 0.08 (95% CI, -0.03 to 0.19).

In a Cochrane systematic review, Herderschee et al. (2011) assessed RCTs on feedback or biofeedback in conjunction with PFMT for treating urinary incontinence in women.¹¹ Feedback was defined as verbal feedback by a clinician, whereas biofeedback involved use of an instrument or device. After examining 36 full-text articles, 24 trials met reviewers' eligibility criteria, and 17 contributed data to the analysis of at least 1 primary outcome measure. Sixteen of the 24 trials compared PFMT plus biofeedback with PFMT alone; 9 of them included the same PFMT programs in both groups. The primary outcomes of the review were quality of life and improvement or cure. Nine trials used one of several validated quality of life instruments; however, only 4 of them reported data in a form amenable to meta-analysis. Thus, the quality of life results were not pooled. Data were pooled for the other primary outcome (improvement or cure) but there was a sufficient number of studies only for comparing PFMT with and without biofeedback. In a pooled analysis of 7 studies, there was a significant reduction in the proportion of women reporting "no improvement or cure" when biofeedback was added to muscle exercise (relative risk, 0.75; 95% CI, 0.66 to 0.86). Reviewers noted there may have been other differences between groups, such as more frequent contact with a health care professional or a greater number of treatment sessions, which might partially explain the difference between the improvement or cure rates in women who did or did not receive biofeedback. Moreover, when only the outcome "no cure" was examined, there was no significant difference between groups that did and did not receive biofeedback (5 studies; relative risk, 0.92; 95% CI, 0.81 to 1.05). Among secondary outcomes, a pooled analysis of 7 trials did not find a significant difference in leakage episodes in a 24-hour period after treatment (mean difference, -0.01; 95% CI, -0.21 to 0.01). For the outcomes frequency and nocturia, data could not be combined but reviewers reported that the pattern was one of no difference between groups.

Randomized Controlled Trials
Selected larger RCTs that compared PFMT with and without biofeedback are summarized in this section. Hagen et al. (2020) conducted a multicenter RCT in 600 women with stress or mixed urinary incontinence.¹² Participants were randomized to 16 weeks of PFMT with electromyographic biofeedback or PFMT alone. Both groups received supervised PFMT during clinic appointments and a home PFMT regimen. The mean number of appointments attended was about 4 in both groups. Urinary incontinence symptoms (self-reported at month 24 via the International Consultation on Incontinence Questionnaire on Urinary Incontinence Short Form [ICIQ-UI-SF]) were similar in both groups (mean difference, -0.09; 95% CI, -0.92 to 0.75; p = .84). The ICIQ-UI-SF scores were also similar between groups at earlier times (6 and 12 months). At 24 months, the proportion of patients who achieved the study's definition of cure, improvement, and symptoms that were very much better or much better was similar between groups. Pelvic floor muscle strength and endurance was assessed at 6 months, with similar findings in both groups. A limitation of this study is the short duration of the intervention compared to the length of follow-up.

Williams et al. (2006) published a study that included 238 women who had failed a primary behavioral therapy (e.g., advice on fluid intake, bladder reeducation, weight loss) for 3 months.¹³ They were randomized to intensive PFMT (n = 79), PFMT using vaginal cones (n = 80), or continued behavioral therapy (n = 79) for 3 months. Patients in all 3 groups were seen in the clinic every other week for 8 weeks and at 12 weeks. At 12 weeks, all 3 groups had moderate reductions in incontinence episodes and some reduction in voiding frequency; there were no statistically significant differences in outcomes among the 3 groups. For example, the mean reduction in incontinence episodes over 24 hours was -1.03 in the PFMT group, -0.28 in the vaginal cone group, and -0.59 in the control group (p = .2).

Burgio et al. (2002) reported on the findings of an RCT with 222 women who had urge or mixed incontinence.² Interventions in this 3-armed trial were as follows: (1) 74 patients received behavioral training along with digital palpation instruction (no biofeedback) and 4 office visits in 8 weeks; (2) 73 patients received biofeedback-assisted behavioral training and 4 office visits in 8 weeks; and (3) 75 patients were given a self-help book with no office visits (control condition). Behavioral training in the 2 intervention groups included teaching pelvic floor exercises as well as skills and strategies for reducing incontinence. Patients in all groups kept bladder diaries through the 8 week treatment period. In an intention-to-treat analysis, the mean reduction in incontinence episodes was 69.4% in the behavioral training plus verbal feedback group, 63.1% in the behavioral training plus biofeedback group, and 58.6% in the control group. The 3 groups did not differ significantly from one another (p = .23). In addition, quality of life outcomes were similar in the 3 groups.

Other RCTs comparing the efficacy of PFMT alone with PFMT with biofeedback have been published.^14,15,16,17 They tended not to find statistically significant differences in outcomes between interventions; however, sample sizes were small (i.e., < 25 per group) and thus the studies might have been underpowered.

Section Summary: Women With Urinary Incontinence
Numerous RCTs and several systematic reviews have evaluated biofeedback as a treatment for urinary incontinence in women. Trial reporting methodologies varied, and many did not isolate the potential contribution of biofeedback. A comparative effectiveness review did not find a statistically significant difference in continence rates when patients received PFMT with or without biofeedback. Other systematic reviews evaluating biofeedback and/or verbal feedback as part of treatment for urinary incontinence found improvement in some outcomes (e.g., improvement or cure, urine volume) but not others (e.g., cure, leakage episodes). There is a lack of consistent evidence from well-designed trials to suggest that biofeedback is an effective treatment for urinary incontinence.

Men With Prostatectomy-related Urinary Incontinence
Clinical Context and Therapy Purpose
The purpose of biofeedback with PFMT in men who have post-prostatectomy urinary incontinence is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of biofeedback with PFMT improve the net health outcome in men with post-prostatectomy urinary incontinence?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is men with post-prostatectomy urinary incontinence.

Interventions
The therapy being considered is biofeedback with PFMT.

Comparators
The following therapy is currently being used to make decisions about urinary incontinence: PFMT without biofeedback.

Outcomes
The general outcomes of interest are symptom reduction and functional outcomes (approximately 8 weeks).¹⁸

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs. 
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
Hsu et al. (2016) published a systematic review of PFMT with biofeedback in men who had had a radical prostatectomy.¹⁹ Thirteen trials met reviewers' inclusion criteria. However, on inspection, not all trials included a biofeedback intervention, and other trials did not compare PFMT alone with PFMT plus biofeedback. Thus, conclusions about the added efficacy of biofeedback could not be determined from the results of this meta-analysis.

A Cochrane review by Anderson et al. (2015) assessed conservative treatments for post-prostatectomy urinary incontinence.²⁰ Reviewers included a comparison of PFMT (with or without biofeedback) and sham or no treatment. The authors did not evaluate the potential incremental value of biofeedback (i.e., by comparing PFMT with biofeedback and PFMT without biofeedback).

Previously, MacDonald et al. (2007) conducted a systematic review of PFMT to improve urinary incontinence after radical prostatectomy.²¹ Reviewers identified 3 studies (281 men) that compared biofeedback and PFMT with muscle training alone (written/verbal instructions provided). Study findings were not pooled; none of the individual trials included in the review found a statistically significant difference in outcomes between groups.

Randomized Controlled Trials
Goode et al. (2011) reported on an RCT evaluating biofeedback and PFMT in 208 men with urinary incontinence persisting at least 1 year after radical prostatectomy.18, Men with pre-prostatectomy incontinence were excluded. Participants were randomized to 1 of 3 groups: 8 weeks of behavioral therapy (PFMT and bladder control exercises; n = 70), behavioral therapy plus biofeedback and electric stimulation (n = 70), and a delayed-treatment control group (n = 68). The biofeedback and electric stimulation intervention, called "behavior-plus," consisted of in-office electric stimulation with biofeedback using an anal probe and daily home pelvic floor electrical stimulation. After 8 weeks, patients in the 2 active treatment groups were given instructions for a maintenance program of pelvic floor exercises and fluid control; they were assessed at 6 and 12 months. The primary efficacy outcome was a reduction in the number of incontinent episodes at 8 weeks, as measured by a 7 day bladder diary. A total of 176 (85%) of 208 randomized men completed the 8-week treatment. In an intention-to-treat analysis of the primary outcome, the mean reduction in incontinent episodes was 55% (28 to 13 episodes per week) in the behavioral therapy group, 51% (26 to 12 episodes per week) in the behavior-plus group, and 24% (25 to 20 episodes per week) in the control group. The overall difference between groups was statistically significant (p = .001), but the behavior plus intervention did not result in a significantly better outcome than behavioral therapy alone. Findings were similar to other outcomes. For example, at the end of 8 weeks, there was a significantly higher rate of complete continence in the active treatment groups (11/70 [16%] in the behavior group vs. 12/70 [17%] in the behavior-plus group) than the control group (4/68 [6%]), but the group receiving biofeedback and electrical stimulation did not have a significantly higher continence rate than the group receiving behavioral therapy alone.

Section Summary: Post-Prostatectomy Urinary Incontinence
An RCT and systematic reviews have evaluated the efficacy of biofeedback with PFMT for treatment of prostatectomy-related urinary incontinence compared with PFMT without biofeedback. Results of these data are mixed, and have not consistently reported significantly improved outcomes with biofeedback added to the intervention. The timing and delivery of the intervention were not well-defined. Systematic reviews have not pooled study findings.

Planned Radical Prostatectomy
Clinical Context and Therapy Purpose
The purpose of biofeedback with PFMT in men who are scheduled for radical prostatectomy is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of biofeedback with PFMT improve the net health outcome in men scheduled for radical prostatectomy?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is men scheduled for radical prostatectomy.

Interventions
The therapy being considered is biofeedback with PFMT.

Comparators
The following therapy is currently being used to make decisions about urinary incontinence: PFMT without biofeedback.

Outcomes
The general outcomes of interest are symptom prevention and functional outcomes (starting 2 to 4 weeks before the procedure and continuing after; follow-up 3 to 12 months).^22,23,24,25

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Randomized Controlled Trials
Several trials have evaluated the use of pre- or perioperative biofeedback for patients undergoing radical prostatectomy for prevention of postoperative urinary incontinence. Oh et al. (2020) randomized 84 patients undergoing robot-assisted laparoscopic radical prostatectomy to receive biofeedback with an extracorporeal perineometer plus PFMT or PFMT alone.²² Although the average urine loss volume was lower in the biofeedback plus PFMT group compared to PFMT alone at month 1 after catheter removal (p = .028), there was no difference between groups at months 2 or 3 after catheter removal. At study end (month 3), the percentage of continent patients was not significantly different between the biofeedback plus PFMT group (67.5%) and PFMT alone (61.9%).

Tienforti et al. (2012) reported on an RCT comparing biofeedback (sessions before and after surgery) plus pelvic floor muscle exercises with a control intervention PFMT alone in patients undergoing radical prostatectomy.²³ The trial enrolled 34 patients, 32 of whom (16 in each group) were available for the final 6-month analysis. By 6 months, 10 (62.5%) of 16 patients in the treatment group and 1 (6.3%) of 16 patients in the control group were continent (p = .002). The mean number of incontinence episodes per week was also significantly lower in the intervention group (2.7) than in the control group (13.1) at 6 months (p = .005).

A trial by Wille et al. (2003) randomized 139 men prior to radical prostatectomy to 1 of 3 groups.²⁴ Group 1 received verbal and written instructions about PFMT from a physical therapist. Group 2 received PFMT instruction and instruction on using an electrical stimulation device. Group 3 received the previous 2 intervention components and training on using biofeedback with the electrical stimulation device. Patients had regular contact with a health care provider for the first 5 weeks after surgery. In the immediate postsurgical period, 20.5% in group 1, 22.9% in group 2, and 20.7% in group 3 were continent (p = .815). After 6 and 12 months, continence rates remained similar among the groups. Twelve-month continence rates were 88% in group 1, 81% in group 2, and 88.6% in group 3 (p = .524).

Bales et al. (2000) randomized 100 men scheduled to undergo radical prostatectomy to PFMT plus biofeedback intervention (n = 50) or to a control group (n = 50) that received written and brief verbal instructions performing PFMT.²⁵ The intervention consisted of a single session with a trained nurse 2 to 4 weeks before surgery. Three men dropped out of the PFMT plus intervention group. At 6 months after surgery, there was no difference between groups; the incidence of urinary incontinence was 94% (44/47) in the PFMT plus biofeedback group and 96% (948/40) in the control group.

Tables 2 and 3 more fully summarize key trial characteristics and results of these trials.

Table 2. Summary of Key Randomized Controlled Trial Characteristics

Study; Trial	Countries	Sites	Dates	Participants	Interventions
					Active	Comparator
Oh et al. (2020)22	South Korea	1	2015 –2017	84 patients undergoing robot-assisted laparoscopic radical prostatectomy	Biofeedback (using extracorporeal device [Anykegel]) and PFMT after catheter removal (n = 42)	PFMT after catheter removal (n = 42)
Tienforti et al. (2012)23	Italy	1	2009 –2010	38 patients who underwent standard open retropubic radical prostatectomy for prostate cancer	Biofeedback (using anal probe [PelveenCare]) after catheter removal and PFMT (n = 16)	Verbal and written instructions on PFMT to be performed at home (n = 16)
Wille et al. (2003)24	Germany	1	1999 –2001	139 patients who underwent radical retropubic prostatectomy	Biofeedback (using anal probe) plus PFMT and electrical stimulation (n = 46)	Comparator 1: Verbal and written instructions about postoperative PFMT with intensive physiotherapy (n = 47) Comparator 2: PFMT and electrical stimulation (n = 46)
Bales et al. (2000)25	U.S.	1	NR	100 patients undergoing radical retropubic prostatectomy	Biofeedback and instructions on PFMT (n = 50)	Verbal and written instructions on PFMT (n = 50)

NR: not reported; PFMT: Pelvic floor muscle training.

Table 3. Summary of Key Randomized Controlled Trial Results

Study (Year)	Final N	Continence		Average 24-hour urine loss
Oh et al. (2020)22		Loss of 0 g of urine on a 24-h pad test
Biofeedback + PFMT	40	27/40 (67.5%) (3 months)		71.0 ± 48.0 g (month 1), 59.7 ± 83.4 g (month 2), 38.8 ± 141.2 g (month 3)
PFMT alone	42	26/42 (61.9%) (3 months)		120.8 ± 132.7 g (month 1), 53.1 ± 96.6 g (month 2), 19.5 ± 57.2 (month 3)
P value		.649		.028 (month 1),.744 (month 2),.415 (month 3)
Tienforti et al. (2012)23		ICIQ-UI score of 0
Biofeedback + PFMT	16	6/16 (month 1), 8/16 (month 2), 10/16 (month 3)		NR
PFMT	16	0/16 (month 1), 1/16 (month 2), 1/16 (month 3)		NR
P value		.02 (month 1),.01 (month 2),.002 (month 3)		NR
Wille et al. (2003)24		Assessed by questionnaire	Assessed by 20-minute pad testa
Biofeedback + PFMT + electrical stimulation	46	20.7% (immediate postsurgical period), 88.6% (12 months)	33% (immediate postsurgical), 90.5% (12 months)	NR
PFMT+ electrical stimulation	46	22.9% (immediate postsurgical period), 81% (12 months)	36.4% (immediate postsurgical), 82% (12 months)	NR
PFMT	47	20.5% (immediate postsurgical period), 88% (12 months)	29% (immediate postsurgical), 76.7% (12 months)	NR
P value		.815 (immediate postsurgical),.524 (12 months)	.822 (immediate postsurgical),.236 (12 months)	NR
Bales et al. (2000)25		Use of 1 or less pad per day
Biofeedback + PFMT	47	44/47 (94%) (6 months)		NR
PFMT	50	48/50 (96%) (6 months)		NR
P value		.596		NR

^aThe 20-minute pad test assesses continence by performing various activities with a bladder volume of 75% while wearing a pad to collect urine.
ICIQ-UI: International Consultation on Incontinence Questionnaire on Urinary Incontinence; NR: not reported; PFMT: pelvic floor muscle training.

Tables 4 and 5 display notable limitations in the trials. Major limitations include a limited number of outcomes assessed by trials (e.g., not including safety data), an inability to blind patients and/or the outcome assessment due to the nature of the intervention, unclear methods of allocation concealment, and missing power calculations. Although most studies did not include safety endpoints, biofeedback is generally considered a safe treatment.²³

Table 4. Study Relevance Limitations

Study; Trial	Populationa	Interventionb	Comparatorc	Outcomesd	Follow-upe
Oh et al. (2020)22				1. Key health outcomes not addressed; 3. No CONSORT reporting of harms
Tienforti et al. (2012)23			3. Delivery not similar intensity as intervention
Wille et al. (2003)24				1. Key health outcomes not addressed; 3. No CONSORT reporting of harms;
Bales et al. (2000)25			3. Delivery not similar intensity as intervention	1. Key health outcomes not addressed; 3. No CONSORT reporting of harms;

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
^b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator.
^c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
^d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
^e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 5. Study Design and Conduct Limitations

Study; Trial	Allocationa	Blindingb	Selective Reportingc	Data Completenessd	Powere	Statisticalf
Oh et al. (2020)22		1. Not blinded to treatment assignment; 2. Not blinded outcome assessment
Tienforti et al. (2012)23		1. Not blinded to treatment assignment
Wille et al. (2003)24	3. Allocation concealment unclear	1. Not blinded to treatment assignment; 2. Not blinded outcome assessment			1. Power calculations not reported
Bales et al. (2000)25	3. Allocation concealment unclear	1. Not blinded to treatment assignment			1. Power calculations not reported

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
^b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
^c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
^d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
^f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.

Section Summary: Men Scheduled for Radical Prostatectomy
RCTs have evaluated the efficacy of biofeedback with PFMT for prevention of prostatectomy-related urinary incontinence compared with PFMT without biofeedback. These trials generally did not report consistently improved outcomes with biofeedback added to the intervention. The timing and delivery of the intervention were not well-defined.

Summary of Evidence
For individuals who have urinary incontinence (women) who receive biofeedback with PFMT, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, and quality of life. A comparative effectiveness review did not find a statistically significant difference in continence rates when patients received PFMT with or without biofeedback. Other systematic reviews evaluating biofeedback and/or verbal feedback as part of treatment for urinary incontinence found improvement in some outcomes but not others. There is a lack of consistent evidence from well-designed trials that biofeedback effectively treats urinary incontinence. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have post-prostatectomy urinary incontinence, the evidence includes an RCT and systematic reviews that compared PFMT with or without biofeedback. Relevant outcomes are symptoms, functional outcomes, and quality of life. Results of these data were mixed, and did not consistently report significantly improved outcomes when biofeedback was added to the intervention. The timing and delivery of the intervention were not well-defined. Additional well-designed trials are needed that demonstrate the superiority of biofeedback with PFMT over PFMT alone. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who will undergo radical prostatectomy, RCTs have evaluated the efficacy of biofeedback with PFMT compared with PFMT without biofeedback for prevention of prostatectomy-related urinary incontinence. These trials generally did not report improved outcomes with biofeedback added to the intervention. The timing and delivery of the intervention were not well-defined. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Clinical Input From Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2009 Input
In response to requests, input was received from 4 physician specialty societies and 2 academic medical centers while this policy was under review in 2009. Clinical input varied. Several reviewers commented on the lack of data (e.g., those who cannot do pelvic exercises) as well as the inability to separate in the available literature the contribution of biofeedback to overall outcomes in many studies.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a U.S. professional society, an international society with U.S. representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Urological Association et al.
In their guidelines on treatment of stress urinary incontinence in women, the American Urological Association and Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (2017) recommended offering several treatment options including pelvic floor muscle training with biofeedback: "Pelvic floor muscle training and incontinence pessaries are appropriate for patients interested in pursuing therapy that is less invasive than surgical intervention. Pelvic floor physical therapy can be augmented with biofeedback in the appropriate patient. The patient must be willing and able to commit to regularly and consistently performing pelvic floor training for this to be successful."26

The American Urological Association/Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Guideline (2019) on treating incontinence after prostate treatment states that the randomized controlled trials that were assessed differed on the regimen of pelvic floor muscle training, with some studies including biofeedback or electrical stimulation.²⁷ Guideline Statement 16 recommends pelvic floor muscle exercises or pelvic floor muscle training after radical prostatectomy but biofeedback is not mentioned as part of the treatment.

American College of Obstetricians and Gynecologists and the American Urogynecologic Society
The American College of Obstetricians and Gynecologists and the American Urogynecologic Society (issued 2015; reaffirmed 2022) issued a practice bulletin on urinary incontinence in women.²⁸ The practice bulletin states, "Pelvic muscle exercises may be used alone or augmented with bladder training, biofeedback, or electrical stimulation."

National Institute for Health and Care Excellence
In 2019, the NICE updated its guidance on the management of urinary incontinence in women.²⁹ Recommendations on biofeedback included: "Do not use perineometry or pelvic floor electromyography as biofeedback as a routine part of pelvic floor muscle training" and "electrical stimulation and/or biofeedback should be considered in women who cannot actively contract pelvic floor muscles in order to aid motivation and adherence to therapy."

U.S. Preventive Services Task Force Recommendations
Not applicable.

Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in June 2022 did not identify any ongoing or unpublished trials that would likely influence this review.

References:  

1. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Biofeedback. TEC Assessments. 1995;Volume 10:Tab 25.
2. Burgio KL, Goode PS, Locher JL, et al. Behavioral training with and without biofeedback in the treatment of urge incontinence in older women: a randomized controlled trial. JAMA. Nov 13 2002; 288(18): 2293-9. PMID 12425706
3. Muscle strength. Physiopedia. Accessed June 15, 2022. https://www.physio-pedia.com/Muscle_Strength
4. Pelvic muscle function and strength. Physiopedia. Accessed June 15, 2022. https://www.physio-pedia.com/Pelvic_Floor_Muscle_Function_and_Strength
5. Zhu D, Xia Z, Yang Z. Effectiveness of physiotherapy for lower urinary tract symptoms in postpartum women: systematic review and meta-analysis. Int Urogynecol J. Mar 2022; 33(3): 507-521. PMID 34302516
6. Wu X, Zheng X, Yi X, et al. Electromyographic Biofeedback for Stress Urinary Incontinence or Pelvic Floor Dysfunction in Women: A Systematic Review and Meta-Analysis. Adv Ther. Aug 2021; 38(8): 4163-4177. PMID 34176082
7. Mateus-Vasconcelos ECL, Ribeiro AM, Antonio FI, et al. Physiotherapy methods to facilitate pelvic floor muscle contraction: A systematic review. Physiother Theory Pract. Jun 2018; 34(6): 420-432. PMID 29278967
8. Laycock J, Jerwood D. Pelvic floor muscle assessment: the PERFECT scheme. Physiotherapy. 2001;87(12):631-642. Accessed June 15, 2022. https://www.sciencedirect.com/science/article/abs/pii/S003194060561108X
9. Moroni RM, Magnani PS, Haddad JM, et al. Conservative Treatment of Stress Urinary Incontinence: A Systematic Review with Meta-analysis of Randomized Controlled Trials. Rev Bras Ginecol Obstet. Feb 2016; 38(2): 97-111. PMID 26883864
10. Shamliyan T, Wyman J, Kane RL, et al. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness. Comparative Effectiveness Review No. 36. Rockville, MD: Agency for Healthcare Research and Quality; 2012.
11. Herderschee R, Hay-Smith EJ, Herbison GP, et al. Feedback or biofeedback to augment pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. Jul 06 2011; (7): CD009252. PMID 21735442
12. Hagen S, Elders A, Stratton S, et al. Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial. BMJ. Oct 14 2020; 371: m3719. PMID 33055247
13. Williams KS, Assassa RP, Gillies CL, et al. A randomized controlled trial of the effectiveness of pelvic floor therapies for urodynamic stress and mixed incontinence. BJU Int. Nov 2006; 98(5): 1043-50. PMID 17034605
14. Hirakawa T, Suzuki S, Kato K, et al. Randomized controlled trial of pelvic floor muscle training with or without biofeedback for urinary incontinence. Int Urogynecol J. Aug 2013; 24(8): 1347-54. PMID 23306768
15. Pereira VS, de Melo MV, Correia GN, et al. Vaginal cone for postmenopausal women with stress urinary incontinence: randomized, controlled trial. Climacteric. Feb 2012; 15(1): 45-51. PMID 22066898
16. Bertotto A, Schvartzman R, Uchoa S, et al. Effect of electromyographic biofeedback as an add-on to pelvic floor muscle exercises on neuromuscular outcomes and quality of life in postmenopausal women with stress urinary incontinence: A randomized controlled trial. Neurourol Urodyn. Nov 2017; 36(8): 2142-2147. PMID 28508398
17. Ozlu A, Yildiz N, Oztekin O. Comparison of the efficacy of perineal and intravaginal biofeedback assisted pelvic floor muscle exercises in women with urodynamic stress urinary incontinence. Neurourol Urodyn. Nov 2017; 36(8): 2132-2141. PMID 28345778
18. Goode PS, Burgio KL, Johnson TM, et al. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: a randomized controlled trial. JAMA. Jan 12 2011; 305(2): 151-9. PMID 21224456
19. Hsu LF, Liao YM, Lai FC, et al. Beneficial effects of biofeedback-assisted pelvic floor muscle training in patients with urinary incontinence after radical prostatectomy: A systematic review and metaanalysis. Int J Nurs Stud. Aug 2016; 60: 99-111. PMID 27297372
20. Anderson CA, Omar MI, Campbell SE, et al. Conservative management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev. Jan 20 2015; 1: CD001843. PMID 25602133
21. MacDonald R, Fink HA, Huckabay C, et al. Pelvic floor muscle training to improve urinary incontinence after radical prostatectomy: a systematic review of effectiveness. BJU Int. Jul 2007; 100(1): 76-81. PMID 17433028
22. Oh JJ, Kim JK, Lee H, et al. Effect of personalized extracorporeal biofeedback device for pelvic floor muscle training on urinary incontinence after robot-assisted radical prostatectomy: A randomized controlled trial. Neurourol Urodyn. Feb 2020; 39(2): 674-681. PMID 31793032
23. Tienforti D, Sacco E, Marangi F, et al. Efficacy of an assisted low-intensity programme of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: a randomized controlled trial. BJU Int. Oct 2012; 110(7): 1004-10. PMID 22332815
24. Wille S, Sobottka A, Heidenreich A, et al. Pelvic floor exercises, electrical stimulation and biofeedback after radical prostatectomy: results of a prospective randomized trial. J Urol. Aug 2003; 170(2 Pt 1): 490-3. PMID 12853806
25. Bales GT, Gerber GS, Minor TX, et al. Effect of preoperative biofeedback/pelvic floor training on continence in men undergoing radical prostatectomy. Urology. Oct 01 2000; 56(4): 627-30. PMID 11018619
26. Kobashi KC, Albo ME, Dmochowski RR, et al. Surgical Treatment of Female Stress Urinary Incontinence: AUA/SUFU Guideline. J Urol. Oct 2017; 198(4): 875-883. PMID 28625508
27. Sandhu JS, Breyer BB, Comiter C, et al. Incontinence after Prostate Treatment: AUA/SUFU Guideline (2019). American Urological Association. 2019. Accessed June 15, 2022. https://www.auanet.org/guidelines/incontinence-after-prostate-treatment
28. ACOG Practice Bulletin No. 155: Urinary Incontinence in Women. Obstet Gynecol. Nov 2015; 126(5): e66-e81. PMID 26488524
29. National Institute for Health and Care Excellence (NICE) Guideline. Urinary Incontinence and Pelvic Organ Prolapse in Women: Management. NICE Guideline. 2019. Accessed June 15, 2022. https://www.nice.org.uk/guidance/ng123
30. Centers for Medicare & Medicaid Services. National coverage decision (NCD) for biofeedback therapy for the treatment of urinary incontinence (30.1.1). 2001. https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=42. Accessed June 20, 2022.

Coding Section

Codes	Number	Description
CPT	90875-90876	Individual psychophysiological therapy incorporating biofeedback training by any modality (face-to-face with the patient), with psychotherapy (e.g., insight oriented, behavior modifying, or supportive psychotherapy); code range
	90901	Biofeedback training by any modality
	90911	Biofeedback training, perineal muscles, anorectal or urethral sphincter, including electromyography (EMG) and/or manometry
	90912 (effective 01/01/2020)	Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and/or manometry, when performed; initial 15 minutes of one-on-one physician or other qualified health care professional contact with the patient
	90913 (effective 01/01/2020)	Each additional 15 minutes of one-on-one physician or other qualified health care professional contact with the patient
ICD-9 Procedure	89.21	Urinary manometry
	89.23	Urethral sphincter electromyogram
	93.08	Electromyography (EMG)
	94.39	Other individual psychotherapy (biofeedback)
ICD-9 Diagnosis		Investigational for all diagnoses
HCPCS	E0746	Electromyography (EMG), biofeedback device
ICD-10-CM (effective 10/01/15)		Investigational for all diagnoses
ICD-10-PCS (effective 10/01/15)		No applicable. ICD-10-PCS codes are only used for inpatient services. Policy is only for outpatient or home services.
	GZC9ZZZ	Biofeedback
Type of Service	Medicine
Place of Service	Outpatient

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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