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Meta-Analysis
. 2025 Mar 11;3(3):CD009252.
doi: 10.1002/14651858.CD009252.pub2.

Pelvic floor muscle training with feedback or biofeedback for urinary incontinence in women

Ana Carolina Nl Fernandes  1 , Cristine H Jorge  2 , Mark Weatherall  3 , Isadora V Ribeiro  1 , Sheila A Wallace  4 , E Jean C Hay-Smith  3
Affiliations
Meta-Analysis

Pelvic floor muscle training with feedback or biofeedback for urinary incontinence in women

Ana Carolina Nl Fernandes et al. Cochrane Database Syst Rev. .

Abstract

Background: Pelvic floor muscle training (PFMT), compared to no treatment, is effective for treating urinary incontinence (UI) in women. Feedback and biofeedback are additional resources that give women more information about their pelvic floor muscle contraction. The extra information could improve training performance by increasing capability or motivation for PFMT. The Committee on Conservative Management from the 7th International Consultation on Incontinence states that the benefit of adding biofeedback to PFMT is unclear. This review is an update of a Cochrane review last published in 2011.

Objectives: The primary objective was to assess the effects of PFMT with feedback or biofeedback, or both, for UI in women. We considered the following research questions. Are there differences in the effects of PFMT with feedback, biofeedback, or both versus PFMT without these adjuncts in the management of stress, urgency or mixed UI in women? Are there differences in the effects of feedback versus biofeedback as adjuncts to PFMT for women with UI? Are there differences in the effects of different types of biofeedback?

Search methods: We searched the Cochrane Incontinence Specialised Register (searched 27 September 2023), which includes searches of CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP as well as handsearching of journals and conference proceedings, and the reference lists of relevant articles.

Selection criteria: We included only randomised controlled trials (RCTs), cluster-RCTs and quasi-RCTs in women with UI. We excluded studies that recruited women with neurological conditions, who were pregnant or less than six months postpartum. Eligible studies made one of the following comparisons: PFMT plus feedback versus PFMT alone, PFMT plus biofeedback versus PFMT alone, PFMT plus feedback or biofeedback versus PFMT alone, PFMT plus feedback versus PFMT plus biofeedback, and one type of biofeedback versus another.

Data collection and analysis: Two review authors independently assessed studies for eligibility, extracted data onto a prepiloted form, and assessed risk of bias using RoB 1. We used the GRADE approach to assess the certainty of evidence in each comparison by outcome. Our primary outcome was lower urinary tract symptom-specific quality of life. We pooled data using a standardised mean difference (SMD). Secondary outcomes were leakage episodes in 24 hours (mean difference (MD)), leakage severity (MD), subjective cure or improvement (odds ratio (OR)), satisfaction (OR), and adverse events (descriptive summary).

Main results: We included 41 completed studies with 3483 women. Most (33 studies, 3031 women) investigated the effect of PFMT with biofeedback versus PFMT alone. Eleven studies were at low risk of bias overall, 27 at unclear risk of bias, and three at high risk. Only one study reported leakage severity, with no usable data. Comparison 1. PFMT with feedback versus PFMT alone: one eligible study reported no outcome of interest. Comparison 2. PFMT with biofeedback versus PFMT alone: there was little or no difference in incontinence quality of life (SMD 0.07 lower, 95% confidence interval (CI) 0.18 lower to 0.05 higher; 11 studies, 1169 women; high-certainty evidence). Women randomised to biofeedback had 0.29 fewer leakage episodes in 24 hours versus PFMT alone (MD 0.29 lower, 95% CI 0.42 lower to 0.16 lower; 12 studies, 932 women; moderate-certainty evidence), but this slight reduction in leakage episodes may not be clinically important. Women in biofeedback arms report that there is probably little to no difference in cure or improvement (OR 1.26, 95% CI 1.00 to 1.58; 14 studies, 1383 women; moderate-certainty evidence) but may report greater satisfaction with treatment outcomes (OR 2.41, 95% CI 1.56 to 3.7; 6 studies, 390 women; low-certainty evidence). None of these outcomes were blinded. Eight studies (711 women) assessed severe adverse events but reported that there were no events. Comparison 3. PFMT with feedback or biofeedback versus PFMT alone: a single study contributed very-low certainty evidence regarding leakage episodes in 24 hours, subjective cure or improvement, and satisfaction. Comparison 4. PFMT with feedback versus PFMT with biofeedback: the evidence is very uncertain about any difference in effect between biofeedback versus feedback for incontinence-related quality of life. Not only is the evidence certainty very low, the confidence interval is very wide and there could be a more than small effect in favour of biofeedack or feedback (SMD 0.14 lower, 95% CI 0.56 lower to 0.28 higher; 2 studies, 91 women; very-low certainty evidence). There may be fewer leakage episodes in 24 hours for women receiving biofeedback verus feedback but the difference may not be clinically important and the evidence certainty is low (MD 0.28 lower, 95% CI 0.62 lower to 0.07 higher; 2 studies, 120 women; low-certainty evidence). There were no data for subjective cure, improvement or satisfaction. One study measured adverse events and none were reported. Comparison 5. PFMT with biofeedback versus PFMT with another type of biofeedback: five studies assessed this comparison, with individual studies contributing data for separate outcomes. There was low- or very-low certainty evidence about the benefits of one type of biofeedback versus another for leakage episodes in 24 hours or subjective cure or improvement, respectively. One study reported adverse events from two of nine women receiving electromyography biofeedback versus six of 10 receiving pressure biofeedback.

Authors' conclusions: PFMT with biofeedback results in little to no difference in incontinence quality of life. The addition of biofeedback to PFMT likely results in a small unimportant difference in leakage episodes in 24 hours, and likely little to no difference in patient-reported cure or improvement. Satisfaction may increase slightly for PFMT with biofeedback, based on low-certainty evidence. Five of the 33 studies in this comparison collected information about adverse events, and four reported none in either group. Adverse events reported by women using biofeedback seemed related to using a vaginal or rectal device (e.g. discomfort with device in place, vaginal discharge). The other comparisons had few, small studies, and low- to very low-certainty evidence for all outcomes. None of the studies reported any severe adverse events.

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Conflict of interest statement

Per Cochrane's Commercial Sponsorship Policy, the following declarations are applicable for the three years before the publication date of this review.

ACNLF declares no conflict of interest. ACNLF is an author of an ongoing study included in the review (NCT05194137). She was not involved in the screening, assessment or data extraction for the study.

IVR declares no conflict of interest.

CHJ declares no conflict of interest. CHJ is an author of an ongoing study included in the review (NCT05194137). She was not involved in the screening, assessment or data extraction for the study.

MW declares no conflict of interest.

SW is a former Cochrane Incontinence editor but was not involved in any editorial process for the present review.

EJCHS is a former Cochrane Incontinence editor but was not involved in any editorial process for the present review. EJCHS is an author of an included study (Hagen 2020). EJCHS was not involved in the screening, assessment or data extraction for Hagen 2020. EJCHS has shares in EBOS (a healthcare supplies company, including incontinence products).

Update of

References

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    1. Wong KS, Fung BK, Fung ES, Fung LC, Tang LC. Randomized prospective study of the effectiveness of pelvic floor training using biofeedback in the treatment of genuine stress urinary incontinence in Chinese population. In: International Continence Society (ICS), 27th Annual Meeting. 1997:57-8.
Wong 2001 {published data only}
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References to studies excluded from this review

Badda 2019 {published data only}
    1. Badda P, Batra A, Marwah S, Dewan R. Pelvic floor muscle training with and without biofeedback in treatment of overactive bladder. Obstetrics and Gynecology 2019;8(8):2997-3004.
ChiCTR‐IOR‐17012209 {published data only}
    1. ChiCTR-IOR-17012209. Clinical study to evaluate the safety and efficacy of pelvic floor biological stimulation feedback instrument. https://www.chictr.org.cn/showprojEN.html?proj=20618 first posted 01 August 2017.
de Figueire do Pinheiro 2012 {published data only}
    1. Figueire do Pinheiro B, Franco GR, Feitosa SM, Yuaso DR, Castro RA, Girao MJ. Physiotherapy for perineal consciousness: a comparison between pelvic floor muscle training alone and with biofeedback. Fisioterapia em Movimento 2012;25(3):639-48.
IRCT201506246083N9 {published data only}
    1. IRCT201506246083N9. Comparing the efficacy of biofeedback and exercise in treatment urinary incontinence. https://irct.behdasht.gov.ir/trial/6535 first posted 21 September 2015.
IRCT20230305057630N1 {published data only}
    1. IRCT20230305057630N1. Comparing the effects of biofeedback and brain stimulation treatments on pelvic floor muscle function in women with urinary incontinence. https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20230305057630N1 first posted 09 May 2023.
Kastelein 2020 {published data only}
    1. Kastelein A, Angles-Acedo S, Tervo J, Opmeer B, Soler V, Pages A, et al. Serious game-enhanced biofeedback-supported remotely supervised self-management versus pelvic physiotherapy for stress urinary incontinence-a multinational randomized controlled trial. International Urogynecology Journal 2020;31 Suppl 1:S5-6.
    1. NL-OMON47256. Women-UP trial. https://onderzoekmetmensen.nl/en/trial/47256 first posted 30 August 2016.
Na 2011 {published data only}
    1. Na Y, Lim J, Song K, Sul C, Shin J, Oh T, et al. Effectiveness of biofeedback training with ExTT-101 (trademark) in female stress urinary incontinence: portable self education system. International Urogynecology Journal and Pelvic Floor Dysfunction 2011;22 Suppl 3:S1819.
NCT02954042 {published data only}
    1. NCT02954042. Pelvital Stress Urinary Incontinence Training Device: P-SUIT. https://clinicaltrials.gov/show/NCT02954042 first posted 28 October 2016.
    1. Nakib N, Sutherland SE, Hallman KA. Novel pelvic floor treatment with mechanotherapy: clinical trial 24-hr pad weight results in women with stress urinary incontinence. Female Pelvic Medicine & Reconstructive Surgery 2020;26(10 Suppl 1):S140.
    1. Nakib N, Sutherland SE, Hallman KA. Novel pelvic floortreatmentwith mechanotherapy: clinical trial quality of life results in women with stress urinary incontinence. Female Pelvic Medicine & Reconstructive Surgery 2020;26(10 Suppl 1):S147.
    1. Nakib NJ, Mianulli M, Sutherland SE. Novel pelvic floor muscle trainer with mechanotherapy: clinical trial interim results in women with stress urinary incontinence (SUI). Neurourology and Urodynamics 2019;38 Suppl S3:S350-1.
    1. Nakib NJ, Sutherland SE, Hallman KA, Boulware DJ, Chrouser K. The effect of pelvic floor muscle conditioning on 24-hr pad weight, voiding frequency and quality of life using an innovative conditioning device during PFMT in women with stress urinary incontinence. International Urogynecology Journal 2019;30 Suppl 1:S111.
Ong 2015 {published data only}
    1. Anonymous. Erratum: using the Vibrance Kegel device with pelvic floor muscle exercise for stress urinary incontinence: a randomized controlled pilot study. Urology 2017;99:294. - PubMed
    1. Jesse T, Teng A, Azad R, Keng L, Su Y, Prevathe P, et al. A randomized control trial to compare the effectiveness of pelvic floor exercises with the Vibrance Kegel device compared to standard Kegel pelvic floor exercises for the treatment of stress urinary incontinence in females. International Journal of Urology 2012;19:214.
    1. Ng KL, Ting JR, Ong TA, Khong SY, Razack AH. Randomised controlled trial comparing standard pelvic floor muscle exercises versus Vibrance Kegel device enhanced pelvic floor muscle exercises in women with urinary stress incontinence. BJU International 2013;111:107-8.
    1. Ong TA, Khong SY, Ng KL, Ting JR, Kamal N, Yeoh WS, et al. Using the Vibrance Kegel device with pelvic floor muscle exercise for stress urinary incontinence: a randomized controlled pilot study. Urology 2015;86(3):487-91. - PubMed
    1. Swire JR, Teng AT, Su Yen KO, Razack AH, Ning Yi Y, Kamal N, et al. A randomized controlled trial on the use of a novel physical contact biofeedback device for female stress urinary incontinence. Neurourology and Urodynamics 2016;35(S4):S264-5.
Sherman 1997 {published data only}
    1. Sherman RA, Davis GD, Wong MF. Behavioral treatment of exercise-induced urinary incontinence among female soldiers. Military Medicine 1997;162(10):690-4. - PubMed
Sung 2000 {published data only}
    1. Sung MS, Choi YH, Back SH, Hong JY, Yoon H. The effect of pelvic floor muscle exercises on genuine stress incontinence among Korean women--focusing on its effects on the quality of life. Yonsei Medical Journal 2000;41(2):237-51. - PubMed
Williams 2006 {published data only}
    1. Williams KS, Assassa RP, Gillies CL, Abrams KR, Turner DA, Shaw C. A randomized controlled trial of the effectiveness of pelvic floor therapies for urodynamic stress and mixed incontinence. BJU International 2006;98(5):1043-50. - PubMed

References to ongoing studies

ChiCTR2300074915 {published data only}
    1. ChiCTR2300074915. Observations on the efficacy of physical therapy on female stress urinary incontinence. https://www.chictr.org.cn/showproj.html?proj=203256 first posted 21 October 2023.
CTRI/2021/08/035356 {published data only}
    1. CTRI/2021/08/035356. Effect of customised pelvic exercise with audio visual feedback in improving pelvic floor muscle performance in pelvic floor dysfunction among women. http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54437 first posted 3 October 2021.
CTRI/2022/02/040624 {published data only}
    1. CTRI/2022/02/040624. Effect of PF360 a non invasive pelvic floor technology vs Surface EMG on pelvic floor muscle performance in females with pelvic floor weakness. https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2022/02/040624 first posted 01 February 2022.
de Azevedo Ferreira 2020 {published data only (unpublished sought but not used)}
    1. Ferreira LA, Gimenez MM, Matias MM, Fitz FF, Bortolini M, Castro RA. Does educational program of pelvic floor muscle with vaginal palpation improve the motor control of the pelvic floor muscle of women with urinary incontinence? A randomized controlled trial. Female Pelvic Medicine & Reconstructive Surgery 2019;25(5 Suppl 1):S275-6.
    1. Ferreira LA, Gimenez MM, Matias MM, Fitz FF, Bortolini M. Does educational program of pelvic floor muscle with vaginal palpation improve the motor control of the pelvic floor muscle of women with urinary incontinence? A randomized controlled trial. International Urogynecology Journal 2019;30(1 Suppl):S319.
    1. NCT03325543. Can women correctly contract their pelvic floor muscles after to receive verbal instructions and vaginal palpation? https://clinicaltrials.gov/show/NCT03325543 first posted 16 October 2017.
    1. Azevedo Ferreira L, Fitz FF, Gimenez MM, Matias MM, Bortolini MA, Castro RA. The role of vaginal palpation in motor learning of the pelvic floor muscles for women with stress urinary incontinence: study protocol for a randomized controlled trial. Trials 2020;21(1):693. - PMC - PubMed
DRKS00027319 {published data only}
    1. DRKS00027319. Prospective, multicenter, randomized, controlled, single-blind other clinical trial. "What is the efficacy of pelvic floor biofeedback training with ACTICORE1® for stress incontinence?". https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00027319 first posted 19 January 2022.
IRCT20201130049543N2 {published data only}
    1. IRCT20201130049543N2. The effects of adding biofeedback to the pelvic floor muscles strengthening exercises on the treatment of women with urinary incontinence, a single-blinded randomized clinical trial. https://irct.behdasht.gov.ir/trial/55301 first posted 19 June 2021.
IRCT20211121053129N1 {published data only}
    1. IRCT20211121053129N1. Effectiveness of Tele-rehabilitation for supervised pelvic floor motor learning exercise with biofeedback in subjects with stress urinary incontinence (SUI). https://irct.behdasht.gov.ir/trial/60122 first posted 01 December 2021.
IRCT20220804055615N2 {published data only}
    1. IRCT20220804055615N2. Effectiveness of pelvic floor muscle training with or without biofeedback therapy for urinary incontinence. https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20220804055615N2 first posted 8 December 2022.
NCT04334798 {published data only}
    1. NCT04334798. Effectiveness of different modalities of motor learning of pelvic floor muscle contraction in women with pelvic floor dysfunction: randomized controlled trial. https://clinicaltrials.gov/show/NCT04334798 first posted 02 April 2020.
NCT04336150 {published data only}
    1. NCT04336150. Effectiveness of different hypopressive exercises in pelvic floor dysfunction. https://clinicaltrials.gov/show/NCT04336150 first posted 31 March 2020.
NCT05194137 {published data only}
    1. NCT05194137. Biofeedback versus vaginal palpation to teach a voluntary pelvic floor muscle contraction [Biofeedback versus vaginal palpation to teach a voluntary pelvic floor muscle contraction to women incapable of performing it? a non-inferiority randomized controled trial]. https://clinicaltrials.gov/show/NCT05194137 first posted 03 January 2022.
NCT05366426 {published data only}
    1. NCT05366426. Effect of EMG biofeedback in female patients with stress urinary incontinence. https://clinicaltrials.gov/show/NCT05366426 first posted 05 May 2022.
NCT05399901 {published data only}
    1. NCT05399901. M-mode ultrasonography in the assessment and treatment of pelviperineal dysfunctions (PerineUM). https://clinicaltrials.gov/show/NCT05399901 first posted 23 May 2022.
NCT05627726 {published data only}
    1. NCT05627726. Effectiveness and cost-effectiveness of PelviSense, a novel biofeedback device for stress urinary incontinence in women. https://clinicaltrials.gov/show/NCT05627726 first posted 13 November 2022.
NCT05771597 {published data only}
    1. NCT05771597. Home biofeedback therapy for dyssynergic defecation, fecal incontinence and urinary incontinence. https://clinicaltrials.gov/show/NCT05771597 first posted 30 January 2023.
NCT06014021 {published data only}
    1. NCT06014021. Tele-rehabilitation for female athletes with pelvic floor dysfunctions. https://clinicaltrials.gov/ct2/show/NCT06014021 first posted 22 August 2023.
Ruff 2004 {published data only}
    1. Ruff CC. Behavioral therapy for UI in African American women. Journal of Gynaecology and Obstetrics 2004.

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References to other published versions of this review

Herderschee 2011
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