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Pelvic floor muscle training for the management of symptoms

Pelvic floor dysfunction: prevention and non-surgical management

Evidence review M

NICE Guideline, No. 210

.

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-4364-7

Pelvic floor muscle training for the management of symptoms

Review question

What is the effectiveness of pelvic floor muscle training (including Kegel exercises, biofeedback, weighted vaginal cones, and electrical stimulation) for improving symptoms of pelvic floor dysfunction?

Introduction

There are a number of non-surgical management options for the symptoms of pelvic floor dysfunction (PFD) including: pelvic floor muscle training (PFMT), vaginal cones (VC), biofeedback (BF) and electrical stimulation (ES). This review aims to establish whether these interventions are effective and acceptable to women with PFD.

Summary of the protocol

See Table 1 for a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of this review.

Table 1. Summary of the protocol (PICO table).

Table 1

Summary of the protocol (PICO table).

For further details, see the review protocol in appendix A.

Methods and process

This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual. Methods specific to this review question are described in the review protocol in appendix A and the methods document (supplementary document 1).

Declarations of interest were recorded according to NICE’s conflicts of interest policy.

Clinical evidence

Included studies
Systematic reviews

15 systematic reviews of randomised controlled trials (RCTs) were included for this review (Dumoulin 2018, Ge 2020, Hagen 2011, Hay-Smith 2011, Herderschee 2011, Herbison 2013, Imamura 2010, Liang 2018, Lim 2015, Moroni 2016, Nie 2017, Oblasser 2015, Peng 2019, Stewart 2017, Woodley 2020). One of these studies conducted a network meta-analysis (Liang 2018). Randomised controlled trials published since these systematic reviews were also included (see randomised trials section below).

One systematic review included only studies in antenatal or postnatal women (Woodley 2020) and one review included only studies in postnatal women (Oblasser 2015). Two reviews excluded studies in antenatal or postnatal women (Dumoulin 2018 and Hay-Smith 2011). The remainder of the reviews included studies in any adult woman with relevant symptoms (Ge 2020, Hagen 2011, Herbison 2013, Herderschee 2011, Imamura 2010, Liang 2018, Lim 2015, Moroni 2016, Nie 2017, Peng 2019, Stewart 2017).

The included systematic reviews are summarised in Table 2. Randomised controlled trials published since these systematic reviews are summarised in Table 3.

Comparisons of individual treatments

For the comparison of PFMT versus no treatment (or inactive control) there were:

For the comparison of PFMT versus usual care, there was:

  • 1 systematic review of antenatal treatment and prevention of urinary and faecal incontinence (Woodley 2020)
  • 1 systematic review of postnatal treatment for urinary and faecal incontinence (Woodley 2020)

For the comparison of magnetic stimulation versus sham treatment, there was:

  • 1 systematic review in women with SUI (Peng 2019)
  • 1 systematic review in women with UI (Lim 2015)

For the comparison of vaginal cones versus no treatment, there were:

For the comparison of electrical stimulation versus no treatment, there were:

For the comparison of electrical stimulation versus sham treatment, there was:

For the comparison of PFMT versus electrical stimulation, there was:

For the comparison of PFMT versus vaginal cones, there were:

For the comparison of PFMT versus PFMT + biofeedback, there was:

  • 1 network meta-analysis in women with UI (Liang 2018)

For the comparison of PFMT + biofeedback versus electrical stimulation there was:

  • 1 network meta-analysis in women with UI (Liang 2018)

For the comparison of electrical stimulation versus vaginal cones, there were:

For the comparison of vaginal cones versus PFMT + biofeedback, there was:

  • 1 network meta-analysis in women with SUI (Liang 2018)

For the comparison of PFMT with more versus less contact with health professionals there was

For the comparison of group PFMT versus individual PFMT there was

For the comparison of direct PFMT (for example voluntary pelvic floor muscle contraction) versus indirect PFMT (for example pelvic floor muscle contraction facilitated through abdominal muscle contraction) there was

For the comparison of individualised PFMT versus generic PFMT there was

For the comparison of daily PFMT versus PFMT 3 times per week there was

For the comparison of upright and supine PFMT versus supine only PFMT there was

For the comparison of more intensive PFMT versus less intensive PFMT there was

Comparisons of PFMT + other treatment versus PFMT alone

This review also included PFMT + treatment versus PFMT combination comparisons.

For the comparison of PFMT + biofeedback versus PFMT there was:

For the comparison of PFMT + feedback versus PFMT there was:

For the comparison of PFMT + vaginal cones versus PFMT there was:

For the comparison of PFMT + electrical stimulation versus PFMT there was:

For the comparison of PFMT (strength + motor learning) versus PFMT (motor learning alone) there was:

For the comparison of PFMT + abdominal exercise versus PFMT there was:

For the comparison of PFMT + intravaginal device versus PFMT there was:

For the comparison of PFMT + adherence strategy versus PFMT there was:

Randomised trials

Twenty RCTs, reported in 22 articles, published since the systematic reviews were also included (Al Belushi 2020, Araujo 2020, Dumoulin 2020, Figueiredo 2020, Fitz 2020, Gungor Ugurlucan 2013, Hagen 2020a, Hagen 2020b, Huang 2020a, Huang 2020b, Jha 2018, Karaman 2020, Kucukkaya 2020, Liang 2019, Mallman 2020, Mundet 2020, Navarro-Brazalez 2020, Nyhus 2020, Okayama 2019, Ptak 2020, Teixeira Alve 2020).

The included RCTs are summarised in Table 3.

Comparisons of individual treatments

For the comparison of PFMT versus no treatment (or inactive control) there were:

For the comparison of electrical stimulation versus no treatment, there was:

For the comparison of electrical stimulation versus percutaneous tibial nerve stimulation, there were:

For the comparison of individual versus group PFMT there were:

For the comparison of outpatient versus home based PFMT there was:

For the comparison of app-based versus written PFMT there was:

  • 1 RCT in women with SUI

Comparisons of PFMT plus other treatment versus PFMT alone

For the comparison of PFMT plus biofeedback versus PFMT alone there was:

For the comparison of PFMT plus electrical stimulation versus PFMT alone there was:

For the comparison of PFMT plus abdominal excercise versus PFMT alone there were:

See the literature search strategy in appendix B and study selection flow chart in appendix C.

Excluded studies

Studies not included in this review are listed, and reasons for their exclusion are provided in appendix K.

Summary of studies included in the evidence review

Summaries of the studies that were included in this review are presented in Table 2.

Table 2. Summary of included systematic reviews.

Table 2

Summary of included systematic reviews.

Table 3. Summary of additional RCTs published since the included systematic reviews.

Table 3

Summary of additional RCTs published since the included systematic reviews.

See the full evidence tables in appendix D. No meta-analysis was conducted (and so there are no forest plots in appendix E).

Quality assessment of studies included in the evidence review

See the evidence profiles in appendix F.

Economic evidence

Included studies

A single economic search was undertaken for all topics included in the scope of this guideline. One economic study was identified which was relevant to this question (Panman 2017).

See the literature search strategy in appendix B and economic study selection flow chart in appendix G.

Excluded studies

Economic studies not included in this review are listed, and reasons for their exclusion are provided in appendix K.

Summary of studies included in the economic evidence review

See the economic evidence tables in appendix H and economic evidence profiles in appendix I.

One Dutch study (Panman 2017) compared the cost-utility of PFMT with watchful waiting in women aged ≥ 55 years with pelvic organ prolapse. The economic evaluation was conducted alongside a randomised controlled trial. Costs were based on a 2013 price year and included the costs of consultations, consummables and prolapse related treatments. QALYs were derived from the EQ-5D questionnaire based on a UK tariff. Mean costs were €239 per person higher in the PFMT group (95% confidence interval: €161 to €319). The incremental cost-effectiveness ratio was calculated as €31,983 (95% confidence interval: −€76652 to €88078), which could be considered borderline cost-effective at a cost-effectiveness threshold of £20000 to £30000 per QALY using the exchange rate at the time of writing (£1 = €1.3796, https://www.bankofengland.co.uk/statistics/exchange-rates). Bootstrap simulation estimated that there was a 55% probability that PFMT would result in an incremental QALY gain when compared to watchful waiting, although no cost-effectiveness threshold was specified and therefore the study does not report on a probability cost-effective.

Economic model

Although this was initially prioritised for economic analysis, no economic modelling was undertaken for this review. This was because the committee agreed that other topics were higher priorities for economic evaluation and because the committee considered that their recommendations would not represent a large change from current practice and related NICE guidance.

Brief summary of the evidence

Comparison 1. Pelvic floor muscle training (PFMT) versus no treatment (or inactive control)
Subjective change in symptoms
  • Women with POP:
    • Moderate quality evidence from 1 systematic review showed a clinically important improvement in subjective POP symptoms with PFMT when compared to no treatment.
    • Moderate to high quality evidence from 1 systematic review showed that women with flatus leakage or loose faecal incontinence were less likely to report an increase in symptom bother after PFMT when compared to no treatment.
    • Low quality evidence from 1 systematic review showed no clinically important difference in the rates of increased symptom bother in women with solid faecal incontinence or bowel emptying difficulty after PFMT when compared to no treatment.
    • Very low quality evidence from 1 systematic review showed inconsistent results in terms of subjective change in symptoms for PFMT compared to no treatment or inactive controls.
    • Very low to low quality evidence from 2 RCTs showed no difference between PFMT and no treatment for subjective change in symptoms.
  • Women with SUI:
    • Very low to high quality evidence from 3 systematic reviews showed a clinically important improvement in subjective SUI symptoms with PFMT when compared to no treatment.
    • Very low to low quality evidence from 2 RCTs showed a clinically important improvement in symptoms in terms of SUI symptoms with PFMT compared to no treatment.
  • Women with UI:
    • Very low to moderate quality evidence from 3 systematic reviews showed a clinically important improvement in subjective UI symptoms with PFMT when compared to no treatment.
  • Antenatal treatment/prevention of faecal/urinary incontinence (FI/UI):
    • Very low quality evidence from 1 systematic review showed a clinically important improvement in subjective UI symptoms with antenatal PFMT when compared to no treatment.
  • Postnatal treatment/prevention of FI/UI:
    • Low quality evidence from 1 systematic review showed no difference in sexual function related quality of life at 10 months post-partum with postnatal PFMT when compared to no treatment.
Satisfaction with intervention
  • Women with POP:
    • Moderate quality evidence from 1 systematic review showed women were more satisfied with PFMT than with no treatment.
  • Women with SUI:
    • Moderate quality evidence from 1 systematic review showed women were more satisfied with PFMT than with no treatment.
  • Women with UI:
    • Moderate quality evidence from 1 systematic review showed women were more satisfied with PFMT than with no treatment
Adherence to intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes.
Comparison 2. Pelvic floor muscle training (PFMT) versus usual care
Subjective change in symptoms
  • Antenatal treatment/prevention of FI/UI:
    • Very low quality evidence from 1 systematic review showed a clinically important improvement in subjective incontinence symptoms and sexual function with antenatal PFMT when compared to usual care.
  • Postnatal treatment/prevention of FI/UI:
    • Low quality evidence from 1 systematic review showed a clinically important improvement in subjective UI symptoms with postnatal PFMT when compared to usual care.
Anxiety and depression
  • Postnatal treatment/prevention of FI/UI:
    • Low quality evidence from 1 systematic review showed a clinically important improvement in anxiety and depression with postnatal PFMT when compared to usual care.
Satisfaction with intervention, adherence to intervention, and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes.
Comparison 3. Magnetic stimulation versus sham treatment
Subjective change in symptoms
  • Women with SUI:
    • Moderate quality evidence from 1 systematic review showed a clinically important benefit in terms of quality of life with magnetic stimulation when compared to sham treatment.
  • Women with UI:
    • Moderate quality evidence from 1 systematic review showed a clinically important benefit in terms of the number of women with improvements in incontinence with magnetic stimulation when compared to sham treatment.
Satisfaction with intervention, adherence to intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes.
Comparison 4. Vaginal cones versus no treatment
Subjective change in symptoms
  • Women with SUI:
    • Very low quality evidence from 2 systematic reviews showed inconsistent findings about the benefits of vaginal cones when compared with no treatment for subjective SUI symptoms.
  • Post-natal women with UI:
    • Very low quality evidence from 1 systematic review showed a benefit of vaginal cones when compared with no treatment for subjective UI symptoms at 1 year follow-up but not at 2 years follow-up.
Satisfaction with intervention, adherence to intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes.
Comparison 5. Electrical stimulation versus no treatment
Subjective change in symptoms
  • Women with SUI:
    • Very low to low quality evidence from 3 systematic reviews showed a clinically important reduction in subjective SUI symptoms with electrical stimulation when compared to no treatment.
    • Very low quality evidence from 1 RCT showed a possible clinically important benefit and no clinically important difference in subjective SUI symptoms compared to no treatment.
  • Women with OAB:
    • Low quality evidence from 1 RCT showed a possible clinically important benefit of electrical stimulation in terms of subjective change in symptoms compared to no treatment.
Adherence to intervention
  • Women with OAB:
    • Low quality evidence from 1 RCT showed no clinically important difference in adherence between electrical stimulation and no treatment.
Satisfaction with intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes.
Comparison 6. Electrical stimulation versus sham treatment
Subjective change in symptoms
  • Women with SUI:
    • Very low quality evidence from 1 systematic review showed a clinically important reduction in subjective SUI symptoms with electrical stimulation when compared to sham treatment.
Satisfaction with intervention, adherence to intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes.
Comparison 7. PFMT versus electrical stimulation
Subjective change in symptoms
  • Women with SUI:
    • Very low quality evidence from 2 systematic reviews showed no difference in subjective SUI symptoms with PFMT when compared to electrical stimulation.
    • Very low quality evidence from 1 network meta-analysis, however, indicated better incontinence related quality of life with PFMT than with electrical stimulation.
Satisfaction with intervention, adherence to intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes.
Comparison 8. PFMT versus vaginal cones
Subjective change in symptoms
  • Women with SUI:
    • Very low to moderate quality evidence from 3 systematic reviews and 1 network meta-analysis showed no difference in subjective SUI symptoms with PFMT when compared to vaginal cones
  • Post-natal women with UI:
    • Very low quality evidence from 1 systematic review showed no difference in subjective UI symptoms with PFMT when compared to vaginal cones
Satisfaction with intervention, adherence to intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes.
Comparison 9. PFMT + biofeedback versus electrical stimulation
Subjective change in symptoms
  • Women with SUI:
    • Very low quality evidence from 1 network meta-analysis indicated better incontinence related quality of life with PFMT+biofeedback than with electrical stimulation.
Satisfaction with intervention, adherence to intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes.
Comparison 10. Electrical stimulation versus vaginal cones
Subjective change in symptoms
  • Women with SUI:
    • Very low quality evidence from 4 systematic reviews showed no difference in subjective SUI symptoms with electrical stimulation when compared to vaginal cones.
    • Very low quality evidence from 1 network meta-analysis, however, indicated better incontinence related quality of life with vaginal cones than with electrical stimulation.
  • Women with UI:
    • Very low quality evidence from 1 systematic review showed no difference in subjective UI symptoms with PFMT when compared to vaginal cones
Satisfaction with intervention, adherence to intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes.
Comparison 11. Electrical stimulation versus PTNS
Subjective change in symptoms
  • Women with OAB:
    • Very low quality evidence from one RCT indicated a possible clinical benefit of electrical stimulation in terms of the subjective severity of symptoms (mild and moderate), but a possible benefit of PTNS in terms of the subjective severity of symptoms (severe).
    • Low quality evidence from 1 RCT showed no difference between interventions in terms of quality of life and subjective severity of symptoms (very severe), however very low quality evidence from another RCT showed a clinically important benefit of electrical stimulation in terms of total quality of life score compared to PTNS.
Satisfaction with intervention, adherence to intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes.
Comparison 12. Vaginal cones versus PFMT + biofeedback
Subjective change in symptoms
  • Women with SUI:
    • Very low quality evidence from 1 network meta-analysis indicated no difference in incontinence related quality of life with vaginal cones compared to PFMT + biofeedback.
Satisfaction with intervention, adherence to intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes.
Comparison 13. PFMT with more versus less contact with health professionals
Subjective change in symptoms
  • Women with UI:
    • Moderate quality evidence from 1 systematic review showed a clinically significant subjective improvement in UI symptoms with more contact compared to less contact with health professionals.
  • Women with SUI:
    • Very low to low quality evidence from 1 systematic review showed a clinically significant subjective improvement in SUI symptoms with more contact compared to less contact with health professionals.
Satisfaction with intervention, adherence to intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes.
Comparison 14. Group PFMT versus individual PFMT
Subjective change in symptoms
  • Women with UI:
    • Very low to low quality evidence from 1 systematic review showed a clinically significant subjective improvement in UI symptoms with group PFMT compared to individual PFMT.
  • Women with SUI/MUI:
    • Very low quality evidence from one RCT showed no difference in symptom severity between group PFMT compared individual PFMT.
Adherence to intervention
  • Women with UI:
    • Low quality evidence from 1 systematic review showed that women with UI were more likely to attend at least half of the supervised sessions with group PFMT than with individual PFMT.
Satisfaction with intervention
  • Women with SUI/MUI:
    • Low quality evidence from 1 RCT showed no difference in women’s satisfaction with group PFMT than with individual PFMT. Low quality evidence from another RCT showed no difference in terms of women’s perceived benefit with group PFMT compared to individual PFMT.
Anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes.
Comparison 15. Direct PFMT (for example voluntary pelvic floor muscle contraction) versus indirect PFMT (for example pelvic floor muscle contraction facilitated through abdominal muscle contraction)
Subjective change in symptoms
  • Women with UI:
    • Very low to low quality evidence from 1 systematic review showed no clinically significant difference in subjective UI symptoms with direct PFMT compared to indirect PFMT.
Adherence to intervention
  • Women with UI:
    • Low quality evidence from 1 systematic review showed that women with UI were more likely to attend at least half of the supervised sessions with direct PFMT than with indirect PFMT.
Satisfaction with intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes.
Comparison 16. Individualised PFMT versus generic PFMT
Subjective change in symptoms
  • Women with UI:
    • Very low to low quality evidence from 1 systematic review showed no clinically significant difference in subjective UI symptoms with individualised PFMT compared to generic PFMT.
Satisfaction with intervention, adherence to intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes.
Comparison 17. Daily PFMT versus PFMT 3 times per week
Subjective change in symptoms
  • Women with UI:
    • Very low to low quality evidence from 1 systematic review showed no clinically significant difference in subjective UI symptoms with daily PFMT compared to PFMT 3 times per week.
Satisfaction with intervention, adherence to intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes
Comparison 18. Upright and supine PFMT versus supine only PFMT
Subjective change in symptoms
  • Women with UI:
    • Very low to low quality evidence from 1 systematic review showed no clinically significant difference in subjective UI symptoms with upright & supine PFMT compared to supine only PFMT.
Satisfaction with intervention, adherence to intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes
Comparison 19. More intensive PFMT versus less intensive PFMT
Subjective change in symptoms
  • Women with UI:
    • Very low to moderate quality evidence from 1 systematic review showed a clinically significant improvement in subjective UI symptoms with more intensive PFMT compared to less intensive PFMT.
Satisfaction with intervention, adherence to intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes
Comparison 20: PFMT (app based) versus PFMT (written)
Subjective change in symptoms
  • Women with SUI/MUI:
    • Very low quality evidence from 1 RCT showed inconsistent evidence in terms of subjective change in symptoms between written PFMT and app-based PFMT.
Adherence to intervention
  • Women with SUI/MUI:
    • Very low to low quality evidence from 1 RCT showed a clinically important benefit of app-based PFMT when measured as the number of repetitions, and a possible clinically important benefit in terms of self-reported adherence, compared to written PFMT.
Satisfaction with intervention, anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes
Comparison 21: PFMT (outpatient) versus PFMT (home)
Subjective change in symptoms
  • Women with SUI:
    • Very low quality evidence from 1 RCT showed inconsistent evidence in terms of subjective change in symptoms between outpatient PFMT and home PFMT.
Adherence to intervention
  • Women with SUI:
    • Very low quality evidence from 1 RCT showed no difference between outpatient PFMT and home PFMT in terms of adherence.
Satisfaction with intervention
  • Women with SUI:
    • Very low quality evidence from 1 RCT showed a potential clinically important benefit of outpatient PFMT compared to home PFMT in terms of patient satisfaction.
Anxiety and depression and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes
Comparison 22. PFMT + biofeedback versus PFMT
Subjective change in symptoms
  • Women with SUI:
    • Very low to low quality evidence from 1 systematic review showed inconsistent findings about the benefit of PFMT and biofeedback in terms of quality of life when compared to PFMT alone.
    • Low quality evidence from 1 network meta-analysis showed no clinically important difference between PFMT + biofeedback compared to PFMT alone for quality of life.
    • Very low to low quality evidence from 1 systematic review however did show a clinically important benefit in terms of subjective change in symptoms with PFMT and biofeedback compared to PFMT alone.
  • Women with UI:
    • Moderate quality evidence from 1 systematic review showed inconsistent findings about the benefit of PFMT and biofeedback when compared to PFMT alone.
    • Very low to moderate quality evidence from 1 RCT showed no clinically important difference between PFMT + biofeedback and PFMT alone in terms of change in subjective symptoms.
  • Women with FI:
    • Very low to low quality evidence from 1 RCT showed inconsistent evidence, with the majority of evidence showing no clinically important difference between PFMT + biofeedback and PFMT in terms of change in symptoms, and 1 outcome showing a possible benefit of PFMT alone in terms of change in symptoms, and 1 outcome showing a possible benefit in terms of quality of life.
Adherence to intervention
  • Women with UI:
    • Very low to moderate quality evidence from 1 systematic review showed inconsistent findings about the benefit of PFMT and biofeedback in terms of adherence when compared to PFMT alone.
    • Moderate quality evidence from 1 RCT showed no clinically important difference between PFMT + biofeedback and PFMT alone in terms of adherence.
Anxiety and depression
  • Women with UI:
    • Low quality evidence from 1 systematic review showed no benefit of PFMT and biofeedback in terms of anxiety and depression when compared to PFMT
Satisfaction with intervention, and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes
Comparison 23. PFMT + feedback versus PFMT
Subjective change in symptoms
  • Women with UI:
    • Moderate quality evidence from 1 systematic review showed a clinically important benefit of PFMT and feedback when compared to PFMT alone.
Satisfaction with intervention
  • Women with UI:
    • Moderate quality evidence from 1 systematic review showed a clinically important benefit of PFMT and feedback when compared to PFMT alone.
Adherence to intervention, anxiety and depression, and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes
Comparison 24 PFMT + vaginal cones versus PFMT
Subjective change in symptoms
  • Women with SUI:
    • Very low to low quality evidence from 2 systematic reviews showed no clinically important difference between PFMT + vaginal cones and PFMT alone.
Adherence to intervention, anxiety and depression, and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes
Comparison 25. PFMT + electrical stimulation versus PFMT
Subjective change in symptoms
  • Women with SUI:
    • Very low to moderate quality evidence from 2 systematic reviews showed inconsistent findings about the benefits of PFMT + electrical stimulation when compared with PFMT alone for subjective SUI symptoms and quality of life.
    • Very low to moderate quality evidence from 1 RCT showed a clinically important benefit of PFMT + electrical stimulation in terms of quality of life, and a potential clinical important benefit in terms of recurrence of symptoms compared to PFMT alone.
  • Women with UI:
    • Low quality evidence from 1 RCT showed no clinically important difference between interventions in terms of subjective change in symptoms.
  • Women with FI:
    • Very low quality evidence showed no clinically important difference between interventions in terms of subjective change in symptoms, and a possible clinical benefit of PFMT + electrical stimulation in terms of quality of life.
Adherence to intervention, anxiety and depression, and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes
Comparison 26. PFMT (strength + motor learning) versus PFMT (motor learning only)
Subjective change in symptoms
  • Women with UI:
    • Very low to moderate quality evidence from 1 systematic review showed no clinically important difference between PFMT (strength and motor learning) when compared with PFMT (motor learning alone) for subjective UI symptoms and quality of life.
Adherence to intervention, anxiety and depression, and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes
Comparison 27. PFMT + abdominal exercise versus PFMT
Subjective change in symptoms
  • Women with UI:
    • Very low to low quality evidence from 1 systematic review showed no clinically important difference between PFMT + abdominal exercises and PFMT alone.
  • Women with SUI:
    • Low quality evidence from 1 RCT showed a clinically important benefit of PFMT + abdominal exercises in terms of subjective symptoms, compared to PFMT alone, whereas another RCT with moderate quality evidence showed no clinically important difference between interventions in terms of subjective change in symptoms.
  • Women with PFD (UI/POP/FI):
    • Low to moderate quality evidence showed no clinically important difference between interventions in terms of subjective change in symptoms.
Adherence to intervention
  • Women with PFD (UI/POP/FI):
    • Very low quality evidence showed no clinically important difference between interventions in terms of adherence.
Anxiety and depression, and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes
Comparison 28. PFMT + intravaginal device versus PFMT
Subjective change in symptoms
  • Women with UI:
    • Very low to low quality evidence from 1 systematic review showed no clinically important difference between PFMT + intravaginal devices and PFMT alone.
Adherence to intervention, anxiety and depression, and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes
Comparison 29. PFMT + adherence strategy versus PFMT
Subjective change in symptoms
  • Women with UI:
    • Very low quality evidence from 1 systematic review showed a clinically important benefit of PFMT + adherence strategy when compared to PFMT alone.
Adherence to intervention
  • Women with UI:
    • Low quality evidence from 1 systematic review showed a clinically important benefit of PFMT + adherence strategy when compared to PFMT alone.
Anxiety and depression, and adverse events leading to withdrawal/discontinuation
  • No evidence was identified to for these outcomes

The committee’s discussion of the evidence

Interpreting the evidence
The outcomes that matter most

As pelvic floor dysfunction is a complex, multi-factorial process the committee agreed that subjective improvement in the individual associated symptoms (urinary incontinence, emptying disorder of the bladder, emptying disorder of the bowel, faecal incontinence, sexual dysfunction, pelvic organ prolapse, pelvic pain) were the most appropriate critical outcomes for this review. Effective management of these symptoms should have a positive impact on quality of life – so this was also considered a critical outcome. Adherence to the intervention was also considered important as it can determine the success of an intervention. Satisfaction with the intervention and adverse events leading to discontinuation were also important outcomes due to their impact on the intervention’s acceptability. Anxiety and depression were also considered important outcomes because of the longer term impact of unmanaged pelvic floor dysfunction on mental health.

The quality of the evidence

The quality of the evidence for this review was assessed using GRADE and ranged from very low to moderate. In general, the evidence was downgraded for two reasons (i) concerns with the risk of bias, predominately selection of the reported results and (ii) the precision of the data, with either one or both of the confidence intervals crossing the line of no effect or passing default or published MIDs and reducing confidence in the true effect sizes.

While evidence was found for all the classes of interventions there was no evidence for any of the interventions in combination with Botox or Duloxetine. No evidence was found for the outcome adverse events leading to withdrawal or discontinuation.

Benefits and harms
Pelvic organ prolapse (POP)

Evidence from 1 systematic review suggested that PFMT improved symptoms of pelvic organ prolapse although 2 RCTs published since did not show consistent benefit. The committee noted these RCTs were in women in whom POP surgery was indicated and that they the women therefore had more severe symptoms which may respond less to pelvic floor muscle training. Therefore they were more confident about the findings synthesised in the included systematic review which came from many studies and included varying degrees of POP. The committee agreed that subjective measures are particularly important as they indicate the woman’s perception of success which can benefit their quality of life. An improvement was seen most in women with a prolapse that did not extend below the hymen (Stage I or II POP stage measured by the Pelvic Organ Prolapse Quantification (POP-Q)) so the recommendation was limited to this group.

The committee were conscious that follow-up was not consistent across the included studies, however agreed that in their experience a 4-month period was appropriate in order to review progress and treatment benefit. No evidence was found on the impact of pessaries with PFMT in women with symptoms of pelvic organ prolapse. The committee were aware from their clinical experience that PFMT may be used in combination with pessaries in women with pelvic organ prolapse. They agreed that a pessary may improve the effectiveness of PFMT due to the pessary offloading the prolapse from the pelvic floor muscles. Therefore, a research recommendation was made.

Stress urinary incontince or mixed urinary incontinence

The evidence (from both systematic reviews and RCTs published since) showed that PFMT was effective in improving symptoms of stress urinary incontinence. The committee acknowledged that two systematic reviews also showed that PFMT improved symptoms in women with mixed urinary incontinence and all types of urinary incontinence, but no evidence was identified for urgency urinary incontinence alone. Patient follow-up varied across the included studies, however the committee agreed that in their experience 3 months was a suitable time period.

Faecal incontinence

The evidence showed that PFMT was effective for women with pelvic organ prolapse and loose faecal incontinence or flatus leakage which supported the recommendation for PFMT in this group. The committee recommended at least 4 months for consistency with the other PFMT for pelvic organ prolapse recommendation There was uncertainty about the effect of PFMT on solid faecal incontinence as this is an uncommon symptom in women with pelvic organ prolapse so no recommendation was made for this group.

Group and individual training

One systematic review suggested that PFMT provided in a group setting or in combination with individual sessions improved symptoms of urinary incontinence and adherence to PFMT. The committee noted that an RCT published since the review did not find a benefit with group PFMT. Although the evidence was low in quality and inconsistent, it was in keeping with the committee’s experience in clinical practice that some women prefer the peer support of a group setting while others feel more motivated by one-to-one supervision. For this reason, they recommended a choice of group and individual PFMT training. The committee agreed that ongoing contact time with a health care professional improves adherence and the addition of peer support may improve this further.

Supervising pelvic floor muscle training and review

The evidence indicated that more contact with health professionals during PFMT was associated with better symptom improvement. The committee acknowledged that the included interventions were based on PFMT provided under direct supervision by a suitably trained health care professional with the appropriate expertise. They agreed that in their experience, increased benefit is seen with PFMT if an initial assessment of ability to contract as well as relax the pelvic floor muscles correctly is made with additional contact time following to review progress. This review should take place at least once during the programme to assess progress and once at the end). A review during development would also encourage adherence to the exercise programme. The committee noted that PFMT should be individualised to each woman to ensure the exercises are manageable as ability will differ based on other co-existing conditions. However, due a shift towards providing care virtually in light of the Covid-19 pandemic, a research recommendation about virtual supervision of PFMT was made to inform future guidance (see appendix L).

Supplementing PFMT

The evidence on the use of additional therapies such as weighted vaginal cones, biofeedback and electrical stimulation was inconsistent: some studies showed benefits, and others showed no effect. Some of the evidence suggested that these interventions could help women with pelvic floor muscle training by improving their ability to contract their pelvic floor muscles. In the committee’s experience, effective pelvic floor contractions are important for improving pelvic floor dysfunction symptoms and that most women are able to do this as part of a supervised pelvic floor muscle training programme. However, the committee believed that supplementing pelvic floor muscle training programme with biofeedback, electrical stimulation or vaginal cones, could be cost-effective in a subgroup who make little progress during supervised pelvic floor muscle training, especially if their use avoided the need for surgical intervention.

While in general the committee agreed that ability to perform pelvic floor muscle contraction correctly is more important than the load on the pelvic floor muscles, they acknowledged that in physically active women (such as athletes), increasing the load with intravaginal devices may be beneficial. Therefore, a research recommendation was made to investigate this further by using pessaries or weighted cones in combination with PFMT (see appendix L).

Continuing pelvic floor muscle training and follow-up

The evidence comparing more versus less PFMT suggested effectiveness was linked to the amount of PFMT done. Based on their experience, the committee thought it important that women are advised and encouraged at the end of the programme to continue doing pelvic floor muscle training and that they have the opportunity to discuss progress in regular reviews during the initial training programme.

Cost effectiveness and resource use

A Dutch economic evaluation (Panman 2017) compared PFMT with watchful waiting in women with pelvic organ prolapse. The committee noted that whilst providing some evidence for the cost-effectiveness of PFMT that the data was uncertain. They also agreed with the authors that generic quality-of-life scales might not adequately capture all changes in health related quality of life in a condition like prolapse. The committee also noted that this analysis was not directly applicable to a NHS setting.

The clinical review provided some evidence to suggest that PFMT was effective in improving the symptoms of pelvic organ prolapse, stress or mixed urinary incontinence and faecal incontinence. Whilst, the committee recognised that there was a cost to providing PFMT they also took into account that a beneficial programme of PFMT had the potential to delay or avert surgical alternatives to conservative management. Therefore, given the relatively low cost of PFMT the committee considered that it was likely to be cost-effective. The committee did not anticipate that their recommendations would have a significant resource impact as they reflect current best practice and are consistent with the NICE guideline on urinary incontinence and pelvic organ prolapse in women.

The committee believed that most women are able to perform effective pelvic floor muscle contraction through PFMT without the use of additional therapies and devices. However, the committee believed that. in the sub-group who are unable to perform an effective pelvic floor muscle contraction. additional therapies such as weighted vaginal cones, biofeedback and electrical stimulation would be likely to be cost-effective even if the evidence for their effectiveness was somewhat inconsistent. The committee reasoned that any positive contribution made by these additional therapies to the ability to perform pelvic floor contraction had the potential to avert subsequent expensive surgical intervention.

In the latest NHS National Cost Collection 2018/19 (https://www.england.nhs.uk/national-cost-collection/) , the cost of adult group physiotherapy provided by community health services is £54 as against £63 for one-to-one physiotherapy. The committee therefore recognised that PFMT provided with one-to-one supervision was costlier than group sessions. However, they also considered that there was some low quality and inconsistent evidence questioning the benefit of group PFMT. The committee considered that effectiveness of PFMT would be influenced by the woman’s preferences and they considered that whatever approach worked best for the woman was likely to be cost-effective and they made a recommendation which allowed for individual preference.

Other factors the committee took into account

In addition to the research evidence, the committee also took account of the Independent Medicine and Medical Devices Safety Review and the NHS Long Term Plan, which made recommendations on pelvic floor muscle training.

Recommendations supported by this evidence review

This evidence review supports recommendations 1.6.13 to 1.6.20 and also supports recommendations 1.3.15 and 1.3.16 which are supported by both this review as well as evidence review F (1.6.17 is only a cross reference to these). Two research recommendations were also supported by this review (1 on the effectiveness of pessary or intravaginal device combined with pelvic floor muscle training and 1 on virtual contact with a trainer, compared with in-person contact) in the NICE guideline.

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Appendices

Appendix J. Economic analysis

Economic evidence analysis for review question: What is the effectiveness of pelvic floor muscle training (including Kegel exercises, biofeedback, weighted vaginal cones, and electrical stimulation) for improving symptoms of pelvic floor dysfunction?

No economic analysis was conducted for this review question.

Appendix K. Excluded studies

Excluded studies for review question: What is the effectiveness of pelvic floor muscle training (including Kegel exercises, biofeedback, weighted vaginal cones, and electrical stimulation) for improving symptoms of pelvic floor dysfunction?

Economic studies

StudyReason for exclusion
Golmakani, N., Khadem, N., Arabipoor, A., Kerigh, B. F., Esmaily, H., Behavioral Intervention Program versus Vaginal Cones on Stress Urinary Incontinence and Related Quality of Life: A Randomized Clinical Trial, Oman Medical Journal, 29, 32–8, 2014 [PMC free article: PMC3910410] [PubMed: 24498480] Nothing on costs
Imamura,M., Abrams,P., Bain,C., Buckley,B., Cardozo,L., Cody,J., Cook,J., Eustice,S., Glazener,C., Grant,A., Hay-Smith,J., Hislop,J., Jenkinson,D., Kilonzo,M., Nabi,G., N’Dow,J., Pickard,R., Ternent,L., Wallace,S., Wardle,J., Zhu,S., Vale,L., Systematic review and economic modelling of the effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence, Health Technology Assessment, 14, 1–215, 2010 [PubMed: 20738930] All strategies include surgery
Jones, H. J. S., Gosselink, M. P., Fourie, S., Lindsey, I., Is group pelvic floor retraining as effective as individual treatment?, Colorectal Disease, 17, 515–521, 2015 [PubMed: 25524660] No Health economics
Sjostrom, M., Lindholm, L., Samuelsson, E., Mobile App for Treatment of Stress Urinary Incontinence: A Cost-Effectiveness Analysis, Journal of medical Internet research, 19, e154, 2017 [PMC free article: PMC5440735] [PubMed: 28483745] Societal perspective - majority of costs are participants time to complete PFMT

Final

Evidence review underpinning recommendations 1.6.13 to 1.6.20 (as well as 1.3.15 and 1.3.16) and 2 research recommendations in the NICE guideline

These evidence reviews were developed by the National Guideline Alliance which is a part of the Royal College of Obstetricians and Gynaecologists

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.

Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

Copyright © NICE 2021.
Bookshelf ID: NBK579544PMID: 35438881

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