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Meta-Analysis
. 2015 Nov 3;2015(11):CD010551.
doi: 10.1002/14651858.CD010551.pub3.

Pelvic floor muscle training added to another active treatment versus the same active treatment alone for urinary incontinence in women

Reuben Olugbenga Ayeleke  1 , E Jean C Hay-Smith, Muhammad Imran Omar
Affiliations
Meta-Analysis

Pelvic floor muscle training added to another active treatment versus the same active treatment alone for urinary incontinence in women

Reuben Olugbenga Ayeleke et al. Cochrane Database Syst Rev. .

Abstract

Background: Pelvic floor muscle training (PFMT) is a first-line conservative treatment for urinary incontinence in women. Other active treatments include: physical therapies (e.g. vaginal cones); behavioural therapies (e.g. bladder training); electrical or magnetic stimulation; mechanical devices (e.g. continence pessaries); drug therapies (e.g. anticholinergics (solifenacin, oxybutynin, etc.) and duloxetine); and surgical interventions including sling procedures and colposuspension. This systematic review evaluated the effects of adding PFMT to any other active treatment for urinary incontinence in women

Objectives: To compare the effects of pelvic floor muscle training combined with another active treatment versus the same active treatment alone in the management of women with urinary incontinence.

Search methods: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 5 May 2015), and CINAHL (January 1982 to 6 May 2015), and the reference lists of relevant articles.

Selection criteria: We included randomised or quasi-randomised trials with two or more arms, of women with clinical or urodynamic evidence of stress urinary incontinence, urgency urinary incontinence or mixed urinary incontinence. One arm of the trial included PFMT added to another active treatment; the other arm included the same active treatment alone.

Data collection and analysis: Two review authors independently assessed trials for eligibility and methodological quality and resolved any disagreement by discussion or consultation with a third party. We extracted and processed data in accordance with the Cochrane Handbook for Systematic Reviews of Interventions. Other potential sources of bias we incorporated into the 'Risk of bias' tables were ethical approval, conflict of interest and funding source.

Main results: Thirteen trials met the inclusion criteria, comprising women with stress urinary incontinence (SUI), urgency urinary incontinence (UUI) or mixed urinary incontinence (MUI); they compared PFMT added to another active treatment (585 women) with the same active treatment alone (579 women). The pre-specified comparisons were reported by single trials, except bladder training, which was reported by two trials, and electrical stimulation, which was reported by three trials. However, only two of the three trials reporting electrical stimulation could be pooled, as one of the trials did not report any relevant data. We considered the included trials to be at unclear risk of bias for most of the domains, predominantly due to the lack of adequate information in a number of trials. This affected our rating of the quality of evidence. The majority of the trials did not report the primary outcomes specified in the review (cure or improvement, quality of life) or measured the outcomes in different ways. Effect estimates from small, single trials across a number of comparisons were indeterminate for key outcomes relating to symptoms, and we rated the quality of evidence, using the GRADE approach, as either low or very low. More women reported cure or improvement of incontinence in two trials comparing PFMT added to electrical stimulation to electrical stimulation alone, in women with SUI, but this was not statistically significant (9/26 (35%) versus 5/30 (17%); risk ratio (RR) 2.06, 95% confidence interval (CI) 0.79 to 5.38). We judged the quality of the evidence to be very low. There was moderate-quality evidence from a single trial investigating women with SUI, UUI or MUI that a higher proportion of women who received a combination of PFMT and heat and steam generating sheet reported a cure compared to those who received the sheet alone: 19/37 (51%) versus 8/37 (22%) with a RR of 2.38, 95% CI 1.19 to 4.73). More women reported cure or improvement of incontinence in another trial comparing PFMT added to vaginal cones to vaginal cones alone, but this was not statistically significant (14/15 (93%) versus 14/19 (75%); RR 1.27, 95% CI 0.94 to 1.71). We judged the quality of the evidence to be very low. Only one trial evaluating PFMT when added to drug therapy provided information about adverse events (RR 0.84, 95% CI 0.45 to 1.60; very low-quality evidence).With regard to condition-specific quality of life, there were no statistically significant differences between women (with SUI, UUI or MUI) who received PFMT added to bladder training and those who received bladder training alone at three months after treatment, on either the Incontinence Impact Questionnaire-Revised scale (mean difference (MD) -5.90, 95% CI -35.53 to 23.73) or on the Urogenital Distress Inventory scale (MD -18.90, 95% CI -37.92 to 0.12). A similar pattern of results was observed between women with SUI who received PFMT plus either a continence pessary or duloxetine and those who received the continence pessary or duloxetine alone. In all these comparisons, the quality of the evidence for the reported critical outcomes ranged from moderate to very low.

Authors' conclusions: This systematic review found insufficient evidence to state whether or not there were additional effects by adding PFMT to other active treatments when compared with the same active treatment alone for urinary incontinence (SUI, UUI or MUI) in women. These results should be interpreted with caution as most of the comparisons were investigated in small, single trials. None of the trials in this review were large enough to provide reliable evidence. Also, none of the included trials reported data on adverse events associated with the PFMT regimen, thereby making it very difficult to evaluate the safety of PFMT.

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Conflict of interest statement

Reuben Olugbenga Ayeleke: None known

E. Jean C Hay‐Smith (JHS): None known

Muhammad Imran Omar: None known

Figures

1
1
PRISMA study flow diagram.
2
2
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
'Risk of bias' summary: review authors' judgements about each risk of bias domain for each included study.
1.1
1.1. Analysis
Comparison 1 PFMT added to vaginal cones versus vaginal cones alone, Outcome 1 Number of women cured or improved (objective assessment).
3.1
3.1. Analysis
Comparison 3 PFMT added to bladder training versus bladder training alone, Outcome 1 Number of women cured.
3.2
3.2. Analysis
Comparison 3 PFMT added to bladder training versus bladder training alone, Outcome 2 Number of women cured or improved.
3.3
3.3. Analysis
Comparison 3 PFMT added to bladder training versus bladder training alone, Outcome 3 Condition‐specific quality of life on IIQ‐R.
3.4
3.4. Analysis
Comparison 3 PFMT added to bladder training versus bladder training alone, Outcome 4 Condition‐specific quality of life on UDI.
3.5
3.5. Analysis
Comparison 3 PFMT added to bladder training versus bladder training alone, Outcome 5 Number of women cured or improved using patient global impression of improvement.
3.6
3.6. Analysis
Comparison 3 PFMT added to bladder training versus bladder training alone, Outcome 6 Incontinence episode per week.
3.7
3.7. Analysis
Comparison 3 PFMT added to bladder training versus bladder training alone, Outcome 7 Patient satisfaction with treatment outcome.
3.8
3.8. Analysis
Comparison 3 PFMT added to bladder training versus bladder training alone, Outcome 8 Number of women requiring further treatment (relapse).
4.1
4.1. Analysis
Comparison 4 PFMT added to electrical stimulation versus electrical stimulation alone (excluding implanted electrodes), Outcome 1 Number of women cured.
4.2
4.2. Analysis
Comparison 4 PFMT added to electrical stimulation versus electrical stimulation alone (excluding implanted electrodes), Outcome 2 Number of women cured or improved.
4.3
4.3. Analysis
Comparison 4 PFMT added to electrical stimulation versus electrical stimulation alone (excluding implanted electrodes), Outcome 3 Patient satisfaction with treatment outcome.
6.1
6.1. Analysis
Comparison 6 PFMT added to continence pessary versus continence pessary alone, Outcome 1 Number of women cured or improved.
6.2
6.2. Analysis
Comparison 6 PFMT added to continence pessary versus continence pessary alone, Outcome 2 Condition‐specific quality of life on UDI.
6.3
6.3. Analysis
Comparison 6 PFMT added to continence pessary versus continence pessary alone, Outcome 3 Number of women improved using patient global impression of improvement.
6.4
6.4. Analysis
Comparison 6 PFMT added to continence pessary versus continence pessary alone, Outcome 4 Patient satisfaction with treatment outcome.
7.1
7.1. Analysis
Comparison 7 PFMT added to drug therapy versus drug therapy alone, Outcome 1 Number of women cured.
7.2
7.2. Analysis
Comparison 7 PFMT added to drug therapy versus drug therapy alone, Outcome 2 Number of women cured or improved.
7.3
7.3. Analysis
Comparison 7 PFMT added to drug therapy versus drug therapy alone, Outcome 3 Condition‐specific quality of life on I‐QoL questionnaire.
7.4
7.4. Analysis
Comparison 7 PFMT added to drug therapy versus drug therapy alone, Outcome 4 Number of women improved on patient global impression of improvement in first 3 months.
7.5
7.5. Analysis
Comparison 7 PFMT added to drug therapy versus drug therapy alone, Outcome 5 Frequency of incontinence episodes per week in first 3 months.
7.6
7.6. Analysis
Comparison 7 PFMT added to drug therapy versus drug therapy alone, Outcome 6 Frequency of incontinence episodes per week at 12 months.
7.7
7.7. Analysis
Comparison 7 PFMT added to drug therapy versus drug therapy alone, Outcome 7 Frequency of micturitions per 24 hours.
7.8
7.8. Analysis
Comparison 7 PFMT added to drug therapy versus drug therapy alone, Outcome 8 Volumes of urine per micturition.
7.9
7.9. Analysis
Comparison 7 PFMT added to drug therapy versus drug therapy alone, Outcome 9 Number of continence pads used per week.
7.10
7.10. Analysis
Comparison 7 PFMT added to drug therapy versus drug therapy alone, Outcome 10 Treatment adverse events.
7.11
7.11. Analysis
Comparison 7 PFMT added to drug therapy versus drug therapy alone, Outcome 11 Patient satisfaction with treatment outcome in first 3 months.
7.12
7.12. Analysis
Comparison 7 PFMT added to drug therapy versus drug therapy alone, Outcome 12 Treatment benefit.
9.1
9.1. Analysis
Comparison 9 PFMT added to other treatment versus other treatment alone, Outcome 1 Number of women cured.
See this image and copyright information in PMC

Update of

References

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    1. Huang AJ, Thom DH, Kanaya AM, Wassel‐Fyr CL, Eeden SK, Ragins AI, et al. Urinary incontinence and pelvic floor dysfunction in Asian‐American women. American Journal of Obstetrics & Gynecology 2006;195(5):1331‐7. - PMC - PubMed
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Kafri 2007 {published data only}
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Kaya 2011 {published data only}
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    1. Kim H, Suzuki T, Yoshida Y, Yoshida H. Effectiveness of multidimensional exercises for the treatment of stress urinary incontinence in elderly community‐dwelling Japanese women: A randomized, controlled, crossover trial. Journal of the American Geriatrics Society 2007;55(12):1932‐9. - PubMed
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Kincade 2007 {published data only}
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Kobayashi 2009 {published data only}
    1. Kobayashi H, Sawada N, Zakohji H, Yoshiyama M, Araki I, Takeda M. Researches on the improvement of QOL in both patients with overactive bladder syndrome and their caregivers. Comparison between pharmacotherapy alone and combination of pharmacotherapy, physio‐therapy, and education of both patients and caregiver (Abstract number 516). Proceedings of the 39th Annual Meeting of the International Continence Society (ICS), 2009 Sep 29‐Oct 3, San Francisco, CA. 2009.
Lagro‐Janssen 1991 {published data only}
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Laycock 1988 {published data only}
    1. Laycock J. Interferential therapy in the treatment of genuine stress incontinence (Abstract). Neurourology & Urodynamics 1988;7(3):268‐9.
Laycock 1993 {published data only}
    1. Laycock J, Jerwood D. Does pre‐modulated interferential therapy cure genuine stress incontinence?. Physiotherapy 1993;79(8):553‐60.
Laycock 1995 {published data only}
    1. Laycock J, Knight S, Naylor D. Prospective, randomised, controlled clinical trial to compare acute and chronic electrical stimulation in combination therapy for GSI (Abstract). Neurourology & Urodynamics 1995;14(5):425‐6.
Laycock 2001 {published data only}
    1. Laycock J, Brown J, Cusack C, Green S, Jerwood D, Mann K, et al. A multi‐centre, prospective, randomised, controlled, group comparative study of the efficacy of vaginal cones and PFX (Abstract number 47). Neurourology & Urodynamics 1999;18(4):301‐2.
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Madersbacher 2003 {published data only}
    1. Madersbacher H, Pilloni S. Efficacy of extracorporeal magnetic innervation therapy (EXMI) in comparison to standard therapy for stress, urge and mixed incontinence: a randomised prospective trial (Abstract). Proceedings of the International Continence Society (ICS), 33rd Annual Meeting, 2003 Oct 5‐9, Florence Italy. 2003:296‐7.
Madersbacher 2004 {published data only}
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Maher 2009 {published data only}
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McCormack 2004 {published data only}
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Millard 2003b {published data only}
    1. Millard RJ. Clinical efficacy of tolterodine with or without a simplified pelvic floor exercise regimen (Abstract). Australia and New Zealand Journal of Surgery 2003;73:A337. - PubMed
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    1. Sultana A. Clinical evaluation of stress urinary incontinence in women of reproductive age and its management with combination of two Unani drugs. http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=6577 2014. [CTRI/2014/09/004997; sr‐incont64507]
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Zhao 2000 {published data only}
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