INVOLUNTARY REFLEXIVE VERSUS STANDARD VOLUNTARY PELVIC FLOOR MUSCLE TRAINING: RCT PROTOCOL TESTING A NEW THERAPY CONCEPT FOR STRESS URINARY INCONTINENCE

Luginbuehl H.^1,2, Lehmann C.³, Baeyens J.-P.², Kuhn A.⁴, Koenig I.¹, Radlinger L.¹

¹Bern University of Applied Sciences, Health, Bern, Switzerland, ²Vriije Universiteit Brussel, Brussel, Belgium, ³Department of Physiotherapy, Bern University Hospital and University of Bern, Bern, Switzerland, ⁴Women's Hospital, Urogynaecology, Bern University Hospital and University of Bern, Bern, Switzerland

Background: Pelvic floor muscle (PFM) training is effective and recommended as first-line therapy for female patients with stress urinary incontinence (SUI). However, standard PFM physiotherapy concentrates on voluntary contractions although the situations provoking SUI require involuntary fast reflexive PFM contractions. To date, the focus of research on PFM function has been on the concentric and isometric muscle action leading to the lift and squeeze but so far no light has been shed on the eccentric or eccentric-concentric type of contraction and the related involuntary or reflexive power. Such training procedures are widely implemented in rehabilitation and sports but not yet in pelvic floor rehabilitation.

Purpose: Therefore, the aim of this study was to develop a training protocol including standard physiotherapy and in addition focusing on involuntary reflexive pelvic floor muscle contractions and to prepare a RCT study protocol comparing this newly developed physiotherapy program (experimental group) and the standard physiotherapy program (control group) regarding their effect on female SUI.

Methods: The PFM training protocol follows the progression of training for motor learning, strength, hypertrophy and power training phases according to the training principles variation/ periodization, muscle action and velocity of muscle action, loading, volume, exercise selection, rest periods and frequency for both groups. The intervention lasts 16 weeks including 9 personal physiotherapy consultations and 78 short home training sessions (weeks 1-5 3x/week, 3x/day; weeks 6-16 3x/week, 1x/day). Thereafter both groups will continue with home training sessions for 6 months. The working hypothesis is that the experimental group focusing on involuntary reflexive muscle contractions will have a higher improvement of continence measured by the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence (short form) (ICIQsf), and, regarding secondary and tertiary outcomes, higher electromyography PFM activity during SUI provoking activities (running at different speeds, squat jump, countermovement jump, drop jump), better pad-test results, higher quality of life scores (International Consultation on Incontinence Modular Questionnaire (ICIQLUTsquol) and higher intravaginal muscle strength (digitally tested) from before to after intervention phase. This study is designed as a prospective, triple-blinded, RCT with two physiotherapy intervention groups with a 6-month follow-up including 48 stress urinary incontinent women per group. To compare the primary outcome, ICIQsf between and within the two groups at ten time points (before intervention, physiotherapy sessions 2–9, after intervention) ANOVA models for longitudinal data will be applied.

Results: The RCT study protocol for testing involuntary reflexive versus standard voluntary PFM training was registered (NCT02318251) and received ethics committee approval (Ethics Committee of the Canton of Bern reference number 249/14) with the first participant included in March 2015.

Conclusion(s): This study closes a gap, as it presents a novel SUI therapy regimen including involuntary reflexive PFM training.

Implications: The current guidelines for physical therapy in patients with SUI do not contain PFM involuntary reflex training. Consequently, should this therapy protocol including involuntary reflexive PFM training in addition to standard training prove more effective than standard training alone, this would be of high clinical and practical relevance and implementation could follow immediately.

Funding acknowledgements: Funded by: Swiss National Science Foundation (SNSF; (320030_153424/1). The granting SNSF is not involved in the study protocol and conduct.

Topic: Women's & men’s pelvic health

Ethics approval: Ethics approval: Ethics Committee of the Canton of Bern Switzerland, reference number 249/14; 12 November 2014; Chairperson Prof. Dr. Seiler

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