Luginbuehl et al. Trials (2015) 16:524 DOI 10.1186/s13063-015-1051-0
STUDY PROTOCOL
TRIALS Open Access
Involuntary reflexive pelvic floor muscle training in addition to standard training versus standard training alone for women with stress urinary incontinence: study protocol for a randomized controlled trial Helena Luginbuehl1,2*, Corinne Lehmann3, Jean-Pierre Baeyens2, Annette Kuhn4 and Lorenz Radlinger1
Abstract Background: Pelvic floor muscle training is effective and recommended as first-line therapy for female patients with stress urinary incontinence. However, standard pelvic floor physiotherapy concentrates on voluntary contractions even though the situations provoking stress urinary incontinence (for example, sneezing, coughing, running) require involuntary fast reflexive pelvic floor muscle contractions. Training procedures for involuntary reflexive muscle contractions are widely implemented in rehabilitation and sports but not yet in pelvic floor rehabilitation. Therefore, the research group developed a training protocol including standard physiotherapy and in addition focused on involuntary reflexive pelvic floor muscle contractions. Methods/design: The aim of the planned study is to compare this newly developed physiotherapy program (experimental group) and the standard physiotherapy program (control group) regarding their effect on stress urinary incontinence. 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), and — regarding secondary and tertiary outcomes — higher pelvic floor muscle activity during stress urinary incontinence provoking activities, better padtest results, higher quality of life scores (International Consultation on Incontinence Modular Questionnaire) and higher intravaginal muscle strength (digitally tested) from before to after the intervention phase. This study is designed as a prospective, triple-blinded (participant, investigator, outcome assessor), randomized controlled trial with two physiotherapy intervention groups with a 6-month follow-up including 48 stress urinary incontinent women per group. For both groups the intervention will last 16 weeks and will include 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 (3x/week, 1x/day) until the 6-month follow-up. To compare the primary outcome, International Consultation on Incontinence Modular Questionnaire (short form) 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. (Continued on next page)
* Correspondence:
[email protected] 1 Bern University of Applied Sciences, Health, Discipline of Physiotherapy, Bern, Switzerland 2 Vrije Universiteit Brussel, Faculty of Physical Education and Physiotherapy, Brussels, Belgium Full list of author information is available at the end of the article © 2015 Luginbuehl et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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Discussion: This study closes a gap, as involuntary reflexive pelvic floor muscle training has not yet been included in stress urinary incontinence physiotherapy, and if shown successful could be implemented in clinical practice immediately. Trial registration: NCT02318251; 4 December 2014 First patient randomized: 11 March 2015 Keywords: Electromyography, Exercise, Muscle contraction, Pelvic floor, Reflex
Background Stress urinary incontinence (SUI), the most common urinary incontinence subtype in women with a prevalence of 24.8 % [1], is defined as involuntary loss of urine during effort or physical exertion (for example, during sporting activities) or upon sneezing or coughing [2]. Activities typically provoking SUI raise the intra-abdominal pressure and impact loading on the pelvic floor muscles (PFM) and require strong, rapid, and reflexive PFM contractions to maintain continence [3–6]. Fast and strong PFM contractions result in the generation of an adequate squeeze pressure in the proximal urethra, which maintains a pressure higher than that in the bladder, thus preventing leakage [7]. PFM function regarding power (rate of force development) is impaired in incontinent women compared to continent women [4, 6]. PFM training — defined as a program of repeated voluntary PFM contractions taught and supervised by a health care professional — is the most commonly used physiotherapy treatment for women with SUI, is effective with all types of female incontinence, and, therefore, is recommended as a first-line therapy [8, 9]. As endorsed by the International Consultation on Incontinence, PFM training should generally be the first step of treatment before surgery [10]. However, standard SUI physiotherapy concentrates on voluntary contractions even though the situations provoking SUI such as sneezing, coughing, jumping, and running [2] require involuntary fast reflexive PFM contractions [4]. Although training procedures following the concepts of training science and sports medicine are generally well known and widely implemented in rehabilitation and sports [11, 12], an optimal and well-standardized training protocol for involuntary, fast, and reflexive PFM contractions still remains unknown. Consequently, the research group of the present study developed a standardized therapy program, which includes the standard physiotherapy and additionally focuses on involuntary fast reflexive PFM contractions. The additional exercises are well known and applied in physiotherapy, however not yet regarding SUI. Therefore, the aim of the present study is to compare two different physiotherapy programs: standard training
plus involuntary reflexive PFM training versus standard training alone, regarding their effect on SUI and the impact of incontinence symptoms on quality of life. Both programs include standard physiotherapy. Both follow the concepts of training science, that is, periodization/ exercise sequence and training of specific muscle strength components [11, 12]. One program focuses on voluntary fast contractions (standard physiotherapy; control group); the other one additionally focuses on involuntary fast reflexive PFM contractions (experimental group). The secondary objective, based on secondary and tertiary outcomes, is a deeper insight into the functioning of the PFM (PFM activity characteristics and muscle action forms) by evaluating their activity measured by electromyography (EMG) in the quality of life of patients with SUI and in patients’ therapy adherence.
Methods/design Study design
The present study is a single-centered, prospective, tripleblinded (participant, investigator, outcome assessor), parallel group, non-inferiority randomized controlled trial with two physiotherapy intervention groups with a 6month follow-up. Blinding
Participants will be blinded against the type of received physiotherapy (control group, experimental group). The participant information document will not provide any information regarding the differences in the experimental and control therapy protocols in a way that women could find out about their group allocation. All investigators involved in data acquisition, data reduction, data analyses, and statistics will also be blinded against group allocation. The physiotherapists in charge of the therapy cannot be blinded against group allocation and therefore will not be involved in data acquisition, data reduction, data analyses, or statistics. Participants
With ethics committee approval (Ethics Committee of the Canton of Bern reference number 249/14 on 12 November 2014; Chairperson Prof. Dr. Ch. Seiler), which is
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in accordance with the Declaration of Helsinki and the Swiss Human Research Act, and written informed consent, patients will be included on the condition that they are female adults aged 18–70 years, suffer from SUI (based on the patient’s history) or mixed urinary incontinence (with dominant SUI), are one year post-partal, parous, nulliparous, pre- or post-menopausal, have a BMI of 18–30 kg/m2, are medically and physically fit for the measurement and therapeutic exercises (running, jumps), and, in case of systemic or local estrogen treatment, stable for the past 3 months prior to inclusion. Exclusion criteria are: urge incontinence or predominant urgency in incontinence; prolapse > grade 1 POP-Q [13] (uterus, cystocele, rectocele during Valsalva maneuver); pregnancy (urine test to accomplish); current urinary tract or vaginal infection, menstruation on the day of examination; lactation period not yet finished; contraindications for measurements or interventions, for example, acute inflammatory or infectious disease, tumor, fracture; de novo systemic or local estrogen treatment (
