INVOLUNTARY REFLEXIVE VERSUS VOLUNTARY PELVIC FLOOR MUSCLE TRAINING FOR STRESS URINARY INCONTINENCE TREATMENT: A RANDOMIZED CONTROLLED TRIAL

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H. Luginbuehl1, C. Lehmann2, I. Koenig1,3, A. Kuhn4, R. Buergin5, L. Radlinger1
1Bern University of Applied Sciences, Department of Health Professions, Division of Physiotherapy, Bern, Switzerland, 2Bern University Hospital and University of Bern, Department of Physiotherapy, Bern, Switzerland, 3Vrije Universiteit Brussel, Faculty of Physical Education and Physiotherapy, Brussels, Belgium, 4Bern University Hospital and University of Bern, Women’s Hospital, Urogynaecology, Bern, Switzerland, 5Bern University of Applied Sciences, Department of Health Professions, Division of Nursing, Bern, Switzerland

Background: To date pelvic floor muscle (PFM) training is described as based on voluntary PFM contractions even though involuntary reflexive PFM contractions seem crucial during stress urinary incontinence (SUI) provoking situations. Training procedures for involuntary reflexive muscle contractions are widely implemented in rehabilitation and sports but not yet in PFM rehabilitation. Therefore, we developed two PFM training protocols, one including standard physiotherapy (PT) and one additionally focusing on involuntary reflexive PFM contractions.

Purpose: The study aim was to compare the two PT protocols regarding their effect on SUI.

Methods: This study was designed as a prospective triple-blind randomized controlled trial with two PT intervention groups: CON = control group (standard PT), EXP = experimental group (standard PT + involuntary reflexive PFMT). The primary outcome was the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence short form. This trial was registered (NCT02318251) and the study protocol published in Trials. Forty-eight women were included per group.
To analyze group differences (CON vs. EXP) and the development over time, mixed effect regression models were used, which allow to account for within-participant correlations by random effects.

Results: The analysis of intervention effects revealed that the total score of the primary outcome decreased significantly over time (pre/post) by about 3 points for both groups (EXP: 10.3/7.4; CON: 10.0/7.0), however, did not differ between groups.

Conclusion(s): This study showed clinically relevant improvements in SUI in the CON as well as in the EXP group. However, there was still moderate SUI present in both groups after the intervention. These results are comparable to pre/post differences in former physiotherapy intervention studies. A possible reason for not complete SUI cure could be that relevant training methods (hypertrophy training, intramuscular coordination, power and power endurance training) cannot be applied on the PFM as easily as on other skeletal muscles (e.g. no external weights).
The following aspects could additionally have impaired the outcome of the present study: Compared to a common phase duration of skeletal muscle training methods, the training methods were applied during rather short time phases because of feasibility reasons regarding a pragmatic clinical trial approach; furthermore, therapy method phases were terminated without assessing obtainment of the related therapy methods’ effects. Due to scientific requirements of a strict standardization of a training protocol, the used standardization, as necessary in RCTs, did prohibit adaptation of training parameters to individual factors and progress status.

Implications: Future studies should use criteria oriented and not time-oriented PFM training protocols, i.e. individualized PFM training protocols and progress. Therefore, criteria for goal obtainment of each PFM training method phase would have to be developed and defined. 
Furthermore, training methods for PFM hypertrophy, intramuscular coordination, power and power endurance training performed with higher intensities and workout should be developed and tested.
This study confirms the new approach of applying SUI provoking activities as specific training stimuli of involuntary reflexive PFMT as a feasible and safe approach for SUI treatment. Furthermore, it proved as effective as conventional PFMT and still shows potential for further development i.e. improvement.

Funding, acknowledgements: This study was funded by the Swiss National Science Foundation, Division III (Medicine & Biology; 320030_153424/1)

Keywords: Exercise, Muscle contraction, Physical Therapy Modalities

Topic: Pelvic, sexual and reproductive health

Did this work require ethics approval? Yes
Institution: Bern University Hospital
Committee: Ethics Committee of the Canton of Bern
Ethics number: 249/14


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