FUNCTIONAL VERSUS TRADITIONAL PELVIC FLOOR MUSCLE TRAINING IN FEMALE STRESS URINARY INCONTINENCE: A RANDOMIZED CONTROLLED TRIAL

TOKMAK B1, AKBAYRAK T2, GÜRŞEN C2, ÖZGÜL N3, ÇİNAR G2, MANGIR BOLAT N4, ÖZGÜL S2

Research Type

Clinical

Abstract Category

Rehabilitation

Abstract 269
Female Pelvic Floor Dysfunction
Scientific Podium Short Oral Session 26
Friday 25th October 2024
14:00 - 14:07
Hall N106
Conservative Treatment Incontinence Pelvic Floor Clinical Trial Physiotherapy
1. Graduate School of Health Sciences, Master of Science Program in Physical Therapy and Rehabilitation, 2. Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Department of Physiotherapy and Rehabilitation, 3. Hacettepe University, Faculty of Medicine, Department of Obstetrics and Gynaecology, 4. Hacettepe University, Faculty of Medicine, Department of Urology
Presenter
Links

Abstract

Hypothesis / aims of study
Stress urinary incontinence (SUI) is a common and embarrassing condition that has a significant negative impact on patient’s psychosocial well-being. International guidelines recommend the use of pelvic floor muscle training (PFMT) as the first-line treatment for SUI (1). In addition, with the recent controversies regarding the use synthetic mesh in SUI surgery, there has been a revival of interest in non-surgical treatments. Functional training may be a good way to increase the effectiveness of PFMT, as various anatomical and functional relationships between the pelvic floor muscles and other muscle groups are noted in the literature. There are only two studies (2,3) addressing functional pelvic floor muscle training (F-PFMT) in men with UI after radical prostatectomy and in children with dysfunctional voiding, and in these studies, PFMT parameters, target muscle groups and exercises are different. The aim of this study was to assess the effects of F-PFMT compared to traditional PFMT (T-PFMT) in a randomized controlled design in women with SUI.
Study design, materials and methods
Women over 18 years of age with SUI or SUI-predominant mixed UI according to the “3 Incontinence Questionnaire” (3IQ) were included in the study. Exclusion criteria for the study were the presence of pure urgency UI, urgency-predominant mixed UI, neurogenic bladder, urinary tract infection or ≥ stage 2 pelvic organ prolapse, being pregnant or within 1 year of the postnatal period, having a history of abdomino-pelvic surgery or radiotherapy other than cesarean section, starting a new medication that would affect bladder functions within the last month and having pelvic floor muscle strength <2 according to the Modified Oxford Scale (MOS) on digital examination. Individuals included in the study were randomly assigned to one of 2 study groups by block randomization method (Intervention group: F-PFMT, Active control group: T-PFMT). In the first session, isolated pelvic floor muscle contraction was confirmed by vaginal palpation and one session of exercise was completed. The total PFMT period was 8 weeks and supervised PFMT checks were carried out in the clinic every 2 weeks. The number of pelvic floor muscle contractions was arranged to be equal in both groups.
In the F-PFMT (Group 1), functional exercises were given that activated the pelvic floor muscles and the muscles with myofascial and functional connections with pelvic floor (progressing from 90 daily functional exercises to 180 exercises simultaneously with pelvic floor muscle contraction). Supine marching, bridge, clamshell, cat-cow, squat and lunge exercises were chosen as functional exercises. In T-PFMT (Group 2-control group), maximal and submaximal isolated contractions were taught (progressing from 90 contractions to 180 contractions per day).
The primary outcome measure of the study was the subjective severity and impact of UI determined by the International Incontinence Consultation Questionnaire-Short Form. Secondary outcome measures were pelvic floor muscle strength based on the MOS, objective UI severity using the 1-hour pad test, and levels of subdomains of incontinence-specific quality of life (QoL) using the King’s Health Questionnaire (KHQ). Individuals were evaluated in three separate periods: before the PFMT, and at the end of the 4th and 8th weeks of PFMT. Exercise diaries were used for individuals' motivation and compliance with the PFMT, and the final compliance level was calculated as a percentage.
Based on the study comparing the effects of pre-operative standard PFMT and F-PFMT on UI after RP, a mean difference of 3.67 units was taken as the basis for the significant difference between the groups in the change in total ICIQ-UI SF scores (2). In the two-way hypothesis design, the total sample size was calculated as at least 40 individuals (20 individuals per group), with a 5% type 1 error margin, 80% power, a calculated effect size of d = 1.04 and a 20% drop-out rate.
The time-dependent change of numerical data within the group was analyzed with the Friedman test, and if there was a difference, the post-hoc Conover test was used. Independent groups t-test or Mann-Whitney U test was used for intergroup comparisons of numerical data. Relationships between categorical variables were evaluated with the Fisher-Freeman-Halton exact test. Statistical significance level was accepted as p ≤ 0.05 and clinical significance level as p <0.10.
Results
50 women diagnosed with SUI were included in the study (age: 53.80±11.74 years; BMI: 27.85±3.84 kg/m2), but 41 of them completed the study (F-PFMT, n=20; T-PFMT, n=21). Descriptive and outcome measures of the study groups were similar at baseline (p>0.05).
There were statistically (p<0.05) or clinically significant (p<0.10) improvements compared to baseline in all outcome measures except the general health perception subdomain of the KHQ in both intervention groups.
In the intergroup comparisons of the 4th week and 8th week measurements, pelvic floor muscle strength was higher and objective incontinence severity was lower in the F-PFMT group compared to the T-PFMTgroup (p<0.05). On the other hand, it was found that there was no difference between the groups in terms of ICIQ-UI SF and KHQ scores.
Interpretation of results
F-PFMT appears to be more effective than T-PFMT in improving pelvic floor muscle strength and objective UI severity. However, F-PFMT and T-PFMT improve subjective UI severity, the impact of UI on daily life, and sub-domains of incontinence-specific QoL at a similar level.  To the best of our knowledge, this is the first study to adress F-PFMT in female SUI and to report good or better results compared to T-PFMT.
Concluding message
In the management of female SUI, F-PFMT should be considered as an alternative, effective and more dynamic method to T-PFMT, especially in group training. Additionally, two types of training can be carried out in combination. Patient characteristics and preferences should also be considered in deciding on the type of training. Further studies should reveal the long-term effects of these trainings.
Figure 1 Table 1. Within- and between-group comparisons of main outcome measures
References
  1. Ptak M, Brodowska A, Ciecwiez S, Rotter I. Quality of Life in Women with Stage 1 Stress Urinary Incontinence after Application of Conservative Treatment-A Randomized Trial. International Journal of Environmental Research and Public Health. 2017;14(6).
  2. Sayner A, Nahon I, Davies S, Haines K, Karahalios E, Ogluszko C. Pre-operative functional pelvic floor muscle training in radical prostatectomy: identifying feasibility. BJU International Supplement. 2018;122(S2):20-1.
  3. Ladi Seyedian SS, Sharifi-Rad L, Ebadi M, Kajbafzadeh AM. Combined functional pelvic floor muscle exercises with Swiss ball and urotherapy for management of dysfunctional voiding in children: a randomized clinical trial. Eur J Pediatr. 2014;173(10):1347-53.
Disclosures
Funding None Clinical Trial Yes Registration Number Clinical Trials.gov, Registration Number: NCT05293886 RCT Yes Subjects Human Ethics Committee Hacettepe University, Clinical Researches Ethics Boards, Registration Number: KA-21107 Helsinki Yes Informed Consent Yes
Citation

Continence 12S (2024) 101611
DOI: 10.1016/j.cont.2024.101611

19/11/2024 17:48:08