Telerehabilitation-Based versus Face-to-Face Pelvic Floor Muscle Training in Male Urinary Incontinence Following Radical Prostatectomy: A Randomized Clinical Trial

ATABEY GERLEGIZ E1, AKBAYRAK T1, GÜRSEN C1, MANGIR BOLAT N2, GÜLÖREN G1, ÇINAR G1, YAZICI M2, AKDOGAN B2, ÖZGÜL S1

Research Type

Clinical

Abstract Category

Rehabilitation

Abstract 18
Interventional Studies
Scientific Podium Short Oral Session 2
Wednesday 23rd October 2024
09:07 - 09:15
Hall N105
Stress Urinary Incontinence Male Quality of Life (QoL) Rehabilitation Conservative Treatment
1. Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Department of Fundamental Physiotherapy and Rehabilitation, Ankara, Turkey, 2. Hacettepe University, Faculty of Medicine, Department of Urology, Ankara, Turkey
Presenter
Links

Abstract

Hypothesis / aims of study
A majority of patients (up to 87%) experience moderate to severe urinary incontinence (UI) especially in the early period following radical prostatectomy (1). Pelvic floor muscle training (PFMT) is a strongly recommended conservative treatment in the first-line management of post-prostatectomy urinary incontinence (PP-UI).  However, before starting the PFMT program, it is very important to ensure that the patient can perform a correct pelvic floor muscle contraction (1). In PFMT, conscious precontraction of the pelvic floor muscles (Knack maneuver) should also be taught especially for the management of SUI. Another commonly recommended first-line approach is lifestyle modifications. It is recognized that follow-up and face-to-face visits in PFMT are very important to increase patients’ motivation and adherence to PFMT (2). However, telerehabilitation/telehealth applications have increased since the COVID-19 pandemic, and this trend is important in terms of time and cost-effectiveness (3). The aim of this study is to reveal the effects of telerehabilitation-based PFMT compared to face-to-face PFMT in a randomized clinical design. To the best of our knowledge, this is the first study comparing the face-to-face form of PFMT with the telerehabilitation-based PFMT in male incontinence.
Study design, materials and methods
The present study was designed as a prospective randomized clinical study with two parallel arms (Group I: PFMT with telerehabilitation-based follow-up, Group II: PFMT with face-to-face follow-up). After the detailed screening, individuals with PP-UI and those having no cooperation problems were included in the study. Exclusion criteria were the presence of acute disease, acute prostatectomy surgery (within the first 3 weeks after prostatectomy), neurological disease or neurogenic bladder, pure urgency UI, pre-operative incontinence, and previous bladder or other prostate surgeries. Based on randomized controlled trials in which the ICIQ-UI SF score was the primary outcome measure, the between-group effect size for the ICIQ-UI SF score was determined as d=0.9. In the two-way hypothesis test design, the sample size was calculated as 42 participants in total (21 participants per group), with 80% power and 5% type 1 margin of error. Considering a total 10% dropout rate, the final total sample size required was calculated as 48 individuals, with 24 individuals per study group.
 A computer-based block randomization procedure was used to assign participants to each study arm. After pelvic floor muscle contraction was confirmed digitally, both study groups received PFMT, Knack maneuver training, and lifestyle recommendations face-to-face in the first session. After this, individuals in Group 1 (n=19) were called by mobile phone every 2 weeks, explanations regarding all interventions were repeated and compliance was questioned. On the other hand, individuals in Group 2 were invited to clinical face-to-face visits every 2 weeks for the same purpose. The total intervention duration for both groups was 8 weeks. Participants were assessed twice, at baseline and at the end of week-8. The primary outcome measure was the subjective severity and impact of UI on daily life with the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI SF). Secondary outcome measures included the objective UI severity with 1-hour pad test and incontinence-specific quality of life with King's Health Questionnaire (KHQ). Individuals in both study groups also received printed exercise diaries to increase and monitor exercise compliance. The Wilcoxon test was used in the analysis of within-group changes and the Mann-Whitney -U test was used for the analysis of inter-group changes. Alpha was set at 0.05.
Results
A total of 43 participants were included in the study and 40 of them completed the study (age: 63,43±6,5 years, BMI: 26,93±3,41 kg/m2). There were no statistically significant differences between groups in terms of the descriptive and outcome measures at baseline (p>0.05). Adherence to PFMT was also similar between groups (p>0.05).
At the end of week-8, both study groups showed statistically significant improvements in the 1-hour pad test, ICIQ-UI SF score and scores of KHQ-incontinence impact, role limitations and physical limitations subdomains (p<0.05). However, Group II demonstrated significant improvements also in social limitation, personal relationships, emotional problems, and sleep/energy problems domains and severity measurement of the KHQ (p<0.05) (Table 1).
In the inter-group comparisons of the changes, Group II showed greater improvement in the 1-hour pad test, ICIQ-UI SF score, KHQ-incontinence impact, role limitations, physical limitations, and emotional problems subdomains. There were no statistical differences between groups in other domains of KHQ (p>0.05) (Table 1).
Interpretation of results
Both PFMT programs implemented face-to-face and telerehabilitation-based are effective in reducing the objective/subjective severity of incontinence and improving incontinence-related quality of life. However, compared to telerehabilitation-based training, face-to-face PFMT is superior for objective and subjective UI severity and multiple subdomains of quality of life.
Concluding message
In the management of PP-UI, the PFMT program with face-to-face follow-up reveals better results. However, telerehabilitation-based PFMT also plays an important role in achieving continence in individuals with various barriers (e.g. transportation, economic or pandemic barriers) to face-to-face PFMT. Future studies could compare the effects of different telerehabilitation options, such as video calls, and follow-up with mobile applications, or different PFMT parameters (including exercise intensity, frequency, duration, and call frequency). Further studies should also reveal long-term effects.
Figure 1 Table 1. Comparison of Primary and Secondary Outcome Measurements Within and Between Groups
References
  1. Anderson CA, Omar MI, Campbell SE, Hunter KF, Cody JD, Glazener CMA. Conservative management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev. 2015(1):251.
  2. Krzyzaniak N, Cardona M, Peiris R, Michaleff ZA, Greenwood H, Clark J, et al. Telerehabilitation versus face-to-face rehabilitation in the management of musculoskeletal conditions: a systematic review and meta-analysis. Physical Therapy Reviews. 2023:1-17.
  3. Muñoz-Tomás MT, Burillo-Lafuente M, Vicente-Parra A, Sanz-Rubio MC, Suarez-Serrano C, Marcén-Román Y, et al. Telerehabilitation as a therapeutic exercise tool versus face-to-face physiotherapy: a systematic Review. Int J Environ Res Public Health. 2023;20(5):4358.
Disclosures
Funding None Clinical Trial Yes Registration Number ClinicalTrials, NCT04804839 RCT No Subjects Human Ethics Committee Hacettepe University, Clinical Researches Ethics Boards, Number: KA-20081 Helsinki Yes Informed Consent Yes
Citation

Continence 12S (2024) 101360
DOI: 10.1016/j.cont.2024.101360

14/11/2024 00:23:48