Tele-rehabilitation for Women With Urinary Incontinence: A Randomized Controlled Trial

Urinary Incontinence Clinical Trial

Official title: The Effectiveness of a Tele-rehabilitation Program Implemented in a Greek Clinical Setting for Women With Urinary Incontinence: A Randomized Controlled Trial

Status Enrolling by invitation

Clinical Trial Summary

We are conducting a study in Greece, where the prevalence of urinary incontinence (UI) in the female Greek population is 1 to 3 women (27%) . PFM training is effective for UI treatment, when occurs intensively (daily), with physiotherapy supervision for at least 3 months. However, adhearance to such intense treatment is very often compromised. We therefore believe that a telerehabilitation programme, such as a mobile application (app) in collaboration with a pelvic floor muscle sensor and with the simultaneous supervision of the physiotherapist (via the mobile app), will provide sufficient motivation for the patient to adhere with daily exercises. The development of tele-rehabilitation programs through mobile applications (mobile apps) has been a breakthrough for UI treatment. The pelvic floor muscle (PFM) exercise programs through mobile apps, provide optimal health care services by offering to the patients a therapy program in the convenient environment of their homes, with safety and less expense. Moreover, the majority of the existence mobile apps, work as simple verbal instructions, do not being tailored in patients' individual needs, and they are not able to assess the right direction of PFM contraction (inwardly and towards the navel), which is necessary for the successful implementation of the PFM exercises. Therefore the main purpose of the study is to investigate the effectiveness of a tele-rehabilitation program, through a novel, innovative mobile app in cooperation with a pelvic floor muscle sensor, indicating the direction of the PFM contraction in real time, which might be effective in UI treatment. The mobile app as well as the pelvic floor sensor will be created for the needs of the present study. A secondary objective of the study will be to investigate the degree of adherence to PFM exercises and the degree of supervision, which needs in the tele-rehabilitation program. The present study is designed to be conducted as a prospective randomized controlled clinical trial (RCT) with three arms. We believe that the contribution of the current research has a social and economic impact on the life of the Greek woman with incontinence and this lies in the fact that, it is a fast, easy-to-use, modern approach opening new horizons in the field of rehabilitation. In addition, the patient maintains her interest in the exercises, performs them safely, more economically in her own time and in a familiar environment of her choice. Finally, rehabilitation through the mobile app in cooperation with the pelvic floor transperineal sensor is an extremely useful clinical "tool" for Physiotherapists and patients, giving the opportunity to patients with mobility problems or with lack of transport or to them who live in remote areas, to treat their incontinence.

Clinical Trial Description

The present study is designed to be conducted as a prospective randomized controlled clinical trial (RCT) with three arms. 1. The Telerehabilitation Group will use the mobile app in collaboration with the pelvic floor sensor with the remote supervision of the physiotherapist which will take place in patient's home. 2. Traditional/classical treatment Group will follow PFM exercises program with the physiotherapist, which will take place in a health care environment. 3. Control Group will execute the PFM exercises via a home leaflet, without any supervision. Αll patients will be assessed in three sessions, at baseline (0 wk), half-way at 6 wks and at the end of the treatment (after 12 wks. Primary outcome measures will evaluate the severity of the incontinence and the quantity of the urinary loss through the patient-centered International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF) and the clinician-centered '1-hour Pad test', respectively. Secondary outcomes will include vaginal evaluation through digital palpation using the PERFECT assessment scheme and through an electromyography probe, in order to assess the power and the endurance of the PFMs. The patients will complete patient-centered outcome measures, such as specific pelvicl floor exercise adherence questionnaire and exercise diary during their treatment, in order to be evaluated on how well they followed the program. Patients will be recruited voluntarily through the University Urology clinic, physician referrals, advertisements in hospitals, posting on the internet, social networks (facebook), etc. Once eligible patients have been selected for treatment, they will fill out an informed consent form. This study adheres to Ethical considerations and the Helsinki Declaration and is approved by the Research Ethics Committee (R.E.C.) of the University of Patras. All patient data are stored anonymously/coded in a secure cloud platform accessed only by the research team members. Imputation methods will be applied to address situations where variables are missing, uninterpretable, or inconsistent. Any adverse events will be addressed and documented, while medical consultation will be accessible if needed. To be ensured the complete allocation concealment of the groups, a randomization process will be used, by a 'blind' researcher who will have no knowledge of the assessment and treatment procedures. Due to the nature of the treatment, the intervention is not blinded between participants and clinicians. However, the analysis of the data will be 'blind' (blind-assessor) It will be performed an analysis based on the data resulting from the initial grouping of patients by treatment protocol (intention-to-treat analysis). The data will be collected in excel tables and through SPSS version 24.0 for Windows and a statistical analysis will be performed. Comparison within the groups before and after the intervention will be performed by ANOVA using repeated measurements. Comparison between groups after the intervention will be performed by the Student t-test (independent measurements); while the chi-square test will be used for categorical variables (eg yes, no, etc.). In addition, we will calculate the effect size with 95% confidence intervals for each outcome measure with continuous variables. Effect sizes will be considered large if ≥0.8, moderate if ≥0.5 and small if ≥0.2. Results will be considered statistically significant when p<.05. Finally, the results will be presented in means (M) values and their standard deviations (SD). ;

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

• NCT number: NCT06161324
• Study type: Interventional
• Source: University of Patras
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2023
• Completion date: December 31, 2024