Clinical trial NCT06161324: Tele-rehabilitation for Women With Urinary Incontinence
Official title: The Effectiveness of a Tele-rehabilitation Program Implemented in a Greek Clinical Setting for Women With Urinary Incontinence: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Urinary Incontinence
Keywords: Tele-rehabilitation
urinary incontinence
stress incontinence
pelvic floor muscle exercise
adherence
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prevalence of urinary incontinence (UI) in the female Greek population is 1 to 3 women (27%).Globally, the development of tele-rehabilitation programs through mobile application (mobile apps) has been a breakthrough for UI treatment. More specifically, the pelvic floor muscles (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 choice (e.g their homes), with safety and less expense. Furthermore, it is given the opportunity to patients with mobility problems or with lack of transport or to them who live in remote areas, to treat their incontinence.

However, the majority of the existence mobile apps, work as simple verbal instructions and they do not being tailored in patients' individual needs, which is necessary for the successful implementation of the PFM exercise programs. Additionally, the PFM training is effective for UI treatment, when occurs intensively (daily) with supervision for at least 3 months by a physiotherapist. However, the adherence to a such intensive treatment program is very often compromised, because of many reasons (e.g lack of interest etc).

Therefore the main purpose of the current study is, to investigate the effectiveness of a tele-rehabilitation program, through a novel, innovative mobile app (customized in patients needs), in cooperation with a PFM superficial sensor. The mobile app will offer an interactive environment and the opportunity of a simultaneous supervision by a physiotherapist during the treatment, which might provide sufficient motivation to the patient to adhere with the intensive PFM exercise program. A secondary objective of the study is, to investigate the degree of adherence to PFM exercises and the degree of supervision, which is needed in the tele-rehabilitation program. Both the mobile app and the PFM superficial sensor, will be created for the needs of the present study.

Detailed description: The present study is designed to be conducted as a prospective randomized controlled clinical trial (RCT) with three arms.

1. The Telerehabilitation Group (TeleG) will use the mobile app in collaboration with the pelvic floor muscle (PFM) superficial sensor, with the remote supervision of the physiotherapist, which will take place in home.
2. Traditional treatment Group (TrG) will follow PFM exercises program with the physiotherapist, which will take place in a health care environment.
3. Control Group (CG) 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 (a) digital palpation using the PERFECT assessment scheme and through (b) an electromyography probe, in order to be assessed the power and the endurance of the PFMs. The patients will complete patient-centered outcome measures, such as a specific PFM exercise adherence questionnaire and a PFM 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 will be 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. The allocation of the participants to the different intervention groups (TeleG, TrG, and CG) will be carried out through a pre-specified computer-generated list, in blocks of six people. Each participant will be randomly assigned a number from the list via a sealed opaque envelope and then the participants will be randomly allocated to the intervention groups via a sealed opaque envelope. To achieve a uniform sample distribution in the intervention groups, each block will include two envelopes for each intervention group (e.g two envelopes for the TeleG, two for the TrG and two for the CG). This method ensures both randomization and concealed allocation, maintaining study integrity and unbiased sample allocation.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).

Eligibility criteria: Inclusion Criteria:

* Greek women,
* 18-75 years old,
* Diagnosis of SUI or mixed UI (via Urodynamic test).
* Writing and reading of the Greek language
* Usage of 'smartphones' and internet,
* Able to perform a voluntary muscle contraction of the PFM, during the clinical examination.

Exclusion Criteria:

* 6 months after postpartum,
* Systemic diseases,
* Malignancy,
* Major gynecological surgery (i.e. total hysterectomy) over the last 10 years,
* Neurological dysfunction,
* Mental impairment

Primary outcomes:
measure: International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF)
timeFrame: At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks)
measure: 1-hour Pad test
timeFrame: At baseline (0 week) and at the end of the intervention (12 weeks)
Secondary outcomes:
measure: PERFECT assessment scheme
timeFrame: At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks)
measure: Electromyographic (EMG) PFM's activity
timeFrame: At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks)
measure: Australian Pelvic Floor Questionnaire (APFQ)
timeFrame: At baseline (0 week), and at the end of the intervention (12 weeks)
measure: Patient Global Impression of Improvement (PGI-I Scale)
timeFrame: At the end of the intervention (12 weeks)
measure: Adherence questionnaire
timeFrame: At the middle (6 weeks), and at the end of the intervention (12 weeks)
measure: PFM adherence exercise diary
timeFrame: At baseline (0 week) is provided the PFM adherence exercise diary and the patients will return it, at the end (12 weeks) of the intervention
Other outcomes:
measure: 3-day bladder diary
timeFrame: At baseline (0 week) is provided the 3-day bladder diary and the patients will return it, after the 1st week
Locations:
city: Patras
country: Greece
facility: Laboratory of Clinical Rehabilitation and Research (CPRlab), University of Patras
state: Achaia
Study officials:
affiliation: University of Patras, Department of Physiotherapy
name: Evdokia Billis, PhD
role: STUDY_DIRECTOR
References:
citation: Papanikolaou DT, Lampropoulou S, Giannitsas K, Skoura A, Fousekis K, Billis E. Pelvic floor muscle training: Novel versus traditional remote rehabilitation methods. A systematic review and meta-analysis on their effectiveness for women with urinary incontinence. Neurourol Urodyn. 2023 Apr;42(4):856-874. doi: 10.1002/nau.25150. Epub 2023 Feb 18.