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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
The present study is designed to be conducted as a prospective randomized controlled clinical trial (RCT) with three arms. 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. Traditional/classical treatment Group will follow PFM exercises program with the physiotherapist, which will take place in a health care environment. 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).

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

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Other: Pelvic floor muscle exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The sample consist Greek women, aged 18-75 years, with a diagnosis of urinary incontience (SUI or mixed UI). They should have undergone a urodynamic test by a medical doctor to detect the SUI. Women should be able to a) write and read Greek, b) use 'smart' phones and internet, c) to perform a voluntary muscle contraction of the PFM, during the clinical examination. Exclusion Criteria: Exclusion criteria include pregnant or up to 6 months postpartum, systemic diseases, malignancy, major gynecological surgery (i.e. total hysterectomy) over the last 10 years, neurological dysfunction, or mental impairment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-rehabilitation group<br>In the tele-rehabilitation group, participants will use a pelvic floor muscle (superficial) sensor, which will indicate the direction of the pelvic floor muscle (PFM) contraction in the collaborating mobile application. Patient and therapist could communicate either synchronously (i.e. through a video call) or asynchronously (information that stored in the application), regarding the execution of the PFM exercises (direction of the PFM contraction, frequency of the PFM program, duration, statistics etc.). So, the participants of the tele-rehabilitation group, will remotely perform a PFM exercises program at home by using a pelvic floor sensor and at the same time they self-manage their results through the mobile application, under the remote supervision of the physiotherapist. | Other: Pelvic floor muscle exercises<br>* 3 intervention arms (telerehabilitation, traditional physiotherapy and control) based on a progressive pelviic floor muscle exercise protocol will be used, including the same execise parameters (endurance, sntrength, positioning etc.) for all patients. However, exercise protocols will be individually presribed based on clinical assessment of PFMs by an experienced physiotherapist.<br>|
| Active Comparator: Traditional treatment group<br>In the Traditional (classic) treatment group, participants will follow the usual care treatment of PFMs, based on the pragmatic treatment of incontinence, which is used today in rehabilitation clinics, centers etc. The therapy will include face-to-face meetings weekly, between patient and physiotherapist regarding the progress of the treatment and its smooth transition (intra-vaginally assessment when it needs, correction, encouragement, motivation, etc.). In addition, the patients will be encouraged to do the same exercise program at home based on a printed leaflet that they will receive. | Other: Pelvic floor muscle exercises<br>* 3 intervention arms (telerehabilitation, traditional physiotherapy and control) based on a progressive pelviic floor muscle exercise protocol will be used, including the same execise parameters (endurance, sntrength, positioning etc.) for all patients. However, exercise protocols will be individually presribed based on clinical assessment of PFMs by an experienced physiotherapist.<br>|
| Other: Control group<br>Participants of the control group will be trained in PFM contraction in the 1st meeting assessment and they will receive a comprehensive leaflet, with instructions and PFM exercises at home. In addition, patients will be asked to follow the same PFM exercise protocol (frequency, type of contraction, etc.) as the other two groups at home on their own, without however guidance and supervision. | Other: Pelvic floor muscle exercises<br>* 3 intervention arms (telerehabilitation, traditional physiotherapy and control) based on a progressive pelviic floor muscle exercise protocol will be used, including the same execise parameters (endurance, sntrength, positioning etc.) for all patients. However, exercise protocols will be individually presribed based on clinical assessment of PFMs by an experienced physiotherapist.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF) | Patient-centered questionnaire which contains questions that assess the frequency, severity, and impact of incontinence on patients (total score 0-21). | At baseline (0 weeks), in the middle (6 weeks), and at the end of the intervention (12 weeks) | 
| 1-hour Pad test | Clinician-centered test by which, the pad is weighed before and after a set of specific-standardized exercises (walking, general exercises, etc.) during one hour. It is compared the difference in the amount of urine retained before and after the exercises in the pad, in order to de determined the urine leakage of the patient. | At baseline (0 weeks) and at the end of the intervention (12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PERFECT assessment scheme | Clinician-centered assessment which includes vaginal evaluation of the PFM contraction. The PERFECT assessment scheme, a well recognised and reliable measurement tool for PFMs evaluates a) the PFMs' power (via Modified Oxford scale) b) the PFMs' endurance in which is recorded the number of times that the maximum voluntary contraction held (up to 10 second), before a reduction of 50% or more (in power) is presented, c) the number of repetitions (up to 10) of the maximum voluntary PFM contraction, d) the number of fast PFM contractions (up to 10) with one second duration and one second relax, e) the elevation of the posterior vaginal wall , f) the co-contraction with other muscles (like lower abdominals) and g) the involuntary contraction of the PFM on coughing | At baseline (0 weeks), in the middle (6 weeks), and at the end of the intervention (12 weeks) | 
| Electromyographic (EMG) PFM's activity | Through a vaginal probe that detectes the PFM's electromyographic activity contraction in the screen of the software as feedback (Neutotrack) in the computer. By using the EMG probe, specific PFMs' parameters are evaluated (similar to the Perfect scheme, above), such as the PFMs' endurance, repetitions, fast PFM contractions and the involuntary contraction of the PFM on coughing. | At baseline (0 weeks), in the middle (6 weeks), and at the end of the intervention (12 weeks) | 
| Australian Pelvic Floor Questionnaire (APFQ) | patient-centered questionnaire which assesses 42 questions in 4 domains: bladder (1-15 question), bowel ( 16-27 question), pelvic organ prolapsed (28-32 question) and sexual function (33-42 question) | At baseline (0 weeks), and at the end of the intervention (12 weeks) | 
| Patient Global Impression of Improvement (PGI-I Scale) | Patient-centered questionnaire where patients rate the extent to which they believe they have improved (from 1 'much better' to 7 'much worse') | At the end of the intervention (12 weeks) | 
| Adherence questionnaire | Patient-centered questionnaire which contains 28 questions in total and the majority of them are closed type (yes/no). The 26 questions are based on the guidelines of the World Health Organization, are divided into the following sections: a) social and demographic factors (1 to 4 questions), b) Factors related to treatment (5 to 9 questions) c) questions about the health professionals and factors related to the health system -Physiotherapists (10 to 12 questions), d) patient related factors (13 to 23 questions) and e) Factors related to the patient's condition (24 to 26 questions). Question 27 is a 10-point scale of adherence, where patient self-assessed how well he followed the home exercise program (0-2 represent low adherence, 3-7 moderate adherence and 8-10 high adherence). Question 28 is an open-ended question about adherence to PFM exercises, where each patient responds to their reasons for their low or moderate adherence to the exercises. | At the middle (6 weeks), and at the end of the intervention (12 weeks) | 
| Daily exercise adherence diary | Patients fill in the diary during their treatment, in order to be evaluated by the researchers on how well patients followed the program | At baseline (provide the diary) and at the end of the intervention (12 weeks-measure adherence) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tele-rehabilitation, urinary incontinence, stress incontinence, pelvic floor muscle exercise, adherence