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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06161324
• Other study ID #: Telerehab and incontinence
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: November 25, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Other:
• Pelvic floor muscle exercises
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.

Locations

Country	Name	City	State
Greece	Laboratory of Clinical Rehabilitation and Research (CPRlab), University of Patras	Patras	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)