Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161324
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-16
First Post:
2023-11-29
Brief Title:
Tele-rehabilitation for Women With Urinary Incontinence
Sponsor:
University of Patras
Organization:
University of Patras
Study Overview
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The prevalence of urinary incontinence UI in the female Greek population is 1 to 3 women 27Globally 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 eg 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 eg 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
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 eg 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 REC of the University of Patras All patient data will be stored anonymouslycoded 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 eg 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 allocationDue 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 240 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 08 moderate if 05 and small if 02 Results will be considered statistically significant when p05 Finally the results will be presented in means M values and their standard deviations SD
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 REC of the University of Patras All patient data will be stored anonymouslycoded 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 eg 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 allocationDue 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 240 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 08 moderate if 05 and small if 02 Results will be considered statistically significant when p05 Finally the results will be presented in means M values and their standard deviations SD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None