- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04518683
Rehabilitation With Mobile Applications in Women With SUI (SUI)
Evaluation of a New Treatment Using Mobile Applications in the Treatment of Stress Urinary Incontinence in Women Outside the Peripartum - Pilot Study
Study Overview
Status
Conditions
Detailed Description
The quantitative component is composed of 2 arms and the intervention is during 3 months:
- Study group : half of the participants will have a home pelvic floor work program via a mobile application in addition to therapeutic follow-up by a physiotherapist.
- Control group: the other half will perform the home pelvic floor work program without application and will also have therapeutic follow-up by a physiotherapist.
The qualitative component will include individual and semi-structured interviews based on an interview guide with 4 women in the study group and 4 women in the other group after completion of their perineal rehabilitation program.
The protocol will be offered to patients who meet the inclusion criteria (see below). Participants will be randomized into one of the two groups using sealed opaque envelopes, the order of which will have been randomly generated by randomization software.
Recruitment of participants will be done with the help of partner doctors. They will be responsible for introducing them to the study and providing them with the necessary documentation (information and informed consent sheets, 9 physiotherapy sessions for the treatment of SUI and the list of physiotherapists from the ASPUG-PP adapted to the study). The physiotherapists included in this study are all specialized in pelvi-perineology and members of ASPUG-PP and trained in the study protocol. They will ensure running of the process by collecting information from the anamnesis and carrying out pre- and post-tests with the project team.
The data will be entered directly by the investigator or one of the collaborators in Redcap. All information required by the protocol should be entered as it is obtained and an explanation should be provided for any missing data. Data analysis will be performed with the intention of addressing the study design. A drop-out rate of 30% is taken into account in the calculation of the sample size.
The sample size was estimated based on the ICQI-SF (intensity of UI symptoms) data from the study by Asklund et al (2018) because these are the only data available for an accurate calculation. The probability of error (alpha) was set at 0.10 and the power (1-beta) at 0.95. Based on these values, the sample size was calculated at 30 participants, or 15 per group. The standard deviation considered is 3.5 and the desired effect size is d=0.8 (strong).
Descriptive statistics will be carried out on the feasibility outcomes and on the outcomes of the final trial. Intention-to-treat analysis, inferential statistics will be considered in order to obtain primary results from the final trial. The objective is to investigate the relevance of the project by assessing differences between groups (inter-group analysis) and between evaluations (intra-group analysis). The thematic analysis of the qualitative data will be carried out in four phases as described by Braun & Clarke (2006) : (1) familiarization (2) identification of themes and units of meaning; (3) coding of transcripts; (4) concordance and reduction of redundancies. Phase 4 will allow for the comparison of categories and their refinement. The thematic analysis has the advantage of highlighting the analysis process through its transparency and the links between the stages of analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vaud
-
Lausanne, Vaud, Switzerland, 1011
- Bertuit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- women with SUI diagnosed by a doctor
Exclusion Criteria:
- Post-partum at least 1 year
- pregnant women
- mixt urinary incontinence
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Groupe 1 - Study group
The home program (outside of the sessions with the physiotherapist) will be done with a mobile application equipped with a vaginal probe. The exercises should be done 3x/week for 10 minutes (time corresponding to 1 programe). The correct use of the prob will have been checked during the sessions with the physiotherapist. This training will work on the strength, relaxation and endurance of the pelvic floor. The program includes 3 levels of difficulty. Once the user has successfully completed one level, she can move on to the next. |
Physiotherapy: Sessions with the physiotherapist will consist of information on anatomy, perineal awareness and behavioural therapy. The therapist will educate the patient on pelvic floor contraction/relaxation. the sessions will remain personalized and standardized like a classic treatment, and will also aim to work on motivation. 9 sessions during 3 months. Home Program: The home program will be done with a mobile application equipped with a vaginal probe. The exercises should be done 3x/week for 10 minutes. The correct use of the prob will have been checked during the sessions with the physiotherapist. This training will work on the strength, relaxation and endurance of the pelvic floor.The program includes 3 levels of difficulty. Once the user has successfully completed one level, she can move on to the next. |
Active Comparator: Groupe 2 - Control group
The home program (outside of the sessions with the physiotherapist) will be done without a mobile application. The exercises will have been explained during the sessions with the physiotherapist by oral instructions. The exercises will be done 3x/week for 10 minutes. The correct realization of the exercises will have been verified during the sessions with the physiotherapist. This training will work on pelvic floor strength, relaxation and endurance. The program includes 3 levels of difficulty |
Physiotherapy: Sessions with the physiotherapist will consist of information on anatomy, perineal awareness and behavioural therapy. The therapist will educate the patient on pelvic floor contraction/relaxation. The sessions will remain personalized and standardized like a classic treatment, and will also aim to work on motivation. 9 sessions during 3 months. Home program: The home program will be done without a mobile application. The exercises will have been explained during the sessions with the physiotherapist by oral instructions. The exercises will be done 3x/week for 10 minutes. The correct realization of the exercises will have been verified during the sessions with the physiotherapist. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of study with information from doctor, physiotherapist and patients
Time Frame: 6 months
|
Number of patients with the eligibility criteria over the recruitment period , Number of patients contacting physiotherapists to participate in the study over the recruitment period - Number of patients signing informed consent, enrolled over the duration of the study. Number of dropouts, timing. For each participant: her follow-up with dates. The patient's satisfaction with the PGI-I (Patient Global Impression Improvement). This questionnaire will be completed at the post-test observance of design: it will be evaluated via a "logbook" distributed to the patient . In relation to feasibility, we will evaluate the following parameters: The number of participants who complete the diary - The number of participants who follow the study guidelines - The number of participants who complete the home program, how often, for how long The number of participants who agree to participate in interviews |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence - Incontinence Treatment Motivation Questionnaire (ITMQ)
Time Frame: 3 months
|
via the Incontinence Treatment Motivation Questionnaire (ITMQ) pre- and post-tests performed during appointments with the partner physiotherapist.
The questionnaires will be completed by the project team with the participant.
|
3 months
|
Observance- logbook
Time Frame: 3 months
|
it will be evaluated via a "logbook" distributed to the patient to indicate the completion of the home program on a daily basis.
|
3 months
|
IU symptom - International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)- urinary calenda
Time Frame: 3 months
|
via the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and a urinary calendar.
The latter must be completed over 3 days at the beginning (pre-test) and end (post-test) of each participant's care.
|
3 months
|
Pelvic floor muscle functionality - PERFECT
Time Frame: 3 months
|
via PERFECT (P-power or pressure, E-endurance, R-repetition, F-fast contractions, ECT- every contraction timed) using digital vaginal palpation and the modified Oxford scale.
pre- and post-tests performed during appointments with the partner physiotherapist.
The questionnaires will be completed by the project team with the participant.
|
3 months
|
Quality of life - DITROVIE
Time Frame: 3 months
|
via DITROVIE.
pre- and post-tests performed during appointments with the partner physiotherapist.
The questionnaires will be completed by the project team with the participant.
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jeanne Bertuit, PhD, University of Applied Sciences of Western Switzerland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-01978
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urinary Incontinence
-
University of New MexicoRecruitingUrinary Incontinence | Urge Incontinence | Stress Incontinence, FemaleUnited States
-
Juna d.o.o.CompletedFemale Stress Urinary Incontinence | Mixed Incontinence, Urge and Stress
-
University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Stanford...CompletedUrinary Incontinence, Stress | Urge Incontinence | Urinary Stress Incontinence | Stress Incontinence, Urinary | Stress Incontinence | Stress Incontinence, Female | Urgency UrinaryUnited States
-
Ludwig-Maximilians - University of MunichUnknownIncontinence, Overactive Bladder, Stress Urinary IncontinenceGermany
-
San Diego Sexual MedicineRecruitingStress Urinary Incontinence | Urge IncontinenceUnited States
-
Copenhagen University Hospital at HerlevZealand University HospitalTerminatedStress Urinary Incontinence | Urge Urinary IncontinenceDenmark
-
ScitonCompletedUrinary Incontinence | Stress Urinary Incontinence | Urge IncontinenceUnited States
-
Far Eastern Memorial HospitalRecruitingWomen With Stress Urinary IncontinenceTaiwan
-
Université de SherbrookeRecruitingUrinary Incontinence | Urinary Stress Incontinence | Post-Prostatectomy Incontinence | Stress Incontinence, MaleCanada
-
University of ZurichCompletedStress Urinary Incontinence | Urge Urinary Incontinence
Clinical Trials on Perineal rehabilitation with mobile applications for women with SUI
-
Muhammed Onur HanedanCompleted
-
Cheng-Hsin General HospitalRecruitingBreast NeoplasmsTaiwan
-
Harvard Medical School (HMS and HSDM)Sangath; Beth Israel Deaconess Medical Center; National Institute of Mental Health... and other collaboratorsNot yet recruitingSchizophrenia | Schizophrenia and Related Disorders | Psychosocial Functioning
-
Peking Union Medical College HospitalRecruitingGestational Diabetes | Gestational Weight GainChina
-
VA Palo Alto Health Care SystemCompleted
-
University of California, San FranciscoUniversity of California, Los AngelesActive, not recruitingCOVID-19 | Pregnancy | CoronavirusUnited States
-
Columbia UniversityCompletedAttention Deficit Hyperactivity DisorderUnited States
-
Cukurova UniversityCompletedAnxiety | Activities of Daily Living | Patient Education | Postoperative Anxiety | Mobile EducationTurkey
-
Kaohsiung Veterans General Hospital.Recruiting
-
Istanbul University - Cerrahpasa (IUC)RecruitingPreeclampsia | Healthy Lifestyle | Pregnancy; Renal DiseaseTurkey