Urinary IncontinenceSUINCT04518683
Rehabilitation With Mobile Applications in Women With SUI
A study testing Perineal rehabilitation with mobile applications for women with SUI and Classic perineal rehabilitation for women with SUI in people with Urinary Incontinence and Stress Urinary Incontinence, run by University of Applied Sciences of Western Switzerland at 1 site in Switzerland.
Trial summary
Stress urinary incontinence (SUI) is the most common form of urinary incontinence in women. It affects women in their quality of life : physical, social, sexual and psychological levels. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Urinary Incontinence, Stress Urinary Incontinence
- What is being tested?
- Perineal rehabilitation with mobile applications for women with SUI and Classic perineal rehabilitation for women with SUI
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women with SUI diagnosed by a doctor
Who cannot join
- Post-partum at least 1 year
- pregnant women
- mixt urinary incontinence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a New Treatment Using Mobile Applications in the Treatment of Stress Urinary Incontinence in Women Outside the Peripartum - Pilot Study
Stress urinary incontinence (SUI) is the most common form of urinary incontinence in women. It affects women in their quality of life : physical, social, sexual and psychological levels. International recommendations suggest conservative treatments as first-line by training the pelvic floor muscles with or without a biofeedback-type control system. The latter allows the patient to visualize her muscle activity while stimulating her motivation. The part of adherence and compliance is very important in this rehabilitation where the woman must provide a significant commitment to continue the exercises beyond the support of the physiotherapist. In this area, a new approach is emerging with the arrival of health applications on smartphones. However, these tools lack scientific validation. The objective of this mixed pilot study (randomized controlled study with a qualitative part) is to investigate a new treatment for middle-aged to advanced patients outside the period of peripartum suffering from SUI, through an application mobile with probe as home program in standard physiotherapist treatment.
Read the 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.
- Conditions
- Urinary Incontinence, Stress Urinary Incontinence
- Being tested
- Perineal rehabilitation with mobile applications for women with SUI, Classic perineal rehabilitation for women with SUI
- Keywords
- stress urinary incontinence, mobile application, woman
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal rehabilitation with mobile applications for women with SUIDevice
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.
Classic perineal rehabilitation for women with SUIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Groupe 1 - Study group | Experimental | 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. Receives: Device: Perineal rehabilitation with mobile applications for women with SUI |
| Groupe 2 - Control group | Active comparator | 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 Receives: Device: Classic perineal rehabilitation for women with SUI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of study with information from doctor, physiotherapist and patients
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
Measured: 6 months
Secondary outcomes (5)
Adherence - Incontinence Treatment Motivation Questionnaire (ITMQ)
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.
Measured: 3 months
Observance- logbook
it will be evaluated via a "logbook" distributed to the patient to indicate the completion of the home program on a daily basis.
Measured: 3 months
IU symptom - International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)- urinary calenda
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.
Measured: 3 months
Pelvic floor muscle functionality - PERFECT
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.
Measured: 3 months
Quality of life - DITROVIE
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Oct 2020
- Primary completion1 Aug 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- study pilot mixte by a quantitative part corresponding to a randomized controlled intervention study and a phenomenological qualitative aspect
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences of Western Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Claire de Labrusse, Sandrine Balisson, Léa Dassonville
- Responsible party
- Principal investigator, Bertuit Jeanne, University of Applied Sciences of Western Switzerland
- Investigators
- Jeanne Bertuit, PhD, Principal investigator, University of Applied Sciences of Western Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518683
- Sponsor's protocol ID
- 2020-01978
- Acronym
- SUI
- Status last verified
- Jan 2023
- First submitted
- 12 Aug 2020
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Treatment Using Mobile Applications in the Treatment of Stress Urinary Incontinence in Women Outside the Peripartum - Pilot Study
- ClinicalTrials.gov ID
- NCT04518683
- Acronym / sponsor ID
- SUI / 2020-01978
- Conditions
- Urinary Incontinence, Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, mobile application, woman
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Applied Sciences of Western SwitzerlandUniversity, hospital or other
- Collaborators
- Claire de Labrusse, Sandrine Balisson, Léa Dassonville
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stress urinary incontinence (SUI) is the most common form of urinary incontinence in women. It affects women in their quality of life : physical, social, sexual and psychological levels. International recommendations suggest conservative treatments as first-line by training the pelvic floor muscles with or without a biofeedback-type control system. The latter allows the patient to visualize her muscle activity while stimulating her motivation. The part of adherence and compliance is very important in this rehabilitation where the woman must provide a significant commitment to continue the exercises beyond the support of the physiotherapist. In this area, a new approach is emerging with the arrival of health applications on smartphones. However, these tools lack scientific validation. The objective of this mixed pilot study (randomized controlled study with a qualitative part) is to investigate a new treatment for middle-aged to advanced patients outside the period of peripartum suffering from SUI, through an application mobile with probe as home program in standard physiotherapist treatment.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- study pilot mixte by a quantitative part corresponding to a randomized controlled intervention study and a phenomenological qualitative aspect
| Arm | Type | Receives |
|---|---|---|
| Groupe 1 - Study group | Experimental | Device: Perineal rehabilitation with mobile applications for women with SUIThe 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. |
| Groupe 2 - Control group | Active comparator | Device: Classic perineal rehabilitation for women with SUIThe 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 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women with SUI diagnosed by a doctor
Key exclusion criteria (3 listed)
- Post-partum at least 1 year
- pregnant women
- mixt urinary incontinence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineal rehabilitation with mobile applications for women with SUIPhysiotherapy: 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. | Device | Groupe 1 - Study group |
| Classic perineal rehabilitation for women with SUIPhysiotherapy: 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. | Device | Groupe 2 - Control group |
Primary outcome
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
5 secondary outcomes
Adherence - Incontinence Treatment Motivation Questionnaire (ITMQ)
Time frame: 3 months
Observance- logbook
Time frame: 3 months
IU symptom - International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)- urinary calenda
Time frame: 3 months
Pelvic floor muscle functionality - PERFECT
Time frame: 3 months
Quality of life - DITROVIE
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne Bertuit, PhD principal investigator
University of Applied Sciences of Western Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal rehabilitation with mobile applications for women with SUI and Classic perineal rehabilitation for women with SUI in people with Urinary Incontinence and Stress Urinary Incontinence, run by University of Applied Sciences of Western Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of study with information from doctor, physiotherapist and patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.