Urinary IncontinenceNCT03254355
Efficacy of Physiotherapy for Urinary Incontinence in Women With a Puborectalis Avulsion
A study testing Multimodal physiotherapy in people with Urinary Incontinence and Postpartum, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Childbirth is a major risk factor for pelvic floor muscle (PFM) trauma. In one third of women, stretching of the PFM will result in an avulsion injury (i.e. disconnection of the muscle from its insertion points on the pubic symphysis). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Urinary Incontinence, Postpartum, Pelvic Floor; Perineal Rupture, Obstetric
- What is being tested?
- Multimodal physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteCanada
- Study dates
- 28 Aug 2017to 10 May 2023
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-45 years old
- Postpartum women (≥ 1 vaginal delivery at term (≥ 37 weeks) and ≥ 3 months postpartum
- ≥ 3 urinary incontinence episodes per week over the last 3 months (Symptoms of incontinence must be associated predominantly or solely with stress urinary incontinence (as opposed to urge incontinence) which will be determined with a recommended and validated diagnosis questionnaire (Questionnaire for Urinary Incontinence Diagnosis))
- Women with diagnosis avulsion injury
Who cannot join
- Pregnancy or postmenopausal
- Previous pelvic irradiation, urogynecological surgery, or PFM physiotherapy after the avulsion occurred
- Significant prolapse (≥3 degree)
- Incontinence due to other causes such as infection, neurological diseases, voiding difficulties
- Any other acute or chronic medical problems likely to interfere with treatment or evaluation such as cancer, chronic constipation (Rome III criteria), obesity (body mass index >35), pacemaker, bladder stimulator
- Medication or ongoing treatment likely to interfere with incontinence
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Efficacy of Physiotherapy for Urinary Incontinence in Women With a Known Avulsion Injury of the Puborectalis Muscle: A Randomized Controlled Trial
Childbirth is a major risk factor for pelvic floor muscle (PFM) trauma. In one third of women, stretching of the PFM will result in an avulsion injury (i.e. disconnection of the muscle from its insertion points on the pubic symphysis). Recent advances in imaging have led to the discovery of this previously unknown major injury and further research now enables its diagnosis with readily available techniques. Avulsion injury has alarming consequences because it has been associated with a higher rate of urinary incontinence in the postpartum period as well as the long-term development of other major urogynecological conditions such as pelvic organ prolapse and anal incontinence. Women with avulsion not only suffer from severe symptoms with significant related impacts on physical activities, overall well-being and quality of life, but they also present a higher rate of surgical failures. Moreover, it is still unknown whether the most recommended first-line treatment for urinary incontinence -PFM physiotherapy- is effective in women with this major trauma. Until now, only a pilot study conducted by our team supports the rationale and the efficacy of physiotherapy for improving PFM function in women with avulsion, despite their major muscle injury.
Primary objective: To evaluate the efficacy of physiotherapy for urinary incontinence in women with avulsion at 9-months after randomization compared to a waiting-list control group.
Read more
Secondary objectives:
- To compare physiotherapy to the control group after treatment and at 9-months after randomization in terms of: a) incontinence and prolapse (objective quantification, symptoms and related impact); b) PFM morphology and function; c) sexual function; d) self-efficacy; e) cost analysis; f) treatment satisfaction and impression of change.
- To investigate the impact of the severity of the avulsion (i.e. unilateral or bilateral) on the response to physiotherapy treatment on the aforementioned outcomes.
Read the detailed description
This is a multicenter randomized controlled trial using a parallel group design that involves women with a confirmed diagnosis of avulsion and suffering from urinary incontinence. Participants will be randomized into either physiotherapy or a waiting-list control group. Both groups will be evaluated at baseline, post-treatment (3 months post-randomization) and 9 months after randomization. Women in the control group will receive full-body relaxation massage which has shown no effect on continence but was selected to control for effects of attention received by the therapist. After the 9-month assessment, women assigned to the control group will receive the same physiotherapy treatment and undergo a last assessment.
- Conditions
- Urinary Incontinence, Postpartum, Pelvic Floor; Perineal Rupture, Obstetric, Physiotherapy
- Being tested
- Multimodal physiotherapy
- Keywords
- avulsion injury, urinary incontinence, multimodal physiotherapy
- Medical subject headings
- Urinary Incontinence, Fractures, Avulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal physiotherapyProcedure or surgery
12 weeks of weekly physiotherapy treatments including education segment, electrical stimulation and PFM exercises consisting of strength, endurance and coordination exercises accompanied by biofeedback
| Study group | Role | What they receive |
|---|---|---|
| Multimodal physiotherapy | Experimental | 12 weeks of weekly multimodal physiotherapy treatments Receives: Procedure: Multimodal physiotherapy |
| Waiting-list control group | No intervention | 12 weeks of weekly full-body relaxation massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in the number of urinary incontinence episodes
The 7-day bladder diary was selected as the primary outcome to measure urinary leakage reduction
Measured: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Secondary outcomes (7)
Change in symptoms and impact of incontinence and other urogynecological conditions
Evaluated with ICI Modular Questionnaires (ICIQ), Pelvic Floor Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ-SF) and Pelvic Organ Prolapse Symptom score (POP-SS)
Measured: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Change in pelvic floor muscle morphometry and function
Evaluated with transperineal ultrasound and dynamometry
Measured: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Change in severity of prolapse
Evaluated with POP-Q assessment
Measured: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Change in sexual function
Evaluated with Female Sexual Function Index (FSFI) and Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-SF)
Measured: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Change in self-efficacy
Evaluated with Broom Pelvic Muscle Self-Efficacy Scale
Measured: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Cost analysis
Evaluated with Dowell-Bryant Incontinence Cost Index (DBICI)
Measured: baseline and 9 months after randomization
Treatment satisfaction and impression of change
Evaluated with Patient Satisfaction Questionnaire (PSQ) and Patient's Global Impression of Change (PGIC)
Measured: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start28 Aug 2017
- Primary completion10 May 2023
- Study completion10 May 2023
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.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Mélanie Morin, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254355
- Sponsor's protocol ID
- MP-31-2018-1758
- Status last verified
- Jun 2023
- First submitted
- 9 Aug 2017
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Physiotherapy for Urinary Incontinence in Women With a Known Avulsion Injury of the Puborectalis Muscle: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03254355
- Acronym / sponsor ID
- MP-31-2018-1758
- Conditions
- Urinary Incontinence, Postpartum, Pelvic Floor; Perineal Rupture, Obstetric, Physiotherapy
- Keywords
- avulsion injury, urinary incontinence, multimodal physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 18 Aug 2017 (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.
Childbirth is a major risk factor for pelvic floor muscle (PFM) trauma. In one third of women, stretching of the PFM will result in an avulsion injury (i.e. disconnection of the muscle from its insertion points on the pubic symphysis). Recent advances in imaging have led to the discovery of this previously unknown major injury and further research now enables its diagnosis with readily available techniques. Avulsion injury has alarming consequences because it has been associated with a higher rate of urinary incontinence in the postpartum period as well as the long-term development of other major urogynecological conditions such as pelvic organ prolapse and anal incontinence. Women with avulsion not only suffer from severe symptoms with significant related impacts on physical activities, overall well-being and quality of life, but they also present a higher rate of surgical failures. Moreover, it is still unknown whether the most recommended first-line treatment for urinary incontinence -PFM physiotherapy- is effective in women with this major trauma. Until now, only a pilot study conducted by our team supports the rationale and the efficacy of physiotherapy for improving PFM function in women with avulsion, despite their major muscle injury.
Primary objective: To evaluate the efficacy of physiotherapy for urinary incontinence in women with avulsion at 9-months after randomization compared to a waiting-list control group.
Secondary objectives:
- To compare physiotherapy to the control group after treatment and at 9-months after randomization in terms of: a) incontinence and prolapse (objective quantification, symptoms and related impact); b) PFM morphology and function; c) sexual function; d) self-efficacy; e) cost analysis; f) treatment satisfaction and impression of change.
- To investigate the impact of the severity of the avulsion (i.e. unilateral or bilateral) on the response to physiotherapy treatment on the aforementioned outcomes.
Detailed description
This is a multicenter randomized controlled trial using a parallel group design that involves women with a confirmed diagnosis of avulsion and suffering from urinary incontinence. Participants will be randomized into either physiotherapy or a waiting-list control group. Both groups will be evaluated at baseline, post-treatment (3 months post-randomization) and 9 months after randomization. Women in the control group will receive full-body relaxation massage which has shown no effect on continence but was selected to control for effects of attention received by the therapist. After the 9-month assessment, women assigned to the control group will receive the same physiotherapy treatment and undergo a last assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal physiotherapy | Experimental | Procedure: Multimodal physiotherapy12 weeks of weekly multimodal physiotherapy treatments |
| Waiting-list control group | No intervention | –12 weeks of weekly full-body relaxation massage |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-45 years old
- Postpartum women (≥ 1 vaginal delivery at term (≥ 37 weeks) and ≥ 3 months postpartum
- ≥ 3 urinary incontinence episodes per week over the last 3 months (Symptoms of incontinence must be associated predominantly or solely with stress urinary incontinence (as opposed to urge incontinence) which will be determined with a recommended and validated diagnosis questionnaire (Questionnaire for Urinary Incontinence Diagnosis))
- Women with diagnosis avulsion injury
Key exclusion criteria (6 listed)
- Pregnancy or postmenopausal
- Previous pelvic irradiation, urogynecological surgery, or PFM physiotherapy after the avulsion occurred
- Significant prolapse (≥3 degree)
- Incontinence due to other causes such as infection, neurological diseases, voiding difficulties
- Any other acute or chronic medical problems likely to interfere with treatment or evaluation such as cancer, chronic constipation (Rome III criteria), obesity (body mass index >35), pacemaker, bladder stimulator
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 |
|---|---|---|
| Multimodal physiotherapy12 weeks of weekly physiotherapy treatments including education segment, electrical stimulation and PFM exercises consisting of strength, endurance and coordination exercises accompanied by biofeedback | Procedure or surgery | Multimodal physiotherapy |
Primary outcome
Percent reduction in the number of urinary incontinence episodes
Time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
The 7-day bladder diary was selected as the primary outcome to measure urinary leakage reduction
7 secondary outcomes
Change in symptoms and impact of incontinence and other urogynecological conditions
Time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Change in pelvic floor muscle morphometry and function
Time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Change in severity of prolapse
Time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Change in sexual function
Time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Change in self-efficacy
Time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
Cost analysis
Time frame: baseline and 9 months after randomization
Treatment satisfaction and impression of change
Time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
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 15 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal physiotherapy in people with Urinary Incontinence and Postpartum, run by Université de Sherbrooke at 1 site in Canada.
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 4 inclusion and 6 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 15 Jun 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 Canada. 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?
Percent reduction in the number of urinary incontinence episodes (time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization). 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 15 Jun 2023.