Postpartum Urinary IncontinenceNCT06031870
Pelvic Floor Rehabilitation Study (Beckenboden-Rehabilitationsstudie - BREST)
A study testing Vaginal pessary and Pelvic floor muscle training in people with Postpartum Urinary Incontinence, run by Medical University of Vienna at 4 sites in Germany.
Trial summary
This study compares the effectiveness of standard care, pelvic floor muscle training or vaginal pessary for the treatment of postpartum urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Urinary Incontinence
- What is being tested?
- Vaginal pessary and Pelvic floor muscle training
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 4 sitesGermany
- Study dates
- 1 Sep 2018to 31 Aug 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- gave birth within the 12 weeks prior to the postpartum visit
- postpartum urinary incontinence
- able to understand and give consent in German
Who cannot join
- treatment for postpartum urinary incontinence that started prior to inclusion
- any neurologic disease that impairs bladder function
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Die GynPraxis
Alzey
Die GynPraxis
Bad Kreuznach
Die GynPraxis
Lampertheim
Die GynPraxis
Mainz
About this study
Official title: Beckenboden-Rehabilitationsstudie (BREST)
This study compares the effectiveness of standard care, pelvic floor muscle training or vaginal pessary for the treatment of postpartum urinary incontinence.
- Conditions
- Postpartum Urinary Incontinence
- Being tested
- Vaginal pessary, Standard care, Pelvic floor muscle training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal pessaryDevice
In the pessary group, all patients received a cube pessary, which was individually adapted to each patient. These pessaries exist in sizes 0 (25 mm edge length) to 9 (75 mm edge length). Patients were instructed by a physician or a trained nurse on how to autonomously manage the pessary, including daily changing and cleaning. After one week of treatment, all patients had an office visit to check if fitting was correct and if autonomous handling of the pessary was feasible. Treatment duration was 12 weeks.
Standard careBehavioural
Standard care consisted of a pelvic floor group exercise course led by a midwife, a physiotherapist, or an osteopath. Courses were in general once a week for a minimum of seven to a maximum of twelve weeks. The course was chosen by the patient, and the study team had no influence on the choice.
Pelvic floor muscle trainingProcedure or surgery
Twelve pelvic floor physiotherapy sessions were prescribed by the study physician. Pelvic floor physiotherapy was performed in individual courses by trained physiotherapists. The patient was free to choose the physiotherapist and the study team had no influence on the choice.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Not described Receives: Behavioral: Standard care |
| Pelvic floor muscle training | Active comparator | Not described Receives: Procedure: Pelvic floor muscle training |
| Vaginal pessary | Experimental | Not described Receives: Device: Vaginal pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients' self-reported satisfaction with the treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Sep 2018
- Primary completion30 Apr 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soren Lange, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031870
- Sponsor's protocol ID
- 2018-13832
- Other IDs
- 2018
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beckenboden-Rehabilitationsstudie (BREST)
- ClinicalTrials.gov ID
- NCT06031870
- Acronym / sponsor ID
- 2018-13832
- Conditions
- Postpartum Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 11 Sep 2023 (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.
This study compares the effectiveness of standard care, pelvic floor muscle training or vaginal pessary for the treatment of postpartum urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Behavioral: Standard care |
| Pelvic floor muscle training | Active comparator | Procedure: Pelvic floor muscle training |
| Vaginal pessary | Experimental | Device: Vaginal pessary |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- gave birth within the 12 weeks prior to the postpartum visit
- postpartum urinary incontinence
- able to understand and give consent in German
Key exclusion criteria (2 listed)
- treatment for postpartum urinary incontinence that started prior to inclusion
- any neurologic disease that impairs bladder function
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 |
|---|---|---|
| Vaginal pessaryIn the pessary group, all patients received a cube pessary, which was individually adapted to each patient. These pessaries exist in sizes 0 (25 mm edge length) to 9 (75 mm edge length). Patients were instructed by a physician or a trained nurse on how to autonomously manage the pessary, including daily changing and cleaning. After one week of treatment, all patients had an office visit to check if fitting was correct and if autonomous handling of the pessary was feasible. Treatment duration was 12 weeks. | Device | Vaginal pessary |
| Standard careStandard care consisted of a pelvic floor group exercise course led by a midwife, a physiotherapist, or an osteopath. Courses were in general once a week for a minimum of seven to a maximum of twelve weeks. The course was chosen by the patient, and the study team had no influence on the choice. | Behavioural | Standard care |
| Pelvic floor muscle trainingTwelve pelvic floor physiotherapy sessions were prescribed by the study physician. Pelvic floor physiotherapy was performed in individual courses by trained physiotherapists. The patient was free to choose the physiotherapist and the study team had no influence on the choice. | Procedure or surgery | Pelvic floor muscle training |
Primary outcome
patients' self-reported satisfaction with the treatment
Time frame: 12 weeks
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 11 Sep 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Postpartum Urinary Incontinence
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Comparative Effects of Hypopressive and Transverses Abdominis Focused Core Training in Postpartum
Postpartum
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MoVo-guided Traditional Chinese Kegel Exercises for Preventing Postpartum Urinary Incontinence.
Stress Urinary Incontinence
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Comparative Effects of Hypopressive Exercises and Paula Method in Postpartum Women.
Urinary Incontinence (UI)
Recruiting
The RECOVER Study - Postpartum Recovery of Pelvic Floor Structures and the Impact of Early Rehabilitation
Urinary Incontinence, Pelvic Organ Prolapse (POP)
Recruiting
The Impact of Breathing Training on PPSUI: A Randomized Controlled Trial
Stress Urinary Incontinence (SUI)
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal pessary and Pelvic floor muscle training in people with Postpartum Urinary Incontinence, run by Medical University of Vienna at 4 sites in Germany.
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 2 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 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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?
patients' self-reported satisfaction with the treatment (time frame: 12 weeks). 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 11 Sep 2023.