Stress Urinary IncontinenceNCT04114019
The Effect of Pelvic Floor Physiotherapy on Vaginal Elasticity
An observational study of Stress Urinary Incontinence, run by Rambam Health Care Campus.
Trial summary
Women suffering from stress urinary incontinence are offered pelvic floor physiotherapy as an optional treatment. Strengthening of the pelvic floor is measured to date by manual examination and lacks precise evaluation. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Vaginal tactile imager
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 1 Apr 2021
- Phase
- Observational
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women between 18-70 years of age, suffering from stress urinary incontinence, referred to pelvic floor physiotherapy.
Who may be able to join
- women suffering from stress urinary incontinence.
Who cannot join
- women suffering from urge urinary incontinence.
- women suffering of mixed urinary incontinence.
About this study
Official title: The Effect of Pelvic Floor Physiotherapy on Vaginal Elasticity as Measured by a Vaginal Tactile Imager
Women suffering from stress urinary incontinence are offered pelvic floor physiotherapy as an optional treatment. Strengthening of the pelvic floor is measured to date by manual examination and lacks precise evaluation. The vaginal tactile imager assists in evaluation of the changes in the pelvic floor after physiotherapy.
Read the detailed description
Women with stress urinary incontinence will undergo 6-10 pelvic floor strengthening physiotherapy sessions. The participants will undergo a short examination of vaginal elasticity using a vaginal tactile imager prior to beginning physiotherapy and additional examinations after 6 treatments, 10 treatments and 3 and 6 months post-treatment cessation.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Vaginal tactile imager
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal tactile imagerDiagnostic test
Vaginal elasticity evaluation using a vaginal tactile imager
| Study group | Role | What they receive |
|---|---|---|
| Stress urinary incontinence | Women suffering from stress urinary incontinence Receives: Diagnostic Test: Vaginal tactile imager |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Elasticity
Changes in vaginal elasticity post physiotherapy
Measured: From the treatment cessation up to 6 months post-treatment
Secondary outcomes (1)
Stress urinary incontinence
Improvement in the urogenital distress inventory questionnaire score (range 0-15)
Measured: From the treatment cessation up to 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Jul 2020 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion1 Apr 2021 (estimated)
Why it stopped: The study device became unavailable for use.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Roy Lauterbach, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114019
- Sponsor's protocol ID
- 0327-19-RMB
- Status last verified
- Jul 2020
- First submitted
- 1 Oct 2019
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pelvic Floor Physiotherapy on Vaginal Elasticity as Measured by a Vaginal Tactile Imager
- ClinicalTrials.gov ID
- NCT04114019
- Acronym / sponsor ID
- 0327-19-RMB
- Conditions
- Stress Urinary Incontinence
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study device became unavailable for use.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 3 Oct 2019 (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.
Women suffering from stress urinary incontinence are offered pelvic floor physiotherapy as an optional treatment. Strengthening of the pelvic floor is measured to date by manual examination and lacks precise evaluation. The vaginal tactile imager assists in evaluation of the changes in the pelvic floor after physiotherapy.
Detailed description
Women with stress urinary incontinence will undergo 6-10 pelvic floor strengthening physiotherapy sessions. The participants will undergo a short examination of vaginal elasticity using a vaginal tactile imager prior to beginning physiotherapy and additional examinations after 6 treatments, 10 treatments and 3 and 6 months post-treatment cessation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress urinary incontinence | – | Diagnostic Test: Vaginal tactile imagerWomen suffering from stress urinary incontinence |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women between 18-70 years of age, suffering from stress urinary incontinence, referred to pelvic floor physiotherapy.
Key inclusion criteria (1 listed)
- women suffering from stress urinary incontinence.
Key exclusion criteria (2 listed)
- women suffering from urge urinary incontinence.
- women suffering of mixed 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 |
|---|---|---|
| Vaginal tactile imagerVaginal elasticity evaluation using a vaginal tactile imager | Diagnostic test | Stress urinary incontinence |
Primary outcome
Vaginal Elasticity
Time frame: From the treatment cessation up to 6 months post-treatment
Changes in vaginal elasticity post physiotherapy
1 secondary outcome
Stress urinary incontinence
Time frame: From the treatment cessation up to 6 months post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Roy Lauterbach, MD principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, run by Rambam Health Care Campus.
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 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: withdrawn, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Vaginal Elasticity (time frame: From the treatment cessation up to 6 months post-treatment). 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 27 Jul 2020.