Urinary Incontinence, StressIEUFNCT01563653
Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence
A study testing 4 diagnostic tests for surgical success in people with Urinary Incontinence, Stress, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
The investigators hypothesize that an innovative test device simulating transvaginal tape support will increase the performance and reproducibility of the diagnosis of urethral hypermobility before surgery for urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- 4 diagnostic tests for surgical success
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Feb 2014to 23 Feb 2017
- 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
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 60 weeks of follow-up
- Candidate for stress urinary incontinence surgery by TVT or TOT procedures
- Positive cough or valsalve maneuver test
Who cannot join
- The patient is participating in another study (except the PISQ-R study)
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient, or breastfeeding
Show all 9Show fewer
- The patient has a contra-indication for stress urinary incontinence surgery via TVT or TOT procedures.
- The patient has an untreated vaginal or urniary infection
- The patient has a history of allergy to polyurethane and / or Watershed XCX11122
Trial locations and contacts
2 sites in 1 country.
France2 sites
CH de Dignes les Bains
Digne-les-Bains, 04000
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, Gard, 30029
About this study
The investigators hypothesize that an innovative test device simulating transvaginal tape support will increase the performance and reproducibility of the diagnosis of urethral hypermobility before surgery for urinary incontinence.
The main objective of this study is to compare two prognostic tests in their ability to predict the success (or failure) of the implementation of a suburethral TVT (tension-free vaginal tape) or TOT (trans-obturator tape) treatment for stress urinary incontinence in women. The Q-tip test (test mentioned in the French and international recommendations) is compared to test a new test (clip strip).
Read the detailed description
Secondary objectives include:
- Compare the prognostic ability of the clip strip test with the Bonney maneuver
- Compare the prognostic ability of the clip strip test with the TVT maneuver
- Compare the maximum intraurethral pressure during various tests
- Compare the quality of life before / after surgery
- Estimate patient satisfaction one year after surgery
- Describe the intra and inter-operator reproducibility of various prognostic tests.
- Estimate the optimal threshold of the Q-tip angle based on surgical results and compare with the reference threshold of 30 ° found in the literature.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- 4 diagnostic tests for surgical success
- Keywords
- predicting surgical success, simple diagnostic test device
- 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.
4 diagnostic tests for surgical successProcedure or surgery
Q-tip test, Bonney maneuver, TVT maneuver, clip strip test
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Women with stress urinary incontinence schelduled for TVT or TOT procedures. See inclusion/exclusion criteria. Receives: Procedure: 4 diagnostic tests for surgical success |
What is being measured
The primary outcome is the main question the study is designed to answer.
McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results
McNemar test for comparing sensitivity and specificity between two factors
Measured: 58-60 weeks
Secondary outcomes (25)
McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results
McNemar test for comparing sensitivity and specificity between two factors
Measured: 2-4 weeks
McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results
McNemar test for comparing sensitivity and specificity between two factors
Measured: 6-8 weeks
Positive Bonney maneuver
yes/no
Measured: 2-4 weeks
Positive Bonney maneuver
yes/no
Measured: 6-8 weeks
Positive TVT maneuver
yes/no
Measured: 2-4 weeks
Positive TVT maneuver
yes/no
Measured: 6-8 weeks
McNemar Score: Clip strip test versus Bonney maneuvre
Comparison of the prognostic capacities of the clip strip and Bonney maneuver tests. McNemar test for comparing sensitivity and specificity between two factors
Measured: 58-60 weeks
McNemar Score: Clip strip test TVT Bonney maneuvre
Comparison of the prognostic capacities of the clip strip and TVT maneuver tests. McNemar test for comparing sensitivity and specificity between two factors
Measured: 58-60 weeks
Intra-urethral pressure during the Bonney maneuver
mm Hg
Measured: 2-4 weeks
Intra-urethral pressure during the Bonney maneuver
mm Hg
Measured: 6-8 weeks
Intra-urethral pressure during the TVT maneuver
mm Hg
Measured: 6-8 weeks
Intra-urethral pressure during the TVT maneuver
mm Hg
Measured: 2-4 weeks
Intra-urethral pressure during the clip strip test
mm Hg
Measured: 2-4 weeks
Intra-urethral pressure during the clip strip test
mm Hg
Measured: 6-8 weeks
UDI-6 questionnaire
Measured: 2-4 weeks
UDI-6 questionnaire
Measured: 12-14 weeks
UDI-6 questionnaire
Measured: 58-60 weeks
IIQ7 questionnaire
Measured: 2-4 weeks
IIQ7 questionnaire
Measured: 12-14 weeks
IIQ7 questionnaire
Measured: 58-60 weeks
PGI-I Questionnaire
Measured: 58-60 weeks
Intra- and inter operator reproducability for 4 diagnostic tests
Bonney maneuver, q-tip test, tvt maneuver and clip strip test
Measured: 2-4 weeks
Intra- and inter operator reproducability for 4 diagnostic tests
Bonney maneuver, q-tip test, tvt maneuver and clip strip test
Measured: 6-8 weeks
Angle associated with Q-tip test
Measured: 2-4 weeks
Angle associated with Q-tip test
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study start20 Feb 2014
- Primary completion23 Feb 2017
- Study completion23 Feb 2017
Why it stopped: Not enough inclusions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renaud de Tayrac, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563653
- Sponsor's protocol ID
- LOCAL/2011/RdeT-01
- Other IDs
- 2011-A01225-36
- Acronym
- IEUF
- Status last verified
- Jun 2017
- First submitted
- 16 Mar 2012
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence
- ClinicalTrials.gov ID
- NCT01563653
- Acronym / sponsor ID
- IEUF / LOCAL/2011/RdeT-01
- Conditions
- Urinary Incontinence, Stress
- Keywords
- predicting surgical success, simple diagnostic test device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough inclusions.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 20 Feb 2014 (actual)
- Primary completion
- 23 Feb 2017 (actual)
- Study completion
- 23 Feb 2017 (actual)
- First posted
- 27 Mar 2012 (estimated)
- 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.
The investigators hypothesize that an innovative test device simulating transvaginal tape support will increase the performance and reproducibility of the diagnosis of urethral hypermobility before surgery for urinary incontinence.
The main objective of this study is to compare two prognostic tests in their ability to predict the success (or failure) of the implementation of a suburethral TVT (tension-free vaginal tape) or TOT (trans-obturator tape) treatment for stress urinary incontinence in women. The Q-tip test (test mentioned in the French and international recommendations) is compared to test a new test (clip strip).
Detailed description
Secondary objectives include:
- Compare the prognostic ability of the clip strip test with the Bonney maneuver
- Compare the prognostic ability of the clip strip test with the TVT maneuver
- Compare the maximum intraurethral pressure during various tests
- Compare the quality of life before / after surgery
- Estimate patient satisfaction one year after surgery
- Describe the intra and inter-operator reproducibility of various prognostic tests.
- Estimate the optimal threshold of the Q-tip angle based on surgical results and compare with the reference threshold of 30 ° found in the literature.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: 4 diagnostic tests for surgical successWomen with stress urinary incontinence schelduled for TVT or TOT procedures. See inclusion/exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 60 weeks of follow-up
- Candidate for stress urinary incontinence surgery by TVT or TOT procedures
- Positive cough or valsalve maneuver test
Key exclusion criteria (9 listed)
- The patient is participating in another study (except the PISQ-R study)
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
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 |
|---|---|---|
| 4 diagnostic tests for surgical successQ-tip test, Bonney maneuver, TVT maneuver, clip strip test | Procedure or surgery | Patients |
Primary outcome
McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results
Time frame: 58-60 weeks
McNemar test for comparing sensitivity and specificity between two factors
25 secondary outcomes
McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results
Time frame: 2-4 weeks
McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results
Time frame: 6-8 weeks
Positive Bonney maneuver
Time frame: 2-4 weeks
Positive Bonney maneuver
Time frame: 6-8 weeks
Positive TVT maneuver
Time frame: 2-4 weeks
Positive TVT maneuver
Time frame: 6-8 weeks
McNemar Score: Clip strip test versus Bonney maneuvre
Time frame: 58-60 weeks
McNemar Score: Clip strip test TVT Bonney maneuvre
Time frame: 58-60 weeks
Intra-urethral pressure during the Bonney maneuver
Time frame: 2-4 weeks
Intra-urethral pressure during the Bonney maneuver
Time frame: 6-8 weeks
Intra-urethral pressure during the TVT maneuver
Time frame: 6-8 weeks
Intra-urethral pressure during the TVT maneuver
Time frame: 2-4 weeks
Intra-urethral pressure during the clip strip test
Time frame: 2-4 weeks
Intra-urethral pressure during the clip strip test
Time frame: 6-8 weeks
UDI-6 questionnaire
Time frame: 2-4 weeks
UDI-6 questionnaire
Time frame: 12-14 weeks
UDI-6 questionnaire
Time frame: 58-60 weeks
IIQ7 questionnaire
Time frame: 2-4 weeks
IIQ7 questionnaire
Time frame: 12-14 weeks
IIQ7 questionnaire
Time frame: 58-60 weeks
PGI-I Questionnaire
Time frame: 58-60 weeks
Intra- and inter operator reproducability for 4 diagnostic tests
Time frame: 2-4 weeks
Intra- and inter operator reproducability for 4 diagnostic tests
Time frame: 6-8 weeks
Angle associated with Q-tip test
Time frame: 2-4 weeks
Angle associated with Q-tip test
Time frame: 6-8 weeks
Results and safety
The study was stopped early (reason given: Not enough inclusions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
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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.
Renaud de Tayrac, MD PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 diagnostic tests for surgical success in people with Urinary Incontinence, Stress, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 was stopped early (reason given: Not enough inclusions.). Results are not available in the source record.
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?
McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results (time frame: 58-60 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 19 Jun 2017.