Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence

Urinary Incontinence, Stress Clinical Trial

— IEUF  

Official title:

Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01563653
• Other study ID #: LOCAL/2011/RdeT-01
• Secondary ID: 2011-A01225-36
• Status: Terminated
• Phase: N/A
• First received: March 16, 2012
• Last updated: June 16, 2017
• Start date: February 20, 2014
• Est. completion date: February 23, 2017

Study information

• Verified date: June 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: February 23, 2017
• Est. primary completion date: February 23, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• 4 diagnostic tests for surgical success
Q-tip test, Bonney maneuver, TVT maneuver, clip strip test

Locations

Country	Name	City	State
France	CH de Dignes les Bains	Digne-les-Bains
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	58-60 weeks
Secondary	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	2-4 weeks
Secondary	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	6-8 weeks
Secondary	Positive Bonney maneuver	yes/no	2-4 weeks
Secondary	Positive Bonney maneuver	yes/no	6-8 weeks
Secondary	Positive TVT maneuver	yes/no	2-4 weeks
Secondary	Positive TVT maneuver	yes/no	6-8 weeks
Secondary	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	58-60 weeks
Secondary	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	58-60 weeks
Secondary	Intra-urethral pressure during the Bonney maneuver	mm Hg	2-4 weeks
Secondary	Intra-urethral pressure during the Bonney maneuver	mm Hg	6-8 weeks
Secondary	Intra-urethral pressure during the TVT maneuver	mm Hg	6-8 weeks
Secondary	Intra-urethral pressure during the TVT maneuver	mm Hg	2-4 weeks
Secondary	Intra-urethral pressure during the clip strip test	mm Hg	2-4 weeks
Secondary	Intra-urethral pressure during the clip strip test	mm Hg	6-8 weeks
Secondary	UDI-6 questionnaire		2-4 weeks
Secondary	UDI-6 questionnaire		12-14 weeks
Secondary	UDI-6 questionnaire		58-60 weeks
Secondary	IIQ7 questionnaire		2-4 weeks
Secondary	IIQ7 questionnaire		12-14 weeks
Secondary	IIQ7 questionnaire		58-60 weeks
Secondary	PGI-I Questionnaire		58-60 weeks
Secondary	Intra- and inter operator reproducability for 4 diagnostic tests	Bonney maneuver, q-tip test, tvt maneuver and clip strip test	2-4 weeks
Secondary	Intra- and inter operator reproducability for 4 diagnostic tests	Bonney maneuver, q-tip test, tvt maneuver and clip strip test	6-8 weeks
Secondary	Angle associated with Q-tip test		2-4 weeks
Secondary	Angle associated with Q-tip test		6-8 weeks