Urethral Length Measurement in Women Undergoing Suburethral Sling Operative Procedure

Stress Urinary Incontinence Clinical Trial

Official title:

Prospective, Non-randomized, Observational Study of the Surgical Management of Suburethral Slings in Women With Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660438
• Other study ID #: TVT 112010
• Status: Completed
• Phase: N/A
• First received: August 6, 2012
• Last updated: May 19, 2016
• Start date: August 2010
• Est. completion date: February 2013

Study information

• Verified date: May 2016
• Source: Cantonal Hospital, Frauenfeld
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial Summary

This is a prospective, non-randomized, observational, multicenter study in which urethral length is measured in women with surgically-correctable stress urinary incontinence who undergo a suburethral sling operative procedure.

Description:

This is a prospective, non-randomized, observational, multicenter study in which urethral length is measured in women with surgically-correctable stress urinary incontinence who undergo a suburethral sling operative procedure. Data will be collected from preoperative urogynecological testing and medical histories. The urethral length will be measured intraoperatively using scaled catheters. Outcome data, including the development of postoperative complications, will be collected at several time intervals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient has objective, demonstrable signs of stress urinary incontinence (SUI), including patients with intrinsic sphincter deficiency (ISD). Objective testing includes: standing stress test, urodynamics evaluation or pad test.

2. Patient is age 18 or older.

3. Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the Institutional Review Board/Ethics Committee-approved informed consent form.

4. Patient is able to fill in all questionnaires (based on judgment of investigator)

Exclusion Criteria:

1. Patient has an associated or suspected neurological disease.

2. Patient has an active lesion or present injury to perineum or urethra.

3. Patient has a urethral obstruction.

4. Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.

5. Patient has current urinary tract infection.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Locations

Country	Name	City	State
Germany	Department of Gynecology and Obstetrics, Lutheran Hospital Hagen-Haspe	Hagen
Poland	Szpital im M. Madurowicza	Lodz
Switzerland	Blasenzentrum, Cantonal Hospital	Frauenfeld	Thurgau

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital, Frauenfeld

Countries where clinical trial is conducted

Germany,  Poland,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate	Patients are classified as 'cured' if the postoperative cough test is negative, the 1-hour pad test is negative (less than 2 g) and the degree of subjective suffering improves to over 90% (VAS score of 0 or 1). All other patients are classified as therapeutic 'failures', even though they may experience marked improvement in one of the parameters compared with their preoperative status.	3 months	No
Secondary	Pelvic floor sonography		Pre-operation, day 1 and 3 months	No
Secondary	Residual urine		Pre-operation, day 1 and 3 months	No
Secondary	Pad test		Pre-operation and 3 months	No
Secondary	Urethral length measurement	Urethral length will be measured using scaled catheters.	Intra-operation	No