Urethral Length Measurement in Women Undergoing Suburethral Sling Operative Procedure

Completed

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT01660438
• Lead Sponsor: Cantonal Hospital, Frauenfeld

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-08
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 188

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cure rate	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Pad test	Pre-operation and 3 months
Urethral length measurement	Intra-operation	Urethral length will be measured using scaled catheters.
Pelvic floor sonography	Pre-operation, day 1 and 3 months
Residual urine	Pre-operation, day 1 and 3 months

Trial Locations

Locations (3)

Department of Gynecology and Obstetrics, Lutheran Hospital Hagen-Haspe; 🇩🇪 Hagen, Germany

Blasenzentrum, Cantonal Hospital; 🇨🇭 Frauenfeld, Thurgau, Switzerland

Szpital im M. Madurowicza; 🇵🇱 Lodz, Poland