Urethral Length Measurement in Women Undergoing Suburethral Sling Operative Procedure
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.
Stress Urinary Incontinence
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective, Non-randomized, Observational Study of the Surgical Management of Suburethral Slings in Women With Stress Urinary Incontinence|
- Cure rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
- Pelvic floor sonography [ Time Frame: Pre-operation, day 1 and 3 months ] [ Designated as safety issue: No ]
- Residual urine [ Time Frame: Pre-operation, day 1 and 3 months ] [ Designated as safety issue: No ]
- Pad test [ Time Frame: Pre-operation and 3 months ] [ Designated as safety issue: No ]
- Urethral length measurement [ Time Frame: Intra-operation ] [ Designated as safety issue: No ]Urethral length will be measured using scaled catheters.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Stress urinary incontinence
Stress urinary incontinence
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.
|Contact: Volker Viereck, Prof. Dr.||++41 52 723 70 email@example.com|
|Contact: Oliver Rautenberg, Dr. med.||++41 52 723 77 firstname.lastname@example.org|
|Department of Gynecology and Obstetrics, Lutheran Hospital Hagen-Haspe||Recruiting|
|Contact: Jacek Kociszewski, Dr. med. email@example.com|
|Principal Investigator: Jacek Kociszewski, Dr. med.|
|Szpital im M. Madurowicza||Recruiting|
|Contact: Grzegorz Surkont, dr n. med. firstname.lastname@example.org|
|Principal Investigator: Grzegorz Surkont, dr n. med.|
|Blasenzentrum, Cantonal Hospital||Recruiting|
|Frauenfeld, Thurgau, Switzerland|
|Contact: Volker Viereck, Prof. Dr. ++41 52 723 70 50 email@example.com|
|Contact: Oliver Rautenberg, Dr. med. ++41 52 723 75 45 firstname.lastname@example.org|
|Principal Investigator: Volker Viereck, Prof. Dr.|
|Sub-Investigator: Oliver Rautenberg, Dr. med.|
|Principal Investigator:||Volker Viereck, Prof. Dr.||Cantonal Hospital, Frauenfeld|