Clinical trial NCT01660438: Urethral Length Measurement in Women Undergoing Suburethral Sling Operative Procedure
Official title: Prospective, Non-randomized, Observational Study of the Surgical Management of Suburethral Slings in Women With Stress Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Keywords: Stress urinary incontinence
Suburethral sling
Lead sponsor: Cantonal Hospital, Frauenfeld
Sponsor class: OTHER
First posted: 2012-08-08
Enrollment: 188
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who have surgically-correctable stress urinary incontinence and undergo a suburethral sling operative procedure.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cure rate
timeFrame: 3 months
Secondary outcomes:
measure: Pelvic floor sonography
timeFrame: Pre-operation, day 1 and 3 months
measure: Residual urine
timeFrame: Pre-operation, day 1 and 3 months
measure: Pad test
timeFrame: Pre-operation and 3 months
measure: Urethral length measurement
timeFrame: Intra-operation
Other outcomes:
Locations:
city: Hagen
country: Germany
facility: Department of Gynecology and Obstetrics, Lutheran Hospital Hagen-Haspe
city: Lodz
country: Poland
facility: Szpital im M. Madurowicza
city: Frauenfeld
country: Switzerland
facility: Blasenzentrum, Cantonal Hospital
state: Thurgau
Study officials:
affiliation: Cantonal Hospital, Frauenfeld
name: Volker Viereck, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: