Urethral Length Measurement in Women Undergoing Suburethral Sling Operative Procedure

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

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence

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 Type: Observational
• Enrollment (Actual): 188

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women who have surgically-correctable stress urinary incontinence and undergo a suburethral sling operative procedure.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Stress urinary incontinence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cantonal Hospital, Frauenfeld
• Investigators: Principal Investigator: Volker Viereck, Prof. Dr., Cantonal Hospital, Frauenfeld

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: August 6, 2012
• First Submitted That Met QC Criteria: August 6, 2012
• First Posted (Estimate): August 8, 2012

Study Record Updates

• Last Update Posted (Estimate): May 20, 2016
• Last Update Submitted That Met QC Criteria: May 19, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Stress urinary incontinence; Suburethral sling
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: TVT 112010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED