Urethral Length Measurement in Women Undergoing Suburethral Sling Operative Procedure

NCT01660438 | Completed DMC

• 1 other identifier: TVT 112010
• Study Type: observational
• Target: 188
• Locations: 3 countries
• Sites: 3

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.

Conditions

Stress Urinary Incontinence

Keywords

Stress urinary incontinence; Suburethral sling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  Intra-operation

Study Arms (1)

Stress urinary incontinence

Stress urinary incontinence

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.
• Patient is age 18 or older.
• 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.
• Patient is able to fill in all questionnaires (based on judgment of investigator)

You may not qualify if:

• Patient has an associated or suspected neurological disease.
• Patient has an active lesion or present injury to perineum or urethra.
• Patient has a urethral obstruction.
• Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
• Patient has current urinary tract infection.

Sponsors & Collaborators

• Cantonal Hospital, Frauenfeld: lead

Study Sites (3)

Department of Gynecology and Obstetrics, Lutheran Hospital Hagen-Haspe

Hagen, Germany

Location

Szpital im M. Madurowicza

Lodz, Poland

Location

Blasenzentrum, Cantonal Hospital

Frauenfeld, Thurgau, Switzerland

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Volker Viereck, Prof. Dr.

  Cantonal Hospital, Frauenfeld

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Volker Viereck

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: August 8, 2012
• Study Start: August 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 20, 2016

Record last verified: 2016-05

Locations

PL (1); DE (1); CH (1)