Surgical Management for Suburethral Slings

NCT02785016 | Completed DMC

• 1 other identifier: TVT 3D
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, non-randomized, observational, single center study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a suburethral sling operative procedure.

Conditions

Stress Urinary Incontinence

Keywords

Stress Urinary Incontinence; Suburethral Sling

Outcome Measures

Primary Outcomes (1)

• Cure/improvement rate

  Patients are classified as cured if the postoperative cough test (see Outcome 4 below) is negative and the degree of subjective suffering (see Outcome 2 below) improves to over 90% (VAS score of 0 or 1). Criteria for improvement are involuntary loss of only a few drops of urine during straining and an improvement of the degree of suffering to over 75% (VAS score of 2 or 3). All other patients are classified as therapeutic failures (even if they show marked improvement of one of the parameters compared with their preoperative status).

  3 months

Secondary Outcomes (5)

• Subjective symptom assessment by visual analogue scale

  3 and 6 months

• Post-Operative Pain Assessment

  1 day

• Standing Cough Stress Test

  baseline, 3 and 6 months

• King Health Questionnaire

  pre-operation, 3 and 6 months

• International Consultation on Incontinence Questionnaire

  pre-operation, 3 and 6 months

Study Arms (1)

Stress Urinary Incontinence

Females with stress urinary incontinence, who undergo a tension free surgical sling procedure.

Eligibility Criteria

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

Study Population

Subjects that 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 IRB/EC-approved informed consent.
• Patient is able to fill in all questionnaires (on judgement 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.
• The subject has current urinary tract infection.

Sponsors & Collaborators

• Cantonal Hospital, Frauenfeld: lead

Study Sites (1)

Blasenzentrum, Cantonal Hospital

Frauenfeld, Thurgau, 8501, 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, Physican

  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.

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 27, 2016
• Study Start: May 1, 2013
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

CH (1)