Surgical Management for Suburethral Slings

Recruiting

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT02785016
• Lead Sponsor: Cantonal Hospital, Frauenfeld

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.

Detailed Description

The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires. Intraoperative procedural data will be collected.

Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals. The anatomic position of the device will be characterize by introital ultrasound testing.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-05-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07
• Primary Completion: 2024-12
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cure/improvement rate	3 months	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).

Secondary Outcome Measures

Name	Time	Method
Standing Cough Stress Test	baseline, 3 and 6 months	3 categories: negative/severe, if flow of urine is observed. negative/mild, if the loss of only a few drops is observed. positive, if no urine loss occurs.
International Consultation on Incontinence Questionnaire	pre-operation, 3 and 6 months
King Health Questionnaire	pre-operation, 3 and 6 months
Subjective symptom assessment by visual analogue scale	3 and 6 months	Scale: 0-10 (0-no suffering, 10-severe suffering)
Post-Operative Pain Assessment	1 day	Scale: 0-10 (0-no pain, 10-severe pain)

Trial Locations

Locations (1)

Blasenzentrum, Cantonal Hospital; 🇨🇭 Frauenfeld, Thurgau, Switzerland