Surgical Management for Suburethral Slings

Stress Urinary Incontinence Clinical Trial

Official title:

Prospective, Non-Randomized, Observational Trial of the Surgical Management for Suburethral Slings in Women With Stress Urinary Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02785016
• Other study ID #: TVT 3D
• Status: Recruiting
• Start date: May 2013
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: Cantonal Hospital, Frauenfeld
• Contact: Volker Viereck, Physican
• Phone: ++41 52 723 70 50
• Email: volker.viereck[@]stgag.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Locations

Country	Name	City	State
Switzerland	Blasenzentrum, Cantonal Hospital	Frauenfeld	Thurgau

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital, Frauenfeld

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Subjective symptom assessment by visual analogue scale	Scale: 0-10 (0-no suffering, 10-severe suffering)	3 and 6 months
Secondary	Post-Operative Pain Assessment	Scale: 0-10 (0-no pain, 10-severe pain)	1 day
Secondary	Standing Cough Stress Test	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.	baseline, 3 and 6 months
Secondary	King Health Questionnaire		pre-operation, 3 and 6 months
Secondary	International Consultation on Incontinence Questionnaire		pre-operation, 3 and 6 months