Overview

This trial is active, not recruiting.

Condition stress urinary incontinence
Sponsor Cantonal Hospital, Frauenfeld
Start date May 2013
End date January 2017
Trial size 100 participants
Trial identifier NCT02785016, TVT 3D

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Females with stress urinary incontinence, who undergo a tension free surgical sling procedure.

Primary Outcomes

Measure
Cure/improvement rate
time frame: 3 months

Secondary Outcomes

Measure
Subjective symptom assessment by visual analogue scale
time frame: 3 and 6 months
Post-Operative Pain Assessment
time frame: 1 day
Standing Cough Stress Test
time frame: baseline, 3 and 6 months
King Health Questionnaire
time frame: pre-operation, 3 and 6 months
International Consultation on Incontinence Questionnaire
time frame: pre-operation, 3 and 6 months

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Prospective, Non-Randomized, Observational Trial of the Surgical Management for Suburethral Slings in Women With Stress Urinary Incontinence
Principal investigator Volker Viereck, Physican
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Cantonal Hospital, Frauenfeld.