Last updated: March 6, 2024
Sponsor: Cantonal Hospital, Frauenfeld
Overall Status: Active - Recruiting
Phase
N/A
Condition
Enuresis
Urinary Incontinence
Treatment
N/AClinical Study ID
NCT02785016
TVT 3D
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient has objective demonstrable signs of stress urinary incontinence (SUI),including patients with intrinsic sphincter deficiency (ISD). Objective testingincludes: 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-relatedprocedures and evaluations, and documents this agreement by signing theIRB/EC-approved informed consent.
- Patient is able to fill in all questionnaires (on judgement of investigator)
Exclusion
Exclusion Criteria:
- 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 surgicaltreatment.
- The subject has current urinary tract infection.
Study Design
Total Participants: 100
Study Start date:
May 01, 2013
Estimated Completion Date:
July 31, 2025
Study Description
Connect with a study center
Blasenzentrum, Cantonal Hospital
Frauenfeld, Thurgau 8501
SwitzerlandActive - Recruiting
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