NCT03603535

Prospective Study of the sensiTVT

Prospective Study of the sensiTVT (Midurethral Sling) for the Surgical Treatment of Stress Urinary Incontinence

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

sensiTVT is a relatively new tape. The aim of this study is to analyze the objective and subjective outcome at one year follow-up.

Detailed description

Stress urinary incontinence (SUI) is defined as the involuntary leakage during physical activity and situations that result in an increase of abdominal pressure like sneezing, coughing or laughing and affects up to 25% of women. Currently there are a number of tapes on the market with GYNECARE TVT EXACT® (Tension free Vaginal Tape) and TVT- Obturator being one of the tapes with the highest subjective and objective cure rates and relatively low adverse events in women with normal sphincter pressure. Due to the recent FDA announcements several tapes have been withdrawn from the market and several new ones have been designed. Data from other tapes are available, however data especially from newer tapes is lacking.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	sensiTVT	The study is designed as a prospective single arm study. All women with an indication for suburethral tape placement for therapy of SUI and meeting the inclusion criteria will be offered study participation to record the objective outcome after one year.

Timeline

• Start date: 2018-10-08
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2018-07-27
• Last updated: 2025-02-28

Locations

1 site across 1 country: Austria