Prospective Study of the sensiTVT

Medical University of Graz

Status: Terminated

Conditions: Stress Urinary Incontinence

Treatments: Device: sensiTVT

Study type: Observational

Funder types: Other

Identifiers

NCT03603535

29-481 ex 16/17

Details and patient eligibility

About

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

Full 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 Due to the recent FDA announcements several tapes have been withdrawn from the market and several new ones have been designed.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.

Enrollment: 35 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Planned surgery for verified predominant stress urinary incontinence
• women between 18 and 80 years of age
• good German language skills
• informed consent

Exclusion criteria:

• Pregnant or lactating women
• Active surgical treatment for invasive malignant diseases within 3 months
• Contraindications for surgery or anesthesia
• Severe neurologic disease
• Concomitant prolapse surgery