Clinical trial NCT03603535: Prospective Study of the sensiTVT
Official title: Prospective Study of the sensiTVT (Midurethral Sling) for the Surgical Treatment of Stress Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stress Urinary Incontinence
Keywords: Stress urinary incontinence
objective outcome
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
First posted: 2018-07-27
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with stress urinary incontinence (SUI)

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 Due to the recent FDA announcements several tapes have been withdrawn from the market and several new ones have been designed.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

Eligibility 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

Primary outcomes:
measure: objective success of stress urinary incontinence
timeFrame: one year
Secondary outcomes:
measure: Subjective success as determined using the Patient Global Impression of Improvement questionnaire.
timeFrame: 3 months+ one year
measure: Peri- and postoperative complications
timeFrame: 3 months+ one year
measure: Subjective incontinence cure rate using the Incontinence Outcome Questionnaire
timeFrame: 3 months+ one year
measure: quality of life using the Kings Health Questionnaire
timeFrame: 3 months+ one year
measure: Subjective bother using the Patient Global Impression of Severity
timeFrame: 3 months+ one year
measure: Patient satisfaction measured using a visual analogue scale
timeFrame: 3 months+ one year
measure: Sexual health using the Pelvic Organ Prolapse Incontinence Sexual Questionnaire
timeFrame: 3 months+ one year
measure: Erosion rate
timeFrame: 3 months+ one year
measure: Reoperation rate
timeFrame: 3 months+ one year
measure: De novo urgency
timeFrame: 3 months+ one year
measure: De novo pain in the operated region
timeFrame: 3 months+ one year
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Obstetrics, Medical University Graz
Study officials:
affiliation: Universitätsklinik für Frauenheilkunde und Geburtshilfe
name: Daniela Gold (prev. Ulrich), MD PhD
role: PRINCIPAL_INVESTIGATOR
References: