Prospective Study of the sensiTVT

Terminated

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT03603535
• Lead Sponsor: Medical University of Graz

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 Due to the recent FDA announcements several tapes have been withdrawn from the market and several new ones have been designed.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

Study Timeline

• Study First Submitted: 2018-07-05
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-27
• Study Start: 2018-10-08
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
objective success of stress urinary incontinence	one year	determined by a standardized cough stress test at 300 ml bladder, a negative cough stress test is a success.

Secondary Outcome Measures

Name	Time	Method
Peri- and postoperative complications	3 months+ one year	any surgical complications recorded
Subjective incontinence cure rate using the Incontinence Outcome Questionnaire	3 months+ one year	The Incontinence Outcome Questionnaire was validated for postoperative assessment of quality of life after surgical treatment for stress urinary incontinence and has 27 items with lower scores indicating worse treatment outcome. The total score is calculated.
Patient satisfaction measured using a visual analogue scale	3 months+ one year	Patient satisfaction is defined as a score 8 to 10 on a 10-point visual analogue scale
De novo urgency	3 months+ one year	De novo OAB- overactive bladder as determined by clinical history taking
Sexual health using the Pelvic Organ Prolapse Incontinence Sexual Questionnaire	3 months+ one year	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire is a 20 item questionnaire and is the primary measure used to assess sexual function in women with urinary incontinence and prolapse. Mean subscale scores are calculated by summing the valid responses to items in the subscale and then divided by the number of items with valid responses. The higher the subscores, the worse the outcome.
Subjective success as determined using the Patient Global Impression of Improvement questionnaire.	3 months+ one year	defined as very much improved/much improved (1,2) on the Patient Global Impression of Improvement scale, while any other response (improved, same, worse, or much worse- 3-7) will be considered as failures.; The Patient Global Impression of Improvement is a seven item scale validated for incontinence.
quality of life using the Kings Health Questionnaire	3 months+ one year	The Kings Health Questionnaire was validated in women with stress urinary incontinence and assesses the impact of incontinence on quality of life. The eight subscales ("domains") scored between 0 (best) and 100 (worst). The Symptom Severity scale is scored from 0 (best) to 30 (worst); lower scores indicate better QoL. Success in terms of the study is defined as 10 points improvement on the total Kings Health Questionnaire score.
Subjective bother using the Patient Global Impression of Severity	3 months+ one year	Patient Global Impression of Severity The Patient Global Impression of Severity is a 7-item urinary symptom severity scale that is used to rate the severity of a specific condition -a single-state scale. The higher the number the worse the outcome of subjective bother of stress urinary incontinence.
Reoperation rate	3 months+ one year	Reoperation rate
Erosion rate	3 months+ one year	Erosion rate from the tape in the vagina or bladder
De novo pain in the operated region	3 months+ one year	De novo pain in the operated region as determined by clinical history taking

Trial Locations

Locations (1)

Department of Obstetrics, Medical University Graz; 🇦🇹 Graz, Austria