Prospective Study of the sensiTVT

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 Due to the recent FDA announcements several tapes have been withdrawn from the market and several new ones have been designed.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

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

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: sensiTVT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective success of stress urinary incontinence | determined by a standardized cough stress test at 300 ml bladder, a negative cough stress test is a success. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective success as determined using the Patient Global Impression of Improvement questionnaire. | 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. | 3 months+ one year | 
| Peri- and postoperative complications | any surgical complications recorded | 3 months+ one year | 
| Subjective incontinence cure rate using the Incontinence Outcome Questionnaire | 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. | 3 months+ one year | 
| quality of life using the Kings Health Questionnaire | 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. | 3 months+ one year | 
| Subjective bother using the Patient Global Impression of Severity | 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. | 3 months+ one year | 
| Patient satisfaction measured using a visual analogue scale | Patient satisfaction is defined as a score 8 to 10 on a 10-point visual analogue scale | 3 months+ one year | 
| Sexual health using the Pelvic Organ Prolapse Incontinence Sexual Questionnaire | 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. | 3 months+ one year | 
| Erosion rate | Erosion rate from the tape in the vagina or bladder | 3 months+ one year | 
| Reoperation rate | Reoperation rate | 3 months+ one year | 
| De novo urgency | De novo OAB- overactive bladder as determined by clinical history taking | 3 months+ one year | 
| De novo pain in the operated region | De novo pain in the operated region as determined by clinical history taking | 3 months+ one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress urinary incontinence, objective outcome