Prospective Study of the sensiTVT
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Due to the recent FDA announcements several tapes have been withdrawn from the market and several new ones have been designed.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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
- 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
- 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.
- Erosion rate [3 months+ one year]
Erosion rate from the tape in the vagina or bladder
- Reoperation rate [3 months+ one year]
Reoperation rate
- De novo urgency [3 months+ one year]
De novo OAB- overactive bladder as determined by clinical history taking
- De novo pain in the operated region [3 months+ one year]
De novo pain in the operated region as determined by clinical history taking
Eligibility Criteria
Criteria
Inclusion criteria
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Planned surgery for verified predominant stress urinary incontinence
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women between 18 and 80 years of age
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good German language skills
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informed consent
Exclusion criteria:
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Pregnant or lactating women
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Active surgical treatment for invasive malignant diseases within 3 months
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Contraindications for surgery or anesthesia
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Severe neurologic disease
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Concomitant prolapse surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Obstetrics, Medical University Graz | Graz | Austria | 8045 |
Sponsors and Collaborators
- Medical University of Graz
- Medical University Innsbruck
Investigators
- Principal Investigator: Daniela Gold (prev. Ulrich), MD PhD, Universitätsklinik für Frauenheilkunde und Geburtshilfe
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 29-481 ex 16/17