Stress Urinary Incontinence Clinical Trial
— sensiTVTOfficial title:
Prospective Study of the sensiTVT (Midurethral Sling) for the Surgical Treatment of Stress Urinary Incontinence
sensiTVT is a relatively new tape. The aim of this study is to analyze the objective and subjective outcome at one year follow-up.
Status | Recruiting |
Enrollment | 197 |
Est. completion date | September 30, 2025 |
Est. primary completion date | April 2, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Department of Obstetrics, Medical University Graz | Graz |
Lead Sponsor | Collaborator |
---|---|
Medical University of Graz | Medical University Innsbruck |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Peri- and postoperative complications | any surgical complications recorded | 3 months+ one year | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Erosion rate | Erosion rate from the tape in the vagina or bladder | 3 months+ one year | |
Secondary | Reoperation rate | Reoperation rate | 3 months+ one year | |
Secondary | De novo urgency | De novo OAB- overactive bladder as determined by clinical history taking | 3 months+ one year | |
Secondary | De novo pain in the operated region | De novo pain in the operated region as determined by clinical history taking | 3 months+ one year |
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