Prospective Study of the sensiTVT

Stress Urinary Incontinence Clinical Trial

— sensiTVT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03603535
• Other study ID #: 29-481 ex 16/17
• Status: Recruiting
• Start date: October 8, 2018
• Est. completion date: September 30, 2025

Study information

• Verified date: January 2024
• Source: Medical University of Graz
• Contact: Daniela Gold (prev. Ulrich), MD PhD
• Phone: 0043316385
• Email: daniela.gold[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 Due to the recent FDA announcements several tapes have been withdrawn from the market and several new ones have been designed.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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.

Locations

Country	Name	City	State
Austria	Department of Obstetrics, Medical University Graz	Graz

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

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