Prospective Study of the sensiTVT (sensiTVT)

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.

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: sensiTVT

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 Due to the recent FDA announcements several tapes have been withdrawn from the market and several new ones have been designed.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 Type: Observational
• Enrollment (Estimated): 197

Contacts and Locations

• Study Contact: Name: Daniela Gold (prev. Ulrich), MD PhD; Phone Number: 81437 0043316385; Email: daniela.gold@medunigraz.at

Study Locations

• Austria
  • Graz, Austria, 8045
    • Recruiting
    • Department of Obstetrics, Medical University Graz
    • Principal Investigator: Daniela Gold, M.D.
    • Sub-Investigator: Karl Tamussino, MD
    • Sub-Investigator: Gerda Trutnovsky, MD
    • Contact: Daniela Gold (prev. Ulrich), MD, PhD; Phone Number: +4331638581437; Email: daniela.gold@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

women with stress urinary incontinence (SUI)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: Medical University Innsbruck
• Investigators: Principal Investigator: Daniela Gold (prev. Ulrich), MD PhD, Universitätsklinik für Frauenheilkunde und Geburtshilfe

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Estimated): April 2, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: July 5, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Stress urinary incontinence; objective outcome
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 29-481 ex 16/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No