Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03603535
Other study ID # 29-481 ex 16/17
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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 Due to the recent FDA announcements several tapes have been withdrawn from the market and several new ones have been designed.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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04829357 - Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
Completed NCT05493735 - Lidocaine for Pessary Check Pain Reduction Phase 3
Completed NCT04512053 - A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence Phase 2
Active, not recruiting NCT06224335 - Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)
Recruiting NCT05304312 - The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women N/A
Not yet recruiting NCT05527665 - Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
Not yet recruiting NCT04558762 - Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
Withdrawn NCT02524366 - A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement N/A
Completed NCT01924728 - Efficacy of Magnetic Stimulation for Stress Urinary Incontinence N/A
Completed NCT01676662 - Solace European Confirmatory Trial N/A
Unknown status NCT01455779 - Lyrette: Renewing Continence Objective and Subjective Efficacy Study N/A
Terminated NCT01029106 - Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI) N/A
Completed NCT01770691 - Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence N/A
Completed NCT01123096 - Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence? N/A
Withdrawn NCT00573703 - Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence Phase 4
Completed NCT00234754 - Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women N/A
Completed NCT00441454 - Retropubic vs. Transobturator Tension-free Vaginal Tape N/A
Completed NCT03985345 - Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence. N/A
Active, not recruiting NCT03671694 - Laser Vaginal Treatment for SUI N/A
Completed NCT04097288 - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects Phase 1