Prospective Study of the sensiTVT

NCT ID: NCT03603535

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-08

Study Completion Date

2023-09-30

Brief Summary

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sensiTVT is a relatively new tape. The aim of this study is to analyze the objective and subjective outcome at one year follow-up.

Detailed Description

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 Due to the recent FDA announcements several tapes have been withdrawn from the market and several new ones have been designed.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

Conditions

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Stress Urinary Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniela Gold (prev. Ulrich), MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik für Frauenheilkunde und Geburtshilfe

Locations

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Department of Obstetrics, Medical University Graz

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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29-481 ex 16/17

Identifier Type: -

Identifier Source: org_study_id

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