Surgical Management for Suburethral Slings

NCT ID: NCT02785016

Last Updated: 2024-03-07

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

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2025-07-31

Brief Summary

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This is a prospective, non-randomized, observational, single center study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a suburethral sling operative procedure.

Detailed Description

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The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires. Intraoperative procedural data will be collected.

Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals. The anatomic position of the device will be characterize by introital ultrasound testing.

Conditions

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Stress Urinary Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stress Urinary Incontinence

Females with stress urinary incontinence, who undergo a tension free surgical sling procedure.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with intrinsic sphincter deficiency (ISD). Objective testing includes: standing stress test, urodynamics evaluation, or pad test.
2. Patient is age 18 or older.
3. Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the IRB/EC-approved informed consent.
4. Patient is able to fill in all questionnaires (on judgement of investigator)

Exclusion Criteria

1. Patient has an associated or suspected neurological disease.
2. Patient has an active lesion or present injury to perineum or urethra.
3. Patient has a urethral obstruction.
4. Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
5. The subject has current urinary tract infection.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cantonal Hospital, Frauenfeld

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Volker Viereck

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Volker Viereck, Physican

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital, Frauenfeld

Locations

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Blasenzentrum, Cantonal Hospital

Frauenfeld, Thurgau, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Volker Viereck, Physican

Role: CONTACT

++41 52 723 70 50

Oliver Rautenberg, Physican

Role: CONTACT

++41 52 723 77 45

Facility Contacts

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Volker VV Viereck, Physican

Role: primary

++41 52 723 70 50

Oliver OR Rautenberg, Physican

Role: backup

++41 52 723 75 45

Other Identifiers

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TVT 3D

Identifier Type: -

Identifier Source: org_study_id

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