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Surgical Management for Suburethral Slings

C

Cantonal Hospital, Frauenfeld

Status

Enrolling

Conditions

Stress Urinary Incontinence

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Stress Urinary Incontinence
Description:
Females with stress urinary incontinence, who undergo a tension free surgical sling procedure.

Trial contacts and locations

1

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Central trial contact

Oliver Rautenberg, Physican; Volker Viereck, Physican

Data sourced from clinicaltrials.gov

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