ClinicalTrials.Veeva

Menu

Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence (SISTEr)

C

Carelon Research

Status and phase

Completed
Phase 3
Phase 2

Conditions

Urinary Incontinence

Treatments

Procedure: Autologous Fascia Sling
Procedure: Burch Modified Tanagho

Study type

Interventional

Funder types

Other

Identifiers

NCT00064662
UITN-RCT (completed)

Details and patient eligibility

About

The primary aim of this clinical trial is to compare the treatment success for two surgical procedures that are frequently used and have similar cure rates, yet have not been compared directly to each other in a large, rigorously conducted randomized trial. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and need for other treatment(s)after surgery. Follow-up will be a minimum of two years and up to four years.

Enrollment

655 patients

Sex

Female

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

  • Predominant stress urinary incontinence by self-report,examination and test;
  • Urethral hypermobility;
  • Eligible for both surgical procedures;
  • Ambulatory;
  • Not pregnant;
  • >12 months post-partum;
  • No systemic disease known to affect bladder function;
  • No current chemotherapy or radiation therapy;
  • No urethral diverticulum, augmentation cytoplasty, or artificial sphincter;
  • No recent pelvic surgery;
  • Available for follow-up and able to complete study assessments;
  • Signed informed consent.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

655 participants in 2 patient groups

Burch
Other group
Description:
The Burch colposuspension
Treatment:
Procedure: Burch Modified Tanagho
Sling
Other group
Description:
Pubovaginal sling, using autologous rectus fascia
Treatment:
Procedure: Autologous Fascia Sling

Trial contacts and locations

9

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems