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

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)

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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