Comparison of Burch Urethropexy and Mid-urethral Sling Performed Concomitantly With a Sacral Colpopexy

• Register: ClinicalTrials.gov
• Last refreshed on: 21 January 2013
• Main ID: NCT00934999
• Date of registration: 06/07/2009
• Primary sponsor: Mayo Clinic
• Public title: Comparison of Burch Urethropexy and Mid-urethral Sling Performed Concomitantly With a Sacral Colpopexy
• Scientific title: A Randomized Comparison of Concomitant Incontinence Procedures Performed With Abdominal Sacral Colpopexy: the Burch Versus Mid-urethral Sling Trial
• Date of first enrolment: June 2009
• Target sample size: 124
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00934999
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Emanuel C. Trabuco, MD, MS

• Name: Emanuel C. Trabuco, MD, MS

• Name: Emanuel C. Trabuco, MD, MS
• Affiliation: Mayo Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

1. older than 21 years of age;

2. with symptomatic pelvic organ prolapse (POP-Q point Aa or C at = -1 cm;

3. who have opted for sacral colpopexy repair of prolapse;

4. who have demonstrable SUI during multichannel urodynamics;

5. who have urethral hypermobility;

6. with a maximal cystometric capacity = 200 cc;

7. who are willing to return for follow-up visit; or

8. who understand and have signed written informed consent to undergo randomization and
who has given investigators permission to collect data pertaining to surgical care
and follow-up.

Exclusion Criteria:

1. with known or suspected disease that affect bladder function (i.e., multiple
sclerosis, Parkinson's Disease, spinal cord injury, etc.);

2. who are pregnant by self report or by positive pregnancy test;

3. who desire to maintain fertility;

4. with history of urethral diverticulum;

5. with a history of radical pelvic surgery or pelvic radiation therapy;

6. who are deemed medically poor candidates for abdominal surgery;

7. Non-ambulatory (including those who ambulate with assistance; or

8. who are actively undergoing chemotherapy or radiation treatment for malignancy.



Age minimum: 21 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Urinary Incontinence

Intervention(s)

Procedure: Burch urethropexy

Procedure: Synthetic mid-urethral sling (TVT)

Primary Outcome(s)

The primary endpoint is to compare the proportion of patients who are continent in each group. Continence requires negative standardized stress test performed by a masked observer; no interim re-treatment for SUI; no self reported incontinence (ISI =0) [Time Frame: 6 months]

Secondary Outcome(s)

Compare the safety of the Burch and the mid-urethral sling. [Time Frame: 6, 12 and 24 months]

The secondary endpoint is to compare the proportion of patients who have stress specific continence in each group. Stress specific continence requires: fulfilling criteria 1 and 2 above and 3) no self reported SUI specific symptoms. [Time Frame: 6 months]

To compared continence, stress specific continence and patient satisfaction between groups at 12 and 24 months. [Time Frame: 12 and 24 months]

Secondary ID(s)

07-007334

94021001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Saint Luke's Urogynecology Center

Spectrum Health Hospitals