Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Burch Modified Tanagho, Autologous Fascia Sling · 1 trial · 1 indication
Success defined as composite measure including: no self-reported incontinence symptoms reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire, \<15g in pad weight during 24 hr pad test, no incontinence episodes on 3-day voiding diary, negative results (no leakage) on provocative stress test at standardized bladder volume, no retreatment for urinary incontinence. Additional treatment for stress urinary incontinence (SUI) includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI.
Stress-specific success defined by composite measure including: no self-reported symptoms of stress incontinence reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire , negative results (no leakage) on a provocative stress test at standardized bladder volume and no retreatment for stress incontinence Additional treatment for SUI includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI.
| Arm | Type | Description |
|---|---|---|
| Burch | OTHER | The Burch colposuspension |
| Sling | OTHER | Pubovaginal sling, using autologous rectus fascia |
| Name | Type | Description |
|---|---|---|
| Burch Modified Tanagho | PROCEDURE | The Burch colposuspension is a well-established procedure for surgically treating women with stress urinary incontinence. The Burch modified colposuspension suspends the anterior vaginal wall (at the level of the bladder neck) with permanent sutures tied to the iliopectineal ligament. |
| Autologous Fascia Sling | PROCEDURE | The fascial sling is also a well-established procedure for surgically treating women with stress urinary incontinence. The autologous sling procedure places a harvested strip of rectus fascia transvaginally at the level of the proximal urethra. The fascial strip is secured superiorly to the rectus fascia with permanent sutures |
* 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 th...
Burch Modified Tanagho, Autologous Fascia Sling is used for urinary incontinence. It is an investigational surgical procedure being studied in a Phase 2 clinical trial that compares surgical approaches to reduce stress urinary incontinence in women.
Burch Modified Tanagho, Autologous Fascia Sling is being developed by Elevance Health, Inc., which trades under the ticker ELV. The company is conducting clinical research on this surgical procedure for urinary incontinence.
Burch Modified Tanagho, Autologous Fascia Sling is in Phase 2 clinical development. It is an investigational procedure, not yet approved, and is being evaluated in a completed Phase 2 trial for urinary incontinence.
Burch Modified Tanagho, Autologous Fascia Sling is studied in clinical trial NCT00064662, titled "Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence." This Phase 2 trial enrolled 655 female participants aged 21 years and older in the United States.
Burch Modified Tanagho, Autologous Fascia Sling is a surgical procedure that uses autologous fascia, meaning tissue taken from the patient's own body, to create a sling. It is being compared with other surgical procedures in a clinical trial for stress urinary incontinence.