Diseases

Stress Urinary Incontinence

Stress urinary incontinence affects up to 35 percent of women in the United States

Stress urinary incontinence (SUI) is a serious condition where the unintentional leakage of urine occurs during normal daily activities with increased abdominal pressure (such as coughing, sneezing, running or lifting heavy objects). This inability to control urine flow occurs when the involved sphincter and support muscles become weak or do not function properly. Women suffer more frequently from SUI because the most common causes include childbirth or other injury to the short urethral area. SUI, the most common type of incontinence suffered by women, can occur in young women after childbirth, but becomes more prevalent around the time of menopause in women. Click here to learn more about the various approaches to treating SUI in women.

The muscles responsible for SUI have a high number of androgen receptors and are responsive to the body’s hormonal status. Enobosarm (GTx-024, Ostarine®) has been shown to increase muscle mass in other settings, such as muscle wasting, or cachexia.

The goal of the SUI program is to reduce involuntary or unintentional leakage of urine in post-menopausal women. GTx has completed two clinical trials in women with SUI. The first was a single-arm, open-label Phase 2 proof-of-concept clinical trial, results from which were positive. The proof-of-concept trial results demonstrated that a daily dose of enobosarm 3 mg substantially improved SUI in women, as well as related quality of life measurements. The second was a randomized, placebo-controlled Phase 2 clinical trial, referred to as ASTRID, to further evaluate enobosarm’s ability to decrease stress incontinence episodes and improve quality of life in women with SUI. The ASTRID trial did not achieve statistically significant reductions in stress leaks per day compared to placebo.

Treatment of Stress Urinary Incontinence

There are a variety of approaches to treating SUI in women. They are listed below in the order in which they are usually implemented as the disease progresses in severity.

  • Behavior modification
  • Pelvic floor physical therapy
  • Medications
    There are currently no approved therapies indicated for the treatment of SUI
  • Surgery
    Artificial urinary sphincter or male sling (males);
    Bulking injections around the urethra;
    Repair of vaginal prolapse;
    Suspensions to lift the bladder and urethra;
    Tension-free vaginal tape supports the bladder and urethra;
    and Vaginal sling to support the urethra