Treatment of Incontinence Without Memory Problems

Completed · Phase 4

Conditions studied: Urge Incontinence, Urinary Incontinence, Urge

In brief

An 8-week randomized, controlled, pilot clinical trial of Mirabegron compared to a standard anticholinergic therapy (Detrol LA) in elderly women with urgency urinary incontinence.

Key facts

Study ID

NCT02436889

Run by

University of California, San Francisco

People needed

23

Starts

2016-02-01

Expected to finish

2018-07-01

Last updated by the study team

2019-04-16

Who can join

Age: 65 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Community-dwelling, ambulatory females ≥ 65 years old
• Urgency or Mixed Urgency Predominate Urinary Incontinence (subject-reported) for ≥ 3 months prior to Screening (Visit 1)
• On a 3-day voiding diary, documentation of at least 3 urgency incontinence episodes with the number of urgency incontinence episodes greater than number of stress incontinence episodes
• Capability of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risk and benefits
• Ability to perform all procedures and tests required by the protocol
• Report having a primary health care provider
• Willingness to remain on stable medication regime for duration of the randomized controlled trial. Participants will be asked to not add new medications during the randomized controlled trial, such as diuretics and other medications which may affect their voiding pattern.

You may not qualify if…

• Seated blood pressure >180/110 at Screening or Baseline
• Physician diagnosis of dementia
• Current use of dementia medications, debilitating or recent neurologic disease
• Mini Mental State Examination (MMSE) score <20
• History of urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe ulcerative colitis, toxic megacolon, fistula or a hole in your bladder or rectum, birth defect leading to urine leakage, and urine leakage starting in childhood
• Clinically significant hepatic (Child Pugh B or greater) or renal (creatinin clearance <30 mL/min or eGFR <30 mL/min/1.73 m2)
• Neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease.
• Major cardiovascular even in the past 6 months (i.e., MI, unstable angina, hospitalization for chest pain)
• Symptomatic pelvic organ prolapse defined as participant report of feeling or seeing a bulge outside the vagina within the past 3 months.
• History of surgery for incontinence in the past 5 years, pelvic surgery the past 6 months (i.e., for prolapse or hysterectomy), intra-vesical therapy (botox), and/or bulk injections within the past 6 months.
• A known history of interstitial cystitis or a significant pain component associated with OAB symptoms, uninvestigated hematuria, urogenital cancer, radiation to the pelvis or external genitalia.
• Urinary tract infection (UTI) as shown by the results of the urinalysis at screening or recurrent urinary tract infection (RUTIs) defined as treatment for UTI >3 times in the last year.
• Urinary retention (post-void residual urine volume >150 cc measured by Bladder scan at screening.
• Use of any electrostimulation, bladder training, or pelvic floor exercises (with certified incontinence practitioners) within 4 weeks of Screening.
• Received study medication in any previous mirabegron clinical trial.
• Prior failure for either efficacy or tolerability of ≥ 2 OAB medications in the last year. (Failure: inadequate symptom control after two medications for a minimum of one month each.)
• Has been treated within 2 weeks prior to Screening and/or is currently being treated with:
• Any drug treatment for OAB
• Any drugs with significant anticholinergic and antispasmodic effects (see exception for tricyclic antidepressants below)
• Has started treatment with tricyclic antidepressants or estrogens within 4 weeks prior to Screening and/or is not on a stable dose.
• Intermittent use or unstable dose of diuretics. Treatment with diuretics initiated within 2 weeks prior to baseline and/or is not on a stable dose is not permitted.
• Treatment with potent CYP3A4 inhibitors, such as clarithromycin, ketoconazole, and itraconazole within 2 weeks prior to Screening.
• Administration of medications capable of inducing hepatic enzyme metabolism or transport (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John's Wort) in the past 30 days.
• Administration of narrow therapeutic index drugs metabolized by CYP2D6, such as thioridazine, flecainide, and propafenone.
• Previously received any investigational drug within 30 days prior to trial entry.

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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