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Treatment of Incontinence Without Memory Problems (TRIUMPH)

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ClinicalTrials.gov Identifier: NCT02436889
Recruitment Status : Active, not recruiting
First Posted : May 7, 2015
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Leslee Subak, University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urge Incontinence Urinary Incontinence, Urge Drug: Mirabegron Drug: Tolterodine Tartrate Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mirabegron
Participants will be instructed to take one tablet and 1 capsule (total of 2) of blinded study medication once a day, orally, for 8 weeks. They will start with Mirabegron (25mg) dose of study medication and will have the option of dose escalation to 2 tablets and 2 capsules (total of 4) per day (Mirabegron 50mg).
Drug: Mirabegron
Other Name: Myrbetriq

Active Comparator: Tolterodine Tartrate
Participants will be instructed to take one tablet and 1 capsule (total of 2) of blinded study medication once a day, orally, for 8 weeks. They will start with tolterodine tartrate (4 mg) dose of study medication and will have the option of dose escalation to 2 tablets and 2 capsules (total of 4) per day tolterodine tartrate 4 mg + identical placebo.
Drug: Tolterodine Tartrate
Other Name: Detrol LA




Primary Outcome Measures :
  1. Feasibility - Assessment of Recruitment and Retention Rates [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. Cognitive performance will be measured by standardized neuropsychologic tests [ Time Frame: Baseline to Week 8 ]
  2. Physical function/mobility will be measured with Short Physical Performance Battery (SPPB) [ Time Frame: Baseline to Week 8 ]
  3. Urinary Incontinence frequency measured by a voiding diary [ Time Frame: Baseline to Week 8 ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Alcohol and/or any other drug abuse in the opinion of the investigator.
  • Participants who have any medical (including known history of major hematological, renal, cardiovascular, or hepatic abnormalities) or psychological condition or social circumstances that would impair their ability to participate reliably in the trial, or those who may increase the risk to themselves or others by participating.
  • Participants who, in the opinion of the investigator, are not likely to complete the trial for whatever reason.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436889


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Leslee Subak, MD University of California, San Francisco

Responsible Party: Leslee Subak, Professor of Ob/Gyn & Reproductive Sciences; Epidemiology & Biostatistics; Urology, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02436889     History of Changes
Other Study ID Numbers: 14-15553
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Urge
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Mirabegron
Tolterodine Tartrate
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents