Treatment of Incontinence Without Memory Problems

NCT02436889 | Completed Phase 4 Results DMC

• 1 other identifier: 14-15553
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Urge Incontinence; Urinary Incontinence, Urge

Outcome Measures

Primary Outcomes (1)

• The Number of Participants Who Completed and Discontinued the Study

  Feasibility - Assessment of retention rates.

  Baseline to Week 8

Secondary Outcomes (5)

• Change From Baseline in California Verbal Learning Test (CVLT) Score at 8 Weeks

  Baseline to Week 8

• Change From Baseline in Trail Making Test, Trail A Score at 8 Weeks

  Baseline and 8 weeks

• Change From Baseline in Short Physical Performance Battery (SPPB) Score at 8 Weeks

  Baseline to Week 8

• Change From Baseline in Total Urinary Incontinence Frequency Measured by a Voiding Diary at 8 Weeks

  Baseline to Week 8

• Change From Baseline in Urge Incontinence Episodes Per Day on a Voiding Diary at 8 Weeks.

  Baseline and 8 weeks

Study Arms (2)

Mirabegron

EXPERIMENTAL

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

Tolterodine Tartrate

ACTIVE COMPARATOR

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

Interventions

Mirabegron DRUG

Also known as: Myrbetriq

Mirabegron

Tolterodine Tartrate DRUG

Also known as: Detrol LA

Tolterodine Tartrate

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Interventions

mirabegron; Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Results Point of Contact

• Title: Alison Huang, MD
• Organization: University of California, San Francisco

alison.huang@ucsf.edu

415-514-8697

Study Officials

• Leslee Subak, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of General Internal Medicne; Epidemiology & Biostatistics; Urology

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 7, 2015
• Study Start: February 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: July 1, 2018
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-03

Locations

US (1)