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NCT05362292 | Recruiting | Urinary Incontinence, Urge


TReating Incontinence for Underlying Mental and Physical Health
Sponsor:

University of California, San Francisco

Brief Summary:

The TRIUMPH study is a randomized, double-blinded, 3-arm, parallel-group trial designed to compare the effects of anticholinergic bladder therapy versus a) beta-3-adrenergic agonist bladder therapy and b) no bladder pharmacotherapy on cognitive, urinary, and other aging-related functional outcomes in ambulatory older women with urgency-predominant urinary incontinence and either normal or mildly impaired cognitive function at baseline.

Condition or disease

Urinary Incontinence, Urge

Urinary Incontinence

Overactive Bladder

Incontinence, Urge

Incontinence, Urinary

Incontinence

Intervention/treatment

Tolterodine Tartrate ER

Mirabegron

Placebo

Phase

Phase 4

Study Type : Interventional
Estimated Enrollment : 270 participants
Masking : Triple
Primary Purpose : Treatment
Official Title : Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence
Actual Study Start Date : October 4, 2022
Estimated Primary Completion Date : September 28, 2026
Estimated Study Completion Date : December 28, 2026
Arm Intervention/treatment

Active Comparator: Anticholinergic bladder medication plus behavioral self-management education

Tolterodine tartrate is a muscarinic receptor antagonist designed to treat urgency incontinence, urgency, and frequency associated with overactive bladder. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.

Drug: Tolterodine Tartrate ER

Active Comparator: Beta-3-adrenergic agonist medication plus behavioral self-management education

Mirabegron, currently sold under the brand name Mybetriq by Astellas Pharma, is a selective beta-3-adrenergic receptor agonist approved for treatment of urgency urinary incontinence, urgency, and frequency associated with overactive bladder. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.

Drug: Mirabegron

Placebo Comparator: Placebo medication plus behavioral self-management education

Microcrystalline cellulose placebo encapsulated to appear identical to tolterodine and mirabegron medication will be prepared by a compounding pharmacy. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.

Drug: Placebo

Ages Eligible for Study: 60 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Aged 60 years or older at the time of enrollment
  • Female sex at birth, without surgical or hormonal gender re-assignment therapy
  • Able to walk to the bathroom and use the toilet without assistance
  • Report urinary incontinence starting at least 3 months prior to screening
  • Report that at least half of incontinence episodes occur with a sudden or strong sensation of urgency
  • Report 2 or more urgency incontinence episodes over a 7-day period
  • Willing to provide informed consent and adhere to study procedures throughout the length of the study
Exclusion Criteria
  • Prior clinician diagnosis of dementia, or a Montreal Cognitive Assessment (MOCA) score of 17 or lower on screening cognitive evaluation
  • Current use of anticholinergic, beta-3-adrenergic agonist, or other medication designed to improve urgency incontinence symptoms, or use in the past 1 month
  • Initiation, discontinuation, or dose change of dementia medications (such as donepezil, galantamine, memantine, rivastigmine) in the past 1 month (but candidates on stable doses are eligible)
  • Initiation, discontinuation, or dose change of other drugs with strong anticholinergic effects (based on the Beers List) in the past 1 month (but candidates on stable doses are eligible)
  • Initiation, discontinuation, or dose change of other drugs that can affect urinary frequency, including diuretics, in the past 1 month (but candidates on stable doses are eligible)
  • Current urinary tract infection (UTI) based on screening urinalysis and culture (but candidates can re-present for re-screening after undergoing treatment for UTI)
  • History of allergy or sensitivity to either of the study medications or an ingredient in the placebo or study medication capsule
  • Severe hepatic impairment (Child-Pugh score B or greater) or renal impairment (creatinine clearance <30 mL/min) as a contraindication to both study medications
  • Current bladder obstruction or urinary retention (defined by symptoms suggesting difficulty emptying the bladder in addition to postvoid residual urine volume greater than 150 cc by portable bladder ultrasound)
  • Uncontrolled hypertension (based on measured systolic blood pressure greater than 180 or diastolic blood pressure greater than 110 mmHg) as a contraindication to beta-3-adrenergic therapy
  • Self-reported history of gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe ulcerative colitis, or toxic megacolon as contraindications for anticholinergic bladder therapy
  • Use of drugs with adverse interactions with one of the study medications in the past 1 month, including potent CYP3A4 inhibitors, hepatic enzyme metabolism inducers, narrow therapeutic index drugs metabolized by CYP2D6, or intention to start taking one of these medications during the study treatment period
  • History of bladder surgery, invasive intra-vesical therapy, or bulk bladder injections in the past 3 months (more remote surgery will not be exclusionary), or intention to undergo one of these procedures in the study treatment period
  • Use of other specialized incontinence therapy (electrostimulation, pelvic physiotherapy, formal behavioral therapy overseen by certified practitioners) in the past 3 months (more remote therapy will not be exclusionary), or intention to undergo one of these procedures in the study treatment period
  • Inability to sign informed consent or complete questionnaires, interviews, or study testing in English
  • Other condition that would prevent the participant from completing study procedures, in the opinion of the investigators (e.g., uncontrolled psychosis)

TReating Incontinence for Underlying Mental and Physical Health

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TReating Incontinence for Underlying Mental and Physical Health

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Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, California

Stanford University

Palo Alto, California, United States, 94305

Recruiting

United States, California

University of California San Francisco

San Francisco, California, United States, 94115

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