TReating Incontinence for Underlying Mental and Physical Health (TRIUMPH)

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status and phase

Enrolling
Phase 4

Conditions

Incontinence, Urge
Incontinence, Urinary
Urinary Incontinence, Urge
Urinary Incontinence
Incontinence
Overactive Bladder

Treatments

Drug: Mirabegron
Drug: Tolterodine Tartrate ER
Drug: Placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05362292
1R01AG075471-01 (U.S. NIH Grant/Contract)
21-35858

Details and patient eligibility

About

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.

Enrollment

270 estimated patients

Sex

Female

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

270 participants in 3 patient groups, including a placebo group

Anticholinergic bladder medication plus behavioral self-management education
Active Comparator group
Description:
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.
Treatment:
Drug: Tolterodine Tartrate ER
Beta-3-adrenergic agonist medication plus behavioral self-management education
Active Comparator group
Description:
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.
Treatment:
Drug: Mirabegron
Placebo medication plus behavioral self-management education
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo

Trial contacts and locations

2

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Central trial contact

Alison Huang, MD, MAS, MPhil; Ann Chang

Data sourced from clinicaltrials.gov

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