Clinical trial NCT05362292: TReating Incontinence for Underlying Mental and Physical Health
Official title: Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Urinary Incontinence, Urge
Urinary Incontinence
Overactive Bladder
Incontinence, Urge
Incontinence, Urinary
Incontinence
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-05-05
Enrollment: 270
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Change in composite cognitive function over 6 months (24 weeks) of treatment, using a composite cognitive score that incorporates normalized data from all domain-specific cognitive tests.
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in composite cognitive function over 9 months (36 weeks), using a composite cognitive score that incorporates normalized data from all domain-specific cognitive tests.
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in Auditory Verbal Learning Test total learning score assessed over 6 months (24 weeks) of treatment
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in Auditory Verbal Learning Test total learning score assessed over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change Auditory Verbal Learning Test delayed free recall score over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change Auditory Verbal Learning Test delayed free recall score over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in Oral Trail Making A score over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in Oral Trail Making A score over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in Oral Trail Making B score over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in Oral Trail Making B score over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in Digit Span reverse component (total correct trials) over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in Digit Span reverse component (total correct trials) over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in Digit Symbol Substitution Test score over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in Digit Symbol Substitution Test score over 9 months (36 weeks).
timeFrame: Baseline 9 months (3 months after end of treatment)
measure: Change in frequency of urgency-type incontinence (episodes/week) over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in frequency of urgency-type incontinence (episodes/week) over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in frequency of any-type incontinence (episodes/week) over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in frequency of any-type incontinence (episodes/week) over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Resolution of urinary incontinence from baseline to 6 months (24 weeks).
timeFrame: Baseline to 6 months (end of treatment)
measure: Resolution of urinary incontinence from baseline to 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Symptom Bother domain score over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Symptom Bother domain score over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Health-Related Quality of Life domain score over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Health-Related Quality of Life domain score over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in global sleep quality score over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in global sleep quality score over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in daytime sleepiness score over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in daytime sleepiness score over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in perceived physical function over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in perceived physical function over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in confidence in maintaining balance over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in confidence in maintaining balance over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in overall physical performance over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in overall physical performance over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in static balance over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in static balance from over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in lower extremity strength measured by chair stand testing over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in lower extremity strength measured by chair stand testing over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in depression symptoms over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in depression symptoms over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in anxiety symptoms over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in anxiety symptoms over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in constipation symptoms over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in constipation symptoms over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
measure: Change in bowel incontinence symptoms over 6 months (24 weeks) of treatment.
timeFrame: Baseline to 6 months (end of treatment)
measure: Change in bowel incontinence symptoms over 9 months (36 weeks).
timeFrame: Baseline to 9 months (3 months after end of treatment)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Alison Huang, MD, MAS, MPhil
role: PRINCIPAL_INVESTIGATOR
References: