Clinical trial NCT06225479: PRescription Exercise for Older Men With Urinary Disease
Official title: PRescription Exercise for Older Men With Urinary Disease (PROUD) Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Keywords: physical fitness
endurance training
resistance training
prostatism
male urogenital diseases
urinary bladder outlet obstruction
skeletal muscle
mitochondria
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, Berkeley
name: University of California, San Diego
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-01-26
Enrollment: 68
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center 2-arm pilot randomized control trial (RCT) of a 12-week remote exercise intervention and a health education control among 68 physically inactive older men with LUTS/BPH.
Primary purpose: TREATMENT

Brief summary: This is a single-center pilot randomized controlled trial among 68 physically "inactive" older men with lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (LUTS/BPH) assessing a 12-week remote exercise intervention versus health education control.

Detailed description: This study will provide valuable insights into the feasibility of an individualized, remotely-monitored, and home-based exercise intervention as well as the effect of this intervention on lower urinary tract symptom (LUTS) severity and mechanistic measures (physical function, lower urinary tract function, frailty-related mechanistic biomarkers) in a diverse group of older men with LUTS attributed to benign prostatic hyperplasia (BPH). The potential public health benefit to society in this study could be large, as the investigators are targeting a common condition in older men (one in three older men develop LUTS in their lifetime).

Eligibility criteria: Inclusion Criteria:

1. Age 60 years or older.
2. Male sex at birth.
3. Moderate-to-severe LUTS over the past month (defined as International Prostate Symptom Score \[IPSS\] \>=12).
4. A clinical diagnosis of LUTS/BPH as demonstrated by a current or prior BPH medication prescription (alpha-blocker, 5alpha-reductase inhibitor, daily phosphodiesterase type 5 inhibitor) OR untreated LUTS/BPH and a maximum urinary flow rate \<=12 ml/sec.
5. Physically inactive as defined in the Molecular Transducers of Physical Activity Consortium (MoTrPAC): no more than 1 day per week, lasting no more than 60 minutes, of regular endurance/aerobic exercise \[e.g., brisk walking, jogging, running, cycling, elliptical, or swimming activity that results in feelings of increased heart rate (HR), rapid breathing, and/or sweating\] or resistance exercise \[resulting in muscular fatigue\] in the past year). Leisure walkers are eligible unless they meet the HR, breathing, and sweating criteria.
6. Able to walk 400m without sitting, leaning, or the help of another person (observed during exercise testing) to ensure safety while exercising with remote monitoring. Use of a straight cane is allowed.
7. Able to speak and complete questionnaires in English.
8. Have an iOS or Android smartphone capable of installing the Polar Beat app.

Exclusion Criteria:

1. Prescribed overactive bladder medications (e.g., anti-muscarinics, beta-3-adrenergic agonists) \<3 months before screening.
2. Initiation, dose escalation, or weaning of BPH medications \<1 month before screening (\<6 months for 5-alpha-reductase inhibitors). Participants' must also be willing to not start, stop, or change their BPH medications for the subsequent 7 months (the entire study period).
3. Initiation, dose escalation, or weaning of other pharmacologic agents or dietary supplements that might affect LUTS (e.g., saw palmetto, testosterone, diuretics, glucose-lowering agents) \<1 month before screening. Participants' must also be willing to not start, stop, or change these medications for the subsequent 7 months (the entire study period) unless deemed necessary by their clinician.
4. History of BPH procedure or surgery.
5. History of overactive bladder procedure (e.g., intravesical Botox, sacral neuromodulation, posterior tibial nerve stimulation).
6. History of prostate cancer (treated with surgery or radiation), bladder cancer, other lower urinary tract cancer, pelvic radiation, or active non-urologic cancer treatments.
7. History of urethral strictures.
8. History of neurogenic bladder or neurologic conditions causing lower urinary tract dysfunction (e.g., Parkinson's disease, multiple sclerosis, other progressive neurological disease).
9. History of recurrent bladder or prostate infections (3 or more infections in the previous 12 months before screening).
10. History of severe or end-stage chronic kidney disease disease, kidney transplant, heart transplant, congenital heart disease, severe heart failure (defined as current New York Heart Association (NYHA) Class III or IV), valvular heart disease, diabetic coma, or the presence of a pacemaker or implantable cardiac defibrillator without clinician clearance.
11. Heart attack or myocardial infarction, heart surgery, cardiac catheterization, stroke, transient ischemic attack, brain hemorrhage, bleeding brain aneurysm, blood clot in leg or lungs, symptomatic hypoglycemia or hyperglycemia, hip fracture, or non-elective hospitalization \<6 months before screening. If conditions occurred 6 to \<12 months before screening, can participate with clinician clearance.
12. Bladder or prostate infection \<1 months before screening. If infection occurred between 1 to \<3 months before screening, can participate with clinician clearance.
13. Major surgery \<3 months before screening or scheduled in the subsequent 7 months.
14. Terminal illness diagnosis with estimated life expectancy \<12 months.
15. Plan to leave the study area for \>28 consecutive days during the subsequent 7 months.
16. Participation in formal behavioral LUTS interventions (e.g., pelvic floor physiotherapy) \<1 month before screening.
17. Symptoms of possible coronary artery disease, heart failure, arrythmia, stroke, carotid artery stenosis, valvular heart disease, blood clot in lungs, poorly controlled diabetes, peripheral vascular disease, or bladder or prostate infection without clinician clearance.
18. Maximum urinary flow rate \<=4 ml/sec OR volume voided during free flow \<120ml during screening or the baseline visit.
19. Post-void residual \>=450ml measured by ultrasound during screening or the baseline visit.
20. Uncontrolled hypertension (systolic blood pressure \>180mmHg or diastolic blood pressure \>110mmHg) or hypotension (systolic blood pressure\<100mmHg) measured during baseline visit anthropometric assessments.
21. Severe abnormalities on standard clinical labs measured prior to the baseline visit, without clinician clearance, including hemoglobin A1c (\>10%) and urinary albumin: creatinine ratio (\>300 mg/g).
22. Other medical, psychiatric, or behavioral factors or participation in other research studies that, based on the judgment of the multiple principal investigators, may interfere with study participation, assessments, or the ability to follow either the exercise intervention or the health education control.
23. Use of a permanent or temporary urinary catheter.

Primary outcomes:
measure: Feasibility: proportion randomized
timeFrame: 18-24 months
measure: Acceptability: proportion satisfied with exercise intervention
timeFrame: 3 months
measure: Fidelity: proportion completing at least 70% of exercise sessions
timeFrame: 3 months
measure: Safety: number of adverse events
timeFrame: 3 months
measure: Change in International Prostate Symptom Score
timeFrame: 3 months
measure: Change in maximum urinary flow rate
timeFrame: 3 months
Secondary outcomes:
measure: Acceptability: proportion who would recommend exercise intervention
timeFrame: 3 months
measure: Fidelity: number of exercise sessions completed for aerobic, resistance, and balance/flexibility exercise
timeFrame: 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Health - Mission Bay Campus
state: California
Study officials:
affiliation: University of California, San Francisco
name: Scott R. Bauer, MD, ScM
role: PRINCIPAL_INVESTIGATOR
References: