PRescription Exercise for Older Men With Urinary Disease

NCT06225479 | Recruiting DMC

• 2 other identifiers: 1R01DK135804-01R01DK135804
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (6)

• Feasibility: proportion randomized

  Proportion of participants randomized of those screened (completed screening call)

  18-24 months

• Acceptability: proportion satisfied with exercise intervention

  Proportion of participants who report being satisfied or very satisfied with the exercise intervention at 12 weeks, assessed via digital survey prior to the week 12 visit

  3 months

• Fidelity: proportion completing at least 70% of exercise sessions

  Proportion of intervention arm non-drop-outs completing at least 70% of exercise sessions over 12 weeks

  3 months

• Safety: number of adverse events

  Number of adverse events, serious adverse events, and unexpected problems (as defined in the Data and Safety Monitoring Plan) by study. Adverse event severity will be defined by the Common Terminology Criteria for Adverse Events (CTCAE) and whether "attributable" to the exercise intervention.

  3 months

• Change in International Prostate Symptom Score

  Change in International Prostate Symptom Score (IPSS) from weeks 0 to 12, collected via digital surveys prior to week 0 (baseline) and 12-week visits. Range: 0 (minimum - better) to 35 (maximum - worse)

  3 months

• Change in maximum urinary flow rate

  Change in maximum urinary flow rate (Q max) from weeks 0 to 12, measured by trained clinical urology staff using a uroflowmeter in mL per second

  3 months

Secondary Outcomes (2)

• Acceptability: proportion who would recommend exercise intervention

  3 months

• Fidelity: number of exercise sessions completed for aerobic, resistance, and balance/flexibility exercise

  3 months

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Participants in this study arm will receive a remote health education program which consists of twice-monthly "Successful Aging" newsletters and phone calls to reinforce and discuss topics in each newsletter.

Other: Calls and Newsletter

Exercise Arm

EXPERIMENTAL

Participants in this study arm will receive an individualized 12-week exercise intervention plus a remote health education program.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

An individualized 12-week exercise intervention that will follow American College of Sports Medicine guidelines to ensure a gradual safe increase in frequency and intensity. The exercise goals for participants in the intervention arm are to increase minutes/week of aerobic exercise, build strength and muscle mass, and improve flexibility, core strength, and balance progressively over the course of 12 weeks. The participants are prescribed 3 sessions of aerobic exercise lasting 45-75 minutes each, including warm up and cool down; 2 resistance training sessions per week, and at least 3 flexibility and balance sessions per week. Intervention arm receives the following: Control arm "Successful Aging" newsletter plus additional educational materials related to exercise, heart rate monitor and resistance bands, and two 90-minute sessions and ten 30-minute phone sessions over 12 weeks with an exercise coach (the first two sessions include a resistance training session).

Exercise Arm

Calls and Newsletter OTHER

A 12-week remote health education program developed by the study team to provide a control for the exercise intervention. Participants in this arm will receive a summary of the American College of Sports Medicine guidelines (self-directed and time-based), a twice-monthly "Successful Aging" newsletter with suggestions for health diet, stress reduction, and social engagement, and twice-monthly phone calls to reinforce and discuss topics in the newsletter and to review adverse events and change in medications.

Control Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 years or older.
• Male sex at birth.
• Moderate-to-severe LUTS over the past month (defined as International Prostate Symptom Score \[IPSS\] \>=12).
• 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.
• 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.
• 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.
• Able to speak and complete questionnaires in English.
• Have an iOS or Android smartphone capable of installing the Polar Beat app.

You may not qualify if:

• Prescribed overactive bladder medications (e.g., anti-muscarinics, beta-3-adrenergic agonists) \<3 months before screening.
• 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).
• 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.
• History of BPH procedure or surgery.
• History of overactive bladder procedure (e.g., intravesical Botox, sacral neuromodulation, posterior tibial nerve stimulation).
• History of prostate cancer (treated with surgery or radiation), bladder cancer, other lower urinary tract cancer, pelvic radiation, or active non-urologic cancer treatments.
• History of urethral strictures.
• History of neurogenic bladder or neurologic conditions causing lower urinary tract dysfunction (e.g., Parkinson's disease, multiple sclerosis, other progressive neurological disease).
• History of recurrent bladder or prostate infections (3 or more infections in the previous 12 months before screening).
• 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.
• 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.
• Bladder or prostate infection \<1 months before screening. If infection occurred between 1 to \<3 months before screening, can participate with clinician clearance.
• Major surgery \<3 months before screening or scheduled in the subsequent 7 months.
• Terminal illness diagnosis with estimated life expectancy \<12 months.
• Plan to leave the study area for \>28 consecutive days during the subsequent 7 months.

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Berkeley: collaborator
• University of California, San Diego: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

RECRUITING

UCSF Health - Mission Bay Campus

San Francisco, California, 94158, United States

RECRUITING

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia; Prostatism; Male Urogenital Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Scott R. Bauer, MD, ScM

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott R. Bauer, MD, ScM

CONTACT

415-221-4810; Scott.Bauer@ucsf.edu

Stacey Kenfield, ScD

CONTACT

415.476.5392; Stacey.Kenfield@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This will be a 2-arm, partially-blinded, attention-controlled RCT. The randomization scheme will be computer-generated by the study statistician without participant contact. Participants will be randomized 1:1 in randomly permuted block sizes (2 or 4) to the exercise intervention or health education control arm stratified by recruitment site and any BPH medication use (yes/no). The randomization scheme is uploaded to University of California San Francisco (UCSF) REDCap and the study coordinator will randomize participants in UCSF REDCap. Assessors (for urinary and physical function testing), data analysts, and investigators will remain blinded to participants' randomization arm. Primary outcomes will be collected using self-administered questionnaires without risk of unblinding. Intervention status and any variables related to intervention status will be recorded and stored in a separate database by unblinded Clinical Research Coordinator (CRC).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 26, 2024
• Study Start: January 3, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: After study completion
• Access Criteria: Investigators will have to execute a data use agreement before documents with data from the study are sent.

Locations

US (2)