PRescription Exercise for Older Men With Urinary Disease

Benign Prostatic Hyperplasia Clinical Trial

— PROUD  

Official title:

PRescription Exercise for Older Men With Urinary Disease (PROUD) Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06225479
• Other study ID #: 1R01DK135804-01
• Secondary ID: R01DK135804
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: February 2024
• Source: University of California, San Francisco
• Contact: Scott R. Bauer, MD, ScM
• Phone: 415-221-4810
• Email: Scott.Bauer[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Behavioral:
• Exercise
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).

Other:
• Calls and Newsletter
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.

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center	San Francisco	California
United States	UCSF Health - Mission Bay Campus	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, Berkeley, University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: proportion randomized	Proportion of participants randomized of those screened (completed screening call)	18-24 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Acceptability: proportion who would recommend exercise intervention	Proportion of intervention arm participants who would recommend the exercise intervention to others at 12 weeks, assessed via digital survey prior to the week 12 visit	3 months
Secondary	Fidelity: number of exercise sessions completed for aerobic, resistance, and balance/flexibility exercise	Number of exercise sessions completed over 12 weeks, recorded by the exercise coach based on participant exercise session records. The coach will also report the number of aerobic and resistance exercise sessions completed as prescribed or with greater duration or intensity (e.g., higher heart rate for aerobic sessions or greater sets, reps, and/or weight for resistance sessions) over 12 weeks, based on coaching calls.	3 months