PRescription Exercise for Older Men With Urinary Disease

Last updated: March 13, 2025
Sponsor: University of California, San Francisco
Overall Status: Active - Recruiting

Phase

N/A

Condition

Enuresis

Prostate Disorders

Interstitial Cystitis

Treatment

Calls and Newsletter

Exercise

Clinical Study ID

NCT06225479
1R01DK135804-01
R01DK135804
  • Ages > 60
  • Male

Study 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.

Eligibility Criteria

Inclusion

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 ProstateSymptom Score [IPSS] >=12).

  4. A clinical diagnosis of LUTS/BPH as demonstrated by a current or prior BPHmedication prescription (alpha-blocker, 5alpha-reductase inhibitor, dailyphosphodiesterase type 5 inhibitor) OR untreated LUTS/BPH and a maximum urinary flowrate <=12 ml/sec.

  5. Physically inactive as defined in the Molecular Transducers of Physical ActivityConsortium (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 increasedheart rate (HR), rapid breathing, and/or sweating] or resistance exercise [resultingin muscular fatigue] in the past year). Leisure walkers are eligible unless theymeet the HR, breathing, and sweating criteria.

  6. Able to walk 400m without sitting, leaning, or the help of another person (observedduring 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

Exclusion Criteria:

  1. Prescribed overactive bladder medications (e.g., anti-muscarinics, beta-3-adrenergicagonists) <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 tonot start, stop, or change their BPH medications for the subsequent 7 months (theentire study period).

  3. Initiation, dose escalation, or weaning of other pharmacologic agents or dietarysupplements that might affect LUTS (e.g., saw palmetto, testosterone, diuretics,glucose-lowering agents) <1 month before screening. Participants' must also bewilling 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, sacralneuromodulation, 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 cancertreatments.

  7. History of urethral strictures.

  8. History of neurogenic bladder or neurologic conditions causing lower urinary tractdysfunction (e.g., Parkinson's disease, multiple sclerosis, other progressiveneurological disease).

  9. History of recurrent bladder or prostate infections (3 or more infections in theprevious 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 currentNew York Heart Association (NYHA) Class III or IV), valvular heart disease, diabeticcoma, or the presence of a pacemaker or implantable cardiac defibrillator withoutclinician clearance.

  11. Heart attack or myocardial infarction, heart surgery, cardiac catheterization,stroke, transient ischemic attack, brain hemorrhage, bleeding brain aneurysm, bloodclot in leg or lungs, symptomatic hypoglycemia or hyperglycemia, hip fracture, ornon-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 occurredbetween 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 7months.

  16. Participation in formal behavioral LUTS interventions (e.g., pelvic floorphysiotherapy) <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, poorlycontrolled diabetes, peripheral vascular disease, or bladder or prostate infectionwithout clinician clearance.

  18. Maximum urinary flow rate <=4 ml/sec OR volume voided during free flow <120ml duringscreening or the baseline visit.

  19. Post-void residual >=450ml measured by ultrasound during screening or the baselinevisit.

  20. Uncontrolled hypertension (systolic blood pressure >180mmHg or diastolic bloodpressure >110mmHg) or hypotension (systolic blood pressure<100mmHg) measured duringbaseline 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 researchstudies that, based on the judgment of the multiple principal investigators, mayinterfere with study participation, assessments, or the ability to follow either theexercise intervention or the health education control.

  23. Use of a permanent or temporary urinary catheter.

Study Design

Total Participants: 68
Treatment Group(s): 2
Primary Treatment: Calls and Newsletter
Phase:
Study Start date:
January 03, 2024
Estimated Completion Date:
April 01, 2026

Study 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).

Connect with a study center

  • San Francisco VA Medical Center

    San Francisco, California 94121
    United States

    Active - Recruiting

  • UCSF Health - Mission Bay Campus

    San Francisco, California 94158
    United States

    Active - Recruiting

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