Summary

Eligibility
for males ages 60 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Scott R. Bauer, MD, ScM

Description

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.

Official Title

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

Details

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).

Keywords

Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia, physical fitness, endurance training, resistance training, prostatism, male urogenital diseases, urinary bladder outlet obstruction, skeletal muscle, mitochondria, Prostatic Hyperplasia, Hyperplasia, Exercise, Calls and Newsletter

Eligibility

You can join if…

Open to males ages 60 years and up

  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.

You CAN'T join if...

  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.

Locations

  • San Francisco VA Medical Center accepting new patients
    San Francisco California 94121 United States
  • UCSF Health - Mission Bay Campus accepting new patients
    San Francisco California 94158 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06225479
Study Type
Interventional
Participants
Expecting 68 study participants
Last Updated