PRescription Exercise for Older Men With Urinary Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age60+
SponsorUniversity of California, San Francisco
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Exercise
- Calls and Newsletter
Treatment groups
68 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of California, San Francisco
Lead sponsor
University of California, Berkeley
Collaborator
University of California, San Diego
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov