Prescription exercise for Older men with Urinary Disease (PROUD) pilot study

PROJECT SUMMARY/ABSTRACT
One in 3 American men will develop bothersome lower urinary tract symptoms in their lifetime, and the majority
will be attributed to benign prostatic hyperplasia (LUTS/BPH). Older men with LUTS/BPH have increased risk
of developing new mobility limitations, falls, fractures, disability, and death. Unfortunately, current LUTS/BPH
medications targeting prostate-centric mechanisms likely further increase risk of some of these adverse clinical
outcomes, have modest efficacy, and poor adherence. Frailty-related mechanisms are novel LUTS/BPH
intervention targets that may be preventable or modifiable via an exercise intervention. Our team has
previously created an individualized, remotely-monitored, and home-based exercise program based on well-
known behavioral change principles and prioritization of scalable interventions requiring minimal equipment for
older men with prostate cancer. However, a pilot study is required to determine the feasibility and optimal trial
design for testing this exercise intervention in physically inactive older men with LUTS/BPH.
We therefore propose a single-center pilot randomized controlled trial among 68 physically inactive older men
with LUTS/BPH of a 12-week multicomponent exercise intervention versus health education control. The
exercise intervention includes personalized written and pictorial instructions on aerobic and resistance
exercises, supported by weekly one-on-one coaching by phone or video call, along with heart rate monitor
biofeedback and the provision of limited equipment. The following aims must be addressed prior to conducting
an adequately powered efficacy trial: Aim 1: Evaluate the feasibility, acceptability, fidelity, and safety of a
remote exercise intervention and health education control among physically inactive older men with LUTS/BPH
(N=68 total) 34/arm); Aim 2: Assess the magnitude, variability, and durability of changes in LUTS, urologic and
physical function, and actigraphy measures after a 12-week exercise intervention or health education control;
and Aim 3: Assess the feasibility of detecting exercise-induced change in novel frailty-related mechanistic
measures (total muscle mass, mitochondrial function, urine α1-microglobulin). This project is innovative
because it leverages a remote exercise intervention with pleotropic and systemic effects across multiple organ
systems, in contrast to existing prostate-centric pharmacological and surgical therapies with side effects that
are critical to avoid in older men. Our project will accomplish the extensive feasibility work that is required for
both a future efficacy trial and the frailty-related mechanistic biomarker measurements.
This pilot study is an important step towards an extended, fully-powered efficacy trial with a secondary focus
on frailty-related mechanisms of an exercise intervention for treating LUTS/BPH. This future efficacy trial has
the potential to transform both the clinical care for physically inactive older men with LUTS/BPH while
simultaneously increasing our understanding of how exercise affects frailty-related LUTS/BPH mechanisms.

Grant Number: 5R01DK135804-03
NIH Institute/Center: NIH
Principal Investigator: Scott Bauer