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New treatment option for Lower Urinary Tract Symptoms
Official title PRescription Exercise for Older Men With Urinary Disease
ClinicalTrials.gov ID: NCT06225479
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older, men only
You may be able to join if
- 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...
- Physically inactive as defined in the Molecular Transducers of Physical Activity Consortium (MoTrPAC): no more than 1 day per week, lasting no more...
You likely can't join if
- 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'...
- Initiation, dose escalation, or weaning of other pharmacologic agents or dietary supplements that might affect LUTS (e.g., saw palmetto...
- History of BPH procedure or surgery.
- History of overactive bladder procedure (e.g., intravesical Botox, sacral neuromodulation, posterior tibial nerve stimulation).
- History of prostate cancer (treated with surgery or radiation), bladder cancer, other lower urinary tract cancer, pelvic radiation, or active...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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.
- Able to speak and complete questionnaires in English.
- Have an iOS or Android smartphone capable of installing the Polar Beat app.
What rules you out
- 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...
- 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...
- History of BPH procedure or surgery.
- History of overactive bladder procedure (e.g., intravesical Botox, sacral neuromodulation, posterior tibial nerve stimulation).
- History of prostate cancer (treated with surgery or radiation), bladder cancer, other lower urinary tract cancer, pelvic radiation, or active non-urologic cancer treatments.
- History of urethral strictures.
- History of neurogenic bladder or neurologic conditions causing lower urinary tract dysfunction (e.g., Parkinson's disease, multiple sclerosis, other progressive neurological disease).
- History of recurrent bladder or prostate infections (3 or more infections in the previous 12 months before screening).
- 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)...
- 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...
- Bladder or prostate infection \<1 months before screening. If infection occurred between 1 to \<3 months before screening, can participate with clinician clearance.
- Major surgery \<3 months before screening or scheduled in the subsequent 7 months.
- Terminal illness diagnosis with estimated life expectancy \<12 months.
- Plan to leave the study area for \>28 consecutive days during the subsequent 7 months.
- Participation in formal behavioral LUTS interventions (e.g., pelvic floor physiotherapy) \<1 month before screening.
- 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...
- Maximum urinary flow rate \<=4 ml/sec OR volume voided during free flow \<120ml during screening or the baseline visit.
- Post-void residual \>=450ml measured by ultrasound during screening or the baseline visit.
- Uncontrolled hypertension (systolic blood pressure \>180mmHg or diastolic blood pressure \>110mmHg) or hypotension (systolic blood pressure\<100mmHg) measured during baseline visit anthropometric assessments.
- 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).
- 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...
- Use of a permanent or temporary urinary catheter.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.