Exercise for Enlarged Prostate
(PROUD Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Francisco
Must be taking: BPH medications
Must not be taking: Overactive bladder medications
Disqualifiers: Cancer, Neurologic conditions, Heart disease, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial requires that participants do not start, stop, or change their BPH medications or other medications affecting urinary symptoms for the entire study period of 7 months, unless necessary by their clinician.
What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for an enlarged prostate?
Research shows that physical activity in men with prostate cancer can lead to positive effects, such as reducing disease progression and improving quality of life. Although these studies focus on prostate cancer, they suggest that exercise may also benefit men with an enlarged prostate by improving overall health and reducing related symptoms.12345
Is exercise safe for people with prostate conditions?
How does exercise differ from other treatments for an enlarged prostate?
Exercise, as a treatment for an enlarged prostate, is unique because it focuses on improving overall physical health and potentially reducing symptoms through physical activity, rather than using medication or surgery. Unlike drugs or surgical options, exercise may also enhance quality of life by reducing fatigue and improving mood, which are common issues in prostate conditions.45101112
Eligibility Criteria
Men aged 60+ with moderate-to-severe urinary symptoms due to enlarged prostate, not very active physically, can walk 400m unaided (cane ok), and have a smartphone. They shouldn't be on certain bladder medications or have had recent changes in prostate meds, nor should they have a history of specific urologic surgeries or cancers.Inclusion Criteria
I am 60 years old or older.
I was assigned male at birth.
I have had moderate to severe urinary symptoms in the past month.
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Exclusion Criteria
I have had narrowings in my urethra before.
I haven't had major surgery in the last 3 months and don't plan any in the next 7 months.
Post-void residual >=450ml measured by ultrasound during screening or the baseline visit
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a 12-week remote exercise intervention or health education control
12 weeks
Weekly remote monitoring and bi-weekly phone calls
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Exercise (Behavioral Intervention)
Trial OverviewThe study is testing if a remote exercise program helps older men with urinary issues from an enlarged prostate better than just receiving health education. Participants will either do the exercises or get calls and newsletters for comparison.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise ArmExperimental Treatment1 Intervention
Participants in this study arm will receive an individualized 12-week exercise intervention plus a remote health education program.
Group II: Control ArmActive Control1 Intervention
Participants in this study arm will receive a remote health education program which consists of twice-monthly "Successful Aging" newsletters and phone calls to reinforce and discuss topics in each newsletter.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
San Francisco VA Medical CenterSan Francisco, CA
UCSF Health - Mission Bay CampusSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
University of California, BerkeleyCollaborator
University of California, San DiegoCollaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Prehabilitative versus rehabilitative exercise in prostate cancer patients undergoing prostatectomy. [2023]The study compared the efficacy of commencing supervised exercise in men with prostate cancer before and after prostatectomy on objective and patient-reported outcomes, hospital length of stay, and urinary incontinence.
What Should We Tell Patients About Physical Activity After a Prostate Cancer Diagnosis? [2020]A number of observational studies and clinical trials have shown that physical activity after a diagnosis of prostate cancer is associated with a decrease in disease progression and an increase in survival, and that specific exercises reduce morbidity from prostate cancer treatments. However, providers need more guidance on what types of physical activity to recommend to patients across different disease states and treatments in prostate cancer, and when and how to initiate the discussion. In addition to evaluating important studies showing benefits of physical activity in patients with prostate cancer, this review suggests some evidence-based methods for incorporating physical activity interventions into clinical practice.
Real World Evidence: A Quantitative and Qualitative Glance at Participant Feedback from a Free-Response Survey Investigating Experiences of a Structured Exercise Intervention for Men with Prostate Cancer. [2022]To explore patient experiences of a structured exercise intervention for men with prostate cancer (PCa).
Clinical exercise interventions in prostate cancer patients--a systematic review of randomized controlled trials. [2022]Urinary incontinence, erectile dysfunction, fatigue as well as fears and depression rank among the most common complaints in patients with prostate cancer, resulting in a reduced participation in daily life and social isolation. Consequently, the quality of life of prostate cancer patients is strongly affected in a negative way. Numerous studies focusing on physical exercise interventions in prostate cancers patients demonstrate positive physiological and psychological effects. Our objective was to evaluate the evidence of randomized controlled studies which examined exercise during medical treatment and in the aftercare of a prostate cancer disease.
Physical activity and prostate gene expression in men with low-risk prostate cancer. [2021]Vigorous physical activity after diagnosis of localized prostate cancer may reduce the risk of disease progression and prostate cancer-specific mortality. The molecular mechanisms by which physical activity may exert protective effects in the prostate remain unknown.
Review of exercise and the risk of benign prostatic hyperplasia. [2010]It has been long appreciated that a healthy lifestyle plays a critical role in cardiovascular health. It is now apparent that the same is true in the development of benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS). Since 1995, 14 studies have been identified that investigate the clinical relationship between exercise and BPH/LUTS. No randomized controlled trials have been performed, but useful prospective cohort data originating from recent publications on the medical treatment of BPH and prevention of prostate cancer are available. Most of the literature supports a clinically significant, independent, and strong inverse relationship between exercise and the development of BPH/LUTS. Several mechanisms for this relationship have been proposed, including decreased sympathetic tone, avoidance of metabolic syndrome, and reduced oxidative damage to the prostate.
Lifetime occupational physical activity and incidental prostate cancer (Canada). [2019]The objective of this study was to assess the risk of incidental prostate cancer associated with occupational physical activity in a population of patients treated for benign prostatic hyperplasia (BPH) by transurethral resection of the prostate (TURP).
Resistance Exercise Dosage in Men with Prostate Cancer: Systematic Review, Meta-analysis, and Meta-regression. [2023]Resistance exercise improves an array of treatment-related adverse effects in men with prostate cancer; however, the minimal dosage required is unknown. We systematically reviewed the resistance training effects in prostate cancer patients to determine the minimal dosage regarding the exercise components (type, duration, volume, and intensity) on body composition, physical function, muscle strength, cardiorespiratory fitness, body mass index, and prostate-specific antigen.
[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. [2019]Prostate cancer is the most common cancer in men in Belgium. Its treatment is mainly based on androgen-deprivation therapy, which is accompanied by some adverse effects (e.g., sarcopenic obesity, osteoporosis). We evaluated the benefits of a supervised exercise program combining endurance and resistance training on these adverse events, patient participation, and quality of life in twenty-seven prostate cancer patients treated with androgen-deprivation therapy. We observed a significant improvement in systolic blood pressure, quadriceps and hamstrings muscular endurance, cardiorespiratory endurance, distance in the six-minute walk test and depression.
Pelvic muscle exercise/biofeedback for urinary incontinence after prostatectomy: an education program. [2015]This study tested the effectiveness of pelvic muscle exercise (PME) with biofeedback in reducing the length of time urinary incontinence (UI) was experienced following a radical prostatectomy for localized prostate cancer.
The early effect of pelvic floor muscle exercise after transurethral prostatectomy. [2006]We evaluate the early effect of pelvic floor muscle exercise on the frequency of urination, terminal dribbling, urinary incontinence and satisfaction with life in patients after transurethral prostatectomy.
Quality Analysis of YouTube Videos Presenting Pelvic Floor Exercises after Prostatectomy Surgery. [2021]Prostate cancer (PC) is a major cause of disease and mortality among men. Surgical treatment involving the removal of the prostate may result in temporary or permanent erectile dysfunction (ED) and urinary incontinence (UI), with considerable impact on quality of life. Pelvic floor muscle training (PFMT) is one of the recommended techniques for the prevention, treatment, and rehabilitation of postoperative complications. The aim of this observational study was to assess the quality of YouTube videos-accessible to any patient-related to exercises after prostatectomy surgery.