Exercise for Enlarged Prostate

(PROUD Trial)

Recruiting at 1 trial location

Overseen By Stacey Kenfield, ScD

Age: 18+

Sex: Male

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

68 Participants Needed

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. ^{1 2 3 4 5}

Is exercise safe for people with prostate conditions?

Exercise is generally safe for people with prostate conditions and can improve various health aspects, such as muscle strength and cardiovascular fitness, without significant adverse effects. ^{6 7 8 9 10}

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. ^{4 5 10 11 12}

Research Team

Scott R. Bauer, MD, ScM

Principal Investigator

University of California, San Francisco

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.

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

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

Trial Overview The 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

Group I: Exercise Arm Experimental Treatment 1 Intervention

Participants in this study arm will receive an individualized 12-week exercise intervention plus a remote health education program.

Group II: Control Arm Active Control 1 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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

University of California, Berkeley

Collaborator

Trials

193

Recruited

716,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Engaging in a supervised exercise program before prostate surgery (prehabilitation) significantly improved muscle strength and physical function in men with prostate cancer, helping to mitigate declines after surgery.

While post-surgery rehabilitation also improved strength and function, there were no significant differences in urinary incontinence, hospital stay, or patient-reported outcomes between prehabilitation and rehabilitation groups, suggesting that pre-surgery exercise is particularly beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitative versus rehabilitative exercise in prostate cancer patients undergoing prostatectomy. Singh, F., Newton, RU., Taaffe, DR., et al.[2023]

Physical activity after a prostate cancer diagnosis is linked to slower disease progression and improved survival rates, as shown by various observational studies and clinical trials.

The review provides evidence-based recommendations for healthcare providers on how to effectively incorporate specific types of physical activity into treatment plans for prostate cancer patients, addressing the need for guidance on exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Should We Tell Patients About Physical Activity After a Prostate Cancer Diagnosis? Ramalingam, S., Pollak, KI., Zullig, LL., et al.[2020]

A 10-week structured exercise program for 41 men with prostate cancer received overwhelmingly positive feedback, highlighting benefits such as increased exercise confidence, motivation, and social support.

While most participants preferred structured exercise classes, individual preferences varied, indicating that future interventions should be tailored to accommodate these differences and include ongoing patient feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Fox, L., Cahill, F., Burgess, C., et al.[2022]

A systematic review of 25 randomized controlled trials found that physical exercise can significantly improve quality of life, fitness, and reduce fatigue in prostate cancer patients during and after medical treatment.

Supervised exercise programs were shown to be more effective than non-supervised ones, highlighting the importance of structured support in exercise interventions for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical exercise interventions in prostate cancer patients--a systematic review of randomized controlled trials. Baumann, FT., Zopf, EM., Bloch, W.[2022]

In a study of 71 men with low-risk prostate cancer, those who engaged in at least 3 hours of vigorous physical activity per week showed up-regulation of important pathways related to cell cycling and DNA repair, suggesting a potential protective effect against cancer progression.

The research indicates that vigorous activity may influence gene expression in normal prostate tissue, highlighting biological mechanisms that could help reduce the risk of prostate cancer progression, although further studies are needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and prostate gene expression in men with low-risk prostate cancer. Magbanua, MJ., Richman, EL., Sosa, EV., et al.[2021]

A review of 14 studies indicates a strong inverse relationship between exercise and the development of benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS), suggesting that a healthy lifestyle can significantly impact prostate health.

Proposed mechanisms for this relationship include reduced sympathetic nervous system activity, prevention of metabolic syndrome, and decreased oxidative damage to the prostate, highlighting the importance of exercise in maintaining prostate health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of exercise and the risk of benign prostatic hyperplasia. Sea, J., Poon, KS., McVary, KT.[2010]

Men aged 45 and over with sedentary or light occupational work had a higher risk of incidental prostate cancer, with an odds ratio of 1.9, indicating a significant association between low physical activity at work and prostate cancer risk.

Conversely, higher levels of occupational physical activity were linked to a reduced risk of prostate cancer, with odds ratios decreasing from 1.0 for sedentary jobs to 0.2 for high/very high activity levels, suggesting that being more active at work may help lower the risk of developing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifetime occupational physical activity and incidental prostate cancer (Canada). Bairati, I., Larouche, R., Meyer, F., et al.[2019]

A systematic review of 21 trials involving 1748 prostate cancer patients found that resistance exercise significantly improved body composition, functional capacity, and muscle strength, with a notable reduction in fat mass and an increase in lean mass.

The study suggests that lower volume resistance training at moderate to high intensity is just as effective as higher volume training, which may help make exercise more accessible and encourage adherence among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance Exercise Dosage in Men with Prostate Cancer: Systematic Review, Meta-analysis, and Meta-regression. Lopez, P., Taaffe, DR., Newton, RU., et al.[2023]

A supervised exercise program combining endurance and resistance training significantly improved various health markers in 27 prostate cancer patients undergoing androgen-deprivation therapy, including muscular endurance and cardiorespiratory fitness.

Participants also experienced improvements in quality of life, as evidenced by better performance in the six-minute walk test and reduced depression levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. Caty, G., Salazar Gajardo, S., Butoescu, V., et al.[2019]

Men who underwent pelvic muscle exercise (PME) with biofeedback after radical prostatectomy regained urinary continence faster (mean of 51 days) compared to those who did not receive PME instruction (56 days).

While the PME/biofeedback group showed improvements in urinary incontinence metrics such as episodes and pad usage, these changes were not statistically significant, indicating that further research is needed to confirm the effectiveness of PME as a treatment for urinary incontinence post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic muscle exercise/biofeedback for urinary incontinence after prostatectomy: an education program. Mathewson-Chapman, M.[2015]

Pelvic floor muscle exercises significantly improved urinary symptoms, such as reduced frequency of urination and terminal dribbling, in patients after transurethral prostatectomy, with notable differences observed as early as 4 weeks post-exercise.

Patients who engaged in pelvic floor muscle exercises reported higher satisfaction with life compared to those who did not, indicating that these exercises not only help with physical symptoms but also enhance psychological and social well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The early effect of pelvic floor muscle exercise after transurethral prostatectomy. Chang, PL., Tsai, LH., Huang, ST., et al.[2006]

A systematic analysis of 150 YouTube videos on pelvic floor muscle training after prostate cancer surgery revealed that the overall quality of these videos is high, with average scores of 3.35 on the DISCERN Scale and 3.38 on the Global Quality Score.

The videos had a significant reach, averaging over 124,000 views, indicating that they are widely accessed by patients seeking information on postoperative exercises, highlighting the need for health professionals to ensure the accuracy and reliability of online health resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality Analysis of YouTube Videos Presenting Pelvic Floor Exercises after Prostatectomy Surgery. Rodriguez-Rodriguez, AM., Blanco-Diaz, M., Lopez-Diaz, P., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Prehabilitative versus rehabilitative exercise in prostate cancer patients undergoing prostatectomy. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

What Should We Tell Patients About Physical Activity After a Prostate Cancer Diagnosis? [2020]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. Germany pubmed.ncbi.nlm.nih.gov

Clinical exercise interventions in prostate cancer patients--a systematic review of randomized controlled trials. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Physical activity and prostate gene expression in men with low-risk prostate cancer. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Review of exercise and the risk of benign prostatic hyperplasia. [2010]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Lifetime occupational physical activity and incidental prostate cancer (Canada). [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Resistance Exercise Dosage in Men with Prostate Cancer: Systematic Review, Meta-analysis, and Meta-regression. [2023]

9. Belgium pubmed.ncbi.nlm.nih.gov

[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Pelvic muscle exercise/biofeedback for urinary incontinence after prostatectomy: an education program. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

The early effect of pelvic floor muscle exercise after transurethral prostatectomy. [2006]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Quality Analysis of YouTube Videos Presenting Pelvic Floor Exercises after Prostatectomy Surgery. [2021]