Pelvic Floor Physical Therapy for Prostate Cancer

Overseen By Kim Smoot

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Previous prostate surgery, Radiation, Incontinence

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if pelvic floor muscle training with a physical therapist can improve quality of life after prostate cancer surgery. Participants will either receive instructions on Kegel exercises or attend additional sessions with a physical therapist. The study seeks men planning to undergo robot-assisted prostate surgery, who have not had prior prostate surgeries, and do not currently experience urinary leakage. As an unphased trial, it offers participants the chance to contribute to important research that may enhance recovery and quality of life after surgery.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that pelvic floor muscle physical therapy is safe for prostate cancer patients?

Research shows that pelvic floor muscle exercises are safe for prostate cancer patients, even those with advanced disease. Studies have found these exercises to be gentle and non-harmful. Patients generally tolerate them well. This therapy helps manage urinary incontinence (loss of bladder control) after surgery. Overall, evidence suggests that pelvic floor muscle training is a safe option for those recovering from prostate surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of pelvic floor physical therapy for prostate cancer patients. Unlike the standard approach, which typically involves patients being given basic instructions on Kegel exercises, this trial incorporates personalized training sessions with a professional therapist. This hands-on approach aims to enhance recovery and improve pelvic floor strength more effectively than existing methods, potentially leading to better overall outcomes for patients undergoing prostate cancer treatment.

What evidence suggests that pelvic floor muscle physical therapy might be an effective treatment for improving quality of life after prostate cancer surgery?

Research has shown that pelvic floor muscle therapy, which participants in this trial may receive, can greatly improve bladder control in patients after prostate surgery. One study found that 19% of patients who performed pelvic floor exercises had no leakage after just one month, and 94.6% achieved this goal after six months. In contrast, only 8% of those who did not undergo the therapy had no leakage after one month, and 65% after six months. Another study found that combining regular exercises with pelvic floor training improved outcomes for those experiencing stress urinary incontinence, which is leakage when coughing or sneezing. Overall, these findings suggest that working with a physical therapist on pelvic floor exercises can significantly help men regain control after prostate surgery. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for men who are planning to have robot-assisted surgery to remove the prostate due to cancer. They must be able to understand and agree to the study's process, and willing to fill out a health questionnaire. Men who've had radiation treatments, previous prostate surgeries, or any urinary leakage requiring pads in the last 6 months cannot participate.

Inclusion Criteria

Patients willing and able to complete the EPIC questionnaire in its entirety

Ability to provide informed consent

I am scheduled for a robotic surgery to remove my prostate.

Exclusion Criteria

I have had surgery on my prostate before.

I am undergoing or have undergone radiation treatment.

I have used pads for urinary leakage in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Training

Participants receive pelvic floor muscle training through a course of three one-hour sessions with a trained pelvic floor physical therapist

1-6 weeks

3 visits (in-person)

Postoperative Training

Participants continue pelvic floor muscle training with sessions at 7-10 days and 4-8 weeks postoperative

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for recovery of continence and quality of life improvements after surgery

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control Group
• Pelvic Floor Muscle Physical Therapy

Trial Overview The study is testing if special exercises for pelvic floor muscles taught by a physical therapist can improve life quality after prostate removal surgery. Participants will either receive this therapy or be placed in a control group without it.

How Is the Trial Designed?

Group I: Control Group Active Control 1 Intervention

Written and verbal information on performing Kegel exercises (exercises that aim to strengthen pelvic floor muscles) will be provided at the pre-op clinic visit.

Group II: Physical Therapy Treatment Group Active Control 1 Intervention

Written and verbal information on performing Kegel exercises (exercises that aim to strengthen pelvic floor muscles) will be provided at the pre-op clinic visit. The treatment group will receive pelvic floor muscle training through a course of three one-hour sessions with a trained pelvic floor physical therapist in addition to the current standard information from their surgeon. The physical therapy sessions will be conducted at 1-6 weeks preoperative, 7-10 days postoperative, and 4-8 weeks postoperative .

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Indiana University Health

Collaborator

Trials

35

Recruited

18,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12403351/

Pelvic floor rehabilitation before radical prostatectomy Pelvic floor prehabilitation may help improve urinary continence following radical prostatectomy; however, there is a paucity of studies ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/13685538.2025.2530469

Study of the effectiveness of different pelvic floor muscle ... Conclusion. While all PFMT modalities led to significant improvements in SUI among PCa patients after RP, the combination of standard PFMT with pelvic floor ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772973725008860

Feasibility and Functional Outcomes of Community-Based ... Community-based pelvic floor rehabilitation appears feasible and beneficial for functional recovery following radical prostatectomy. Future controlled studies ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6858802/

The Impact Of Pelvic Floor Muscle Training On Urinary ... In the EG, 19% of patients achieved continence after 1 month, and 94.6% after 6 months. In the CG, 8% of patients achieved continence after 1 month, and 65% ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04027270

Study Details | Pelvic Health and Physical Therapy to ... Pelvic Health and Physical Therapy to Improve Lives of Prostate Cancer ... Pelvic muscle rehabilitation: a standardized protocol for pelvic floor dysfunction.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9459549/

A narrative review of pelvic floor muscle training in the ... In their Prostate Cancer Outcomes Study, Stanford and colleagues detailed that 66.4% of patients reported incontinence at 6 months following prostatectomy, with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10523151/

Barriers and facilitators of the implementation ... It has been shown that exercise of the pelvic floor muscles is safe for older PCa patients with signs of advanced disease, such as bone metastases. PFMT is a ...

8. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1191508/full

Barriers and facilitators of the implementation ... It has been shown that exercise of the pelvic floor muscles is safe for older PCa patients with signs of advanced disease, such as bone metastases. PFMT is a ...

9. e-century.us e-century.us/files/ajceu/11/4/ajceu0149176.pdf

Impact of exercise on continence in prostate cancer ... Conclusion: Pelvic floor muscle training, with or without adjunct therapies, results in improved continence outcomes post RALP. Supervised ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1166708722001221

A systematic review of supervised comprehensive ... Current literature indicates that CFPT was shown to be safe, non-invasive, and particularly effective in terms of UI recovery. CFPT could result in more ...