Rehabilitation and Sex Therapy for Prostate Cancer
(RESTORE-PC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness and acceptance of telehealth sex therapy following prostate cancer treatment. It includes men treated for localized prostate cancer at Duke Health. Participants receive pelvic floor physical therapy and education on penile rehabilitation, with some also participating in online sex therapy sessions. Additionally, some participants use a vacuum erection device (VED) as part of their treatment. Eligible participants must have undergone prostate cancer treatment with nerve-sparing surgery or other specific treatments and be starting pelvic floor physical therapy as part of their care. As an unphased trial, this study allows participants to contribute to innovative approaches in post-cancer care.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, medicines for erectile function are prescribed as part of usual clinical care and are not part of the study treatment.
What prior data suggests that these therapies and devices are safe for prostate cancer rehabilitation?
Past studies have found pelvic floor physical therapy to be safe and effective for prostate cancer patients. Research shows that this therapy can greatly improve bladder control, with some patients experiencing no leakage within a month. By six months, almost all patients notice significant improvements.
Although less researched in this area, sex therapy is generally considered safe. It aims to enhance sexual health and intimacy after prostate cancer treatment, with no major safety issues reported.
The vacuum erection device (VED) also has strong research support. Studies have shown that about 85% of men experience better erections when using it. The device is considered safe and can help maintain penis size and function after treatment.
Overall, these therapies are well-tolerated and have shown positive results for those recovering from prostate cancer treatment.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a comprehensive approach to rehabilitation and sex therapy for prostate cancer patients. Unlike the standard care that typically focuses solely on pelvic floor physical therapy (PFPT) and penile rehabilitation using a vacuum erection device (VED), this trial combines these methods with ten 45-minute telehealth sex therapy sessions over six months. This integration of sex therapy aims to address both the physical and emotional aspects of recovery, potentially offering a more holistic treatment experience. By addressing psychological factors alongside physical rehabilitation, the hope is to improve overall quality of life and sexual health outcomes for patients.
What evidence suggests that this trial's treatments could be effective for prostate cancer rehabilitation?
Research has shown that pelvic floor physical therapy, one of the treatments in this trial, can significantly benefit men treated for prostate cancer. Studies indicate that up to 95% of patients who perform these exercises experience reduced urinary leakage within six months. This therapy strengthens the muscles controlling the bladder, which is crucial after prostate surgery.
Regarding sex therapy, another treatment option in this trial, while specific data for prostate cancer patients is lacking, therapy focusing on sexual health and relationships can enhance overall sexual satisfaction and intimacy. This approach is particularly helpful for those facing changes after cancer treatment. The trial will compare the effects of pelvic floor physical therapy alone with the combination of pelvic floor physical therapy and sex therapy, potentially offering comprehensive support for both physical and emotional recovery.12367Who Is on the Research Team?
Rebecca A Shelby, PhD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for adult men who have been treated for localized prostate cancer and are experiencing urinary incontinence or erectile dysfunction. Participants must be able to take part in physical therapy and telehealth sessions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline assessment occurs after completion of localized treatment and before initiation of study-linked rehabilitation
Treatment
Participants receive pelvic floor physical therapy and penile rehabilitation education. One group also receives telehealth sex therapy over 6 months.
Follow-up
Participants are monitored for safety and effectiveness after treatment with assessments at multiple time points
What Are the Treatments Tested in This Trial?
Interventions
- Pelvic Floor Physical Therapy
- Sex Therapy
- Vacuum Erection Device (VED)
Trial Overview
The study compares two approaches: pelvic floor physical therapy alone versus the same therapy plus sex therapy delivered by telehealth. All participants also get education on penile rehabilitation, including use of a vacuum erection device.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Ten 45-minute telehealth sex therapy sessions over 6 months plus standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED).
Standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED); no study-delivered sex therapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
Citations
Pelvic Floor Rehabilitation After Prostatectomy - PMC - NIH
Pelvic floor rehabilitation after RP is effective in improving continence, including in patients with severe baseline symptoms.
Effectiveness of Physical Therapy for Male Urinary ...
Pelvic floor physical therapy effectively improved UI outcomes in RP patients across all age groups, cancer stages, types of treatments received and duration ...
3.
hermanwallace.com
hermanwallace.com/blog/pelvic-floor-rehabilitation-before-and-after-prostate-and-pelvic-cancer-treatmentPelvic Floor Rehabilitation Before and After Prostate and ...
Structured pelvic floor muscle training programs have consistently demonstrated improvements in urinary continence after radical prostatectomy.
Pelvic Floor Physical Therapy for Prostate Cancer
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.
Effectiveness of Early Pelvic Floor Rehabilitation Treatment ...
Results: In the treated group, 19% (29 patients) achieved continence after 1 month, and 94.6% (146 patients) after 6 months.
AskDHR • How Can Pelvic Floor Therapy Help with Prostate ...
Pelvic Floor Therapy continues to have positive outcomes in recovery for patients who have prostate cancer as we emphasize their safety with ...
How Pelvic Floor Physical Therapy Can Support Your ...
Studies show that men who do pelvic floor PT before surgery have 50% less urinary leakage afterward (Patel & Yao, 2020).
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