Topical gel treatment for erectile dysfunction after prostate surgery
MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction
This study is testing a new gel to see if it can help men who have trouble getting erections after prostate surgery feel better and regain their sexual function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05673005 on ClinicalTrials.gov |
What this trial studies
This research evaluates the efficacy and safety of MED3000, a topical gel designed for on-demand treatment of erectile dysfunction in men who have undergone radical prostatectomy. The study focuses on men experiencing persistent erectile dysfunction 1.5 to 4 years post-surgery, particularly those with normal erectile function prior to the procedure. Participants will be assessed for improvements in erectile function using standardized questionnaires. The goal is to determine if this treatment can facilitate recovery of erectile function in this patient population.
Who should consider this trial
Good fit: Ideal candidates are men aged 40-70 who have undergone robotic bilateral nerve-sparing radical prostatectomy 18-36 months prior and have experienced erectile dysfunction despite other treatments.
Not a fit: Patients who have not undergone radical prostatectomy or those with severe erectile dysfunction or other contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve erectile function and quality of life for men suffering from erectile dysfunction after prostate surgery.
How similar studies have performed: Other studies have explored topical treatments for erectile dysfunction, but the specific approach of MED3000 in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men who underwent robotic bilateral nerve-sparing radical prostatectomy between 18 and 36 months prior to study commencement * Subjects are 18-48 months status-post radical prostatectomy * Subjects have any degree of erectile dysfunction based on IIEF questionnaire * Age 40 - 70 at study commencement * Diagnosed with low/intermediate-risk prostate cancer: * PSA \< 20 ng/ml * Gleason score =\< 8 * Prostate Cancer stage =\< T3a * Normal pre-radical prostatectomy erectile function (IIEF \>=26) or equivalent response on EPIC * Baseline erectile dysfunction at time of screening (despite use of erectogenic aids of any kind) and enrolment following washout (IIEF-ED domain \<=25) * Sexually active, in a stable heterosexual relationship for at least 6 months prior to screening * Able to understand and complete patient questionnaires * Serum prostate specific antigen (PSA) undetectable (no evidence of disease recurrence) * Able to consent to participate * Documented written informed consent from both patient and his female partner Exclusion Criteria: * Anatomical abnormalities in the genitalia or pelvic region such as severe phimosis * Post-Radical Prostatectomy complications that could impact safety or effectiveness of medical therapy for erectile function (treatment for pelvic hematoma, urinary or intestinal fistula, unresolved anastomotic leak) * Tumor upstaging beyond T3a * Incomplete / sub-total nerve sparing on either side * Previous or scheduled treatment with pelvic salvage radiotherapy and/or androgen deprivation therapy * Prior receipt of androgen deprivation therapy * Any other condition that would prevent the patient from completing the study, as judged by the Principal Investigator
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Martin Kathrins, MD — Brigham and Women's Hospital
- Study coordinator: Martin Kathrins
- Email: mkathrins@bwh.harvard.edu
- Phone: 617-732-6227
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.