MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction
Study Details
Study Description
Brief Summary
The investigators are doing this research to evaluate the efficacy and safety of topical MED3000 therapy in men with persistent erectile dysfunction 1.5 to 3 years following radical prostatectomy surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
MED3000 is a topical gel that has been developed to treat patients with erectile dysfunction. The investigators postulate that on demand treatment with MED3000 can improve on-demand erectile function among men status-post radical prostatectomy, allowing for some endogenous cavernosal nerve function recovery for 1.5 to 3 years post-surgery among men with normal baseline pre-surgical erectile function.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MED3000 topical gel treatment All qualified enrolled patients will receive treatment with MED3000 topical gel on demand through the 12-week follow-up visits. |
Device: MED3000 topical gel
Topical gel that has been shown to improve erectile dysfunction when used as needed.
|
Outcome Measures
Primary Outcome Measures
- Effect of MED3000 topical gel on erectile function [12 weeks]
To investigate the effect of MED3000 topical gel for treatment of erectile dysfunction after nerve sparing prostatectomy (based on Erectile Function domain of the International Index of Erectile Function)
- Effect of MED3000 topical gel on erectile function after 12 weeks based on minimally clinically important difference [12 weeks]
To observe a mean change from baseline of the IIEF-EF domain in patients after nerve sparing prostatectomy treated with MED3000, assessed at treatment completion after 12 weeks, greater than or equal to the minimally clinically important difference (MCID) of 4.
Secondary Outcome Measures
- Efficacy of MED3000 topical gel (SEAR questionnaire) [12 weeks]
The efficacy of MED3000 in patients at weeks 4, 8 and 12 using: The change from baseline in Self-Esteem and Relationship (SEAR) questionnaire for men
- The change from baseline in Urinary incontinence using the Expanded Prostate Cancer Index Composite (EPIC) (Efficacy) [12 weeks]
The efficacy of MED3000 in patients at weeks 4, 8 and 12
- Change from baseline in all domains of the IIEF. [12 weeks]
The efficacy of MED3000 in patients at weeks 4, 8 and 12
- Efficacy of MED3000 topical gel on post-prostatectomy incontinence [12 weeks]
The change from baseline in 24 hour pad weight and usage number per day at 12 weeks.
- Efficacy of MED3000 topical gel on stretched flaccid penile length [12 weeks]
The change from baseline of the stretched flaccid penile length following 12-weeks of treatment
- Adverse events of MED3000 topical gel [12 weeks]
Treatment-related adverse events in male patients and female partners occurring during treatment with MED3000.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men who underwent robotic bilateral nerve-sparing radical prostatectomy between 18 and 24 months prior to study commencement
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Subjects are 18-36 months status-post radical prostatectomy
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Subjects have any degree of erectile dysfunction based on IIEF questionnaire
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Age 40 - 70 at study commencement
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Diagnosed with low/intermediate-risk prostate cancer:
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PSA < 20 ng/ml
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Gleason score =< 8
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Prostate Cancer stage =< T2b
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Normal pre-radical prostatectomy erectile function (IIEF >=26)
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Baseline erectile dysfunction at time of screening (despite use of erectogenic aids of any kind) and enrolment following washout (IIEF-ED domain <=25)
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Sexually active, in a stable heterosexual relationship for at least 6 months prior to screening
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Able to understand and complete patient questionnaires
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Serum prostate specific antigen (PSA) undetectable (no evidence of disease recurrence)
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Able to consent to participate
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Documented written informed consent from both patient and his female partner
Exclusion Criteria:
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Anatomical abnormalities in the genitalia or pelvic region such as severe phimosis
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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)
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Incomplete tumor removal (positive surgical margin)
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Tumor upstaging beyond T2b
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Incomplete / sub-total nerve sparing on either side
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Previous or scheduled treatment with pelvic salvage radiotherapy and/or androgen deprivation therapy
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Prior receipt of androgen deprivation therapy
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Any other condition that would prevent the patient from completing the study, as judged by the Principal Investigator
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Brigham and Women's Hospital
Investigators
- Principal Investigator: Martin Kathrins, MD, Brigham and Women's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021P002976