Erectile Dysfunction Following Radical Prostatectomy
Conditions
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 4 years following radical prostatectomy surgery.
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 4 years post-surgery among men with normal baseline pre-surgical erectile function.
Interventions
DEVICEMED3000 topical gel
Topical gel that has been shown to improve erectile dysfunction when used as needed.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Medical device (MED3000)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whether the Erectile Function Domain of the International Index of Erectile Function Mean Change From Baseline Met or Exceeded the Minimally Clinically Important Difference (MCID) of 4 | 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) (units on a scale) and whether it met MCID criteria of change of mean 4 \[IIEF EF minimum score is 0, maximum score is 75, with higher scores representing improved erectile function); units on a scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of MED3000 Topical Gel (Self-Esteem and Relationship 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 (units on a scale) \[SEAR minimum score is 0, maximum score is 70, with higher scores representing improved outcomes); units on a scale |
| Change From Baseline in All Domains of the IIEF. | 12 weeks | The efficacy of MED3000 in patients at weeks 4, 8 and 12 (units on a scale). 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) (units on a scale) and whether it changed over time \[IIEF EF minimum score is 0, maximum score is 75, with higher scores representing improved erectile function\]; units on a scale |
| Adverse Events of MED3000 Topical Gel | 12 weeks | Treatment-related adverse events in male patients and female partners occurring during treatment with MED3000. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMartin Kathrins, MD
Brigham and Women's Hospital
Participant flow
Recruitment details
20 patients met all the eligibility criteria and enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| MED3000 Topical Gel Treatment All qualified enrolled patients will receive treatment with MED3000 topical gel on demand through the 12-week follow-up visits. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | MED3000 Topical Gel Treatment |
|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 4.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Whether the Erectile Function Domain of the International Index of Erectile Function Mean Change From Baseline Met or Exceeded the Minimally Clinically Important Difference (MCID) of 4
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) (units on a scale) and whether it met MCID criteria of change of mean 4 \[IIEF EF minimum score is 0, maximum score is 75, with higher scores representing improved erectile function); units on a scale
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MED3000 topical gel treatment | Whether the Erectile Function Domain of the International Index of Erectile Function Mean Change From Baseline Met or Exceeded the Minimally Clinically Important Difference (MCID) of 4 | 0.8 IIEF-EF difference (units on scale) | Standard Deviation 3.9 |
Secondary
Adverse Events of MED3000 Topical Gel
Treatment-related adverse events in male patients and female partners occurring during treatment with MED3000.
Time frame: 12 weeks
Secondary
Change From Baseline in All Domains of the IIEF.
The efficacy of MED3000 in patients at weeks 4, 8 and 12 (units on a scale)
Time frame: 12 weeks
Secondary
Efficacy of MED3000 Topical Gel on Post-prostatectomy Incontinence
The change from baseline in 24 hour pad weight and usage number per day at 12 weeks. (grams)
Time frame: 12 weeks
Secondary
Efficacy of MED3000 Topical Gel on Stretched Flaccid Penile Length
The change from baseline of the stretched flaccid penile length following 12-weeks of treatment
Time frame: 12 weeks
Secondary
Efficacy of MED3000 Topical Gel (Self-Esteem and Relationship Questionnaire)
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 (units on a scale) \[SEAR minimum score is 0, maximum score is 70, with higher scores representing improved outcomes); units on a scale
Time frame: 12 weeks
Secondary
The Change From Baseline in Urinary Incontinence Using the Expanded Prostate Cancer Index Composite (EPIC) (Efficacy)
The efficacy of MED3000 in patients at weeks 4, 8 and 12 (units on a scale) \[EPIC minimum score 18; maximum score 93, with higher scores representing improved function\]
Time frame: 12 weeks