4-aminopyridine Treatment for Nerve Injury From Radical Retro-Pubic Prostatectomy
Study Details
Study Description
Brief Summary
The purpose of this study is to see if the study drug 4-aminopyridine (4-AP) can help speed up the recovery of peripheral nerve injury after prostatectomy. 4-AP is a potassium channel blocker used to improve walking in multiple sclerosis patients. Investigators will measure the effect that 4-AP may have on the recovery of sexual function and urinary incontinence after prostatectomy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 4-aminopyridine Participants with recent prostatectomies receiving 4-aminopyridine |
Drug: 4-aminopyridine
Oral tablet of 2.5 mg given 4 times a day
|
| Placebo Comparator: Placebo Participants with recent prostatectomies receiving placebo |
Drug: placebo
2.5 mg sugar pill given orally 4 times a day
|
Outcome Measures
Primary Outcome Measures
- percentage of participants with normal erectile dysfunction [2 months]
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Secondary Outcome Measures
- the time point at which the highest number of subjects reporting normal erectile dysfunction [baseline to month 12]
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
- percentage of participants with normal erectile dysfunction [week 3]
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
- percentage of participants with normal erectile dysfunction [week 4]
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
- percentage of participants with normal erectile dysfunction [week 6]
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
- percentage of participants with normal erectile dysfunction [week 8]
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
- percentage of participants with normal erectile dysfunction [week 10]
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
- percentage of participants with normal erectile dysfunction [week 12]
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
- percentage of participants with normal erectile dysfunction [week 14]
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
- percentage of participants with normal erectile dysfunction [week 16]
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
- percentage of participants with normal erectile dysfunction [week 18]
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
- percentage of participants with normal erectile dysfunction [week 20]
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
- percentage of participants with normal erectile dysfunction [week 22]
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
- percentage of participants with normal erectile dysfunction [week 24]
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
- percentage of participants with normal urinary continence [2 months]
Incontinence will be assessed using the Michigan Incontinence Symptom Index. The Michigan Incontinence Symptom Index ranges from 0-40 with higher scores indicating more problems with urinary incontinence.
Eligibility Criteria
Criteria
Inclusion Criteria
-
Male patients with organ-confined, non-metastatic prostate cancer (stages cT1c-T2c), planning to undergo Robotic-Assisted Laparoscopic Bilateral Nerve sparing radical prostatectomy (NSRP)
-
Prostate-specific antigen (PSA) levels less than 10 ng/ml, with biopsy-proven prostate cancer, for whom postoperative adjuvant therapy (e.g. radiation or androgen deprivation therapy) is not expected to be needed
-
Ages 45-75
-
An International Index of Erectile Function-Erectile Function (IIEF-5) score of greater than or equal to 17 at time of screening
-
Is sexually active for at least 6 months with sexual activity within 6 weeks preceding prostate biopsy or surgery.
-
Willingness to participate and able to provide informed consent
Exclusion Criteria
-
Planned adjuvant therapy after NSRP based on specimen pathology and stage of prostate cancer (stage T3 or greater), positive lymph nodes or positive surgical margins.
-
History of prior phosphodiesterase inhibitor use
-
Neo-adjuvant therapy prior to NSRP
-
History of recurrent prostate cancer
-
History of seizures, multiple sclerosis, stroke or any other diagnosed neurological disorder
-
History of non-organ confined or metastatic prostate cancer (clinical Stages T3 or greater)
-
History of known hypersensitivity to AMPYRA® or 4-aminopyridine
-
Patients with history of penile surgery other than circumcision or endoscopic urethral stricture surgery.
-
Renal impairment based on calculated GFR (GFR<60 mL/min)
-
Use of any other aminopyridine medications for any other indication
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Rochester Medical Center | Rochester | New York | United States | 14642 |
Sponsors and Collaborators
- University of Rochester
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 72666