Status:
TERMINATED
Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Pfizer
Conditions:
Penile Cancer
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
When a bilateral nerve-sparing radical prostatectomy (RP) is performed, recovery of erectile function (rigid erections) is reported for up to 80% of patients, who are less than 60 years old. Erectile ...
Eligibility Criteria
Inclusion
- Male, must be ≥ 18 years of age, with histologically confirmed prostate adenocarcinoma, that is clinically localized to the prostate gland
- Stable sexual relationship for ≥ 6 months
- Open or laparoscopic bilateral nerve-sparing radical prostatectomy
- Baseline score of ≥ 22 on the International Index of Erectile Function Domain (Appendix A)
- Able to speak, read and write in the English language
- Calculated creatinine clearance using the 4 variable MDRD equation based on serum creatinine, age, race, and gender of \> 60 cc/min
- Patient is able to walk up two flights of stairs briskly without chest pain
- Patient needs to have their baseline sitting AND standing blood pressure and pulse done at the time of consent
Exclusion
- Preoperative or planned postoperative pelvic radiation therapy
- Preoperative or planned postoperative androgen deprivation
- Presence of Peyronie's disease at baseline
- Presence of a penile prosthesis at baseline
- Resection of one or both nerve bundles at surgery
- Any contraindications to sildenafil:
- Patient is currently using nitrates;
- Presence of retinitis pigmentosa;
- Presence macular degeneration;
- MI or CVA within 3 months;
- Patient is currently using MAOI medications
- Patient is currently using penile self injection medication (Trimix, Bimix, or PGE-1)
- Patient requiring sildenafil for penetration
- Use of sildenafil within 30 days of consent
Key Trial Info
Start Date :
August 6 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2020
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00955929
Start Date
August 6 2009
End Date
December 9 2020
Last Update
November 10 2021
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065