Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy
Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Penile Cancer; Erectile Dysfunction; Radical Prostatectomy
Intervention: Placebo QHS and sildenafil and questionnaires (Drug); Sildenafil and questionnaire (Drug); Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Memorial Sloan Kettering Cancer Center Official(s) and/or principal investigator(s): John Mulhall, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center
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 function recovery is also impacted by patient age, erectile function before
surgery, and the length of time after surgery.
Current evidence from studies suggests that developing erections is important, however,
these studies have been small, and the evidence is not definite. Animal studies suggest that
erection medication (Viagra, Levitra, Cialis) may protect erection tissue, even in the
absence of erections. However, the correct treatment plan is unknown. For example, how often
does a man need to take sildenafil (Viagra®) to protect his erectile function or to maximize
his erectile function recovery? Is only using erection medication enough for erectile
function recovery? Would penile injections, which almost ensure production of an erection,
be better than using sildenafil (Viagra®), or might a combination be even better at helping
recovery of erections? These are types of questions this study might answer.
Clinical Details
Official title: A Randomized Trial of Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Difference in the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) between the 3 groups at 24 months.
Secondary outcome: The time to return of spontaneous functional erections.The time for patients to respond to oral erectogenic therapy. The proportion of patients who have normalization of their erectile function (normalization of the EF domain of the IIEF).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States
Additional Information
Memorial Sloan Kettering Cancer Center
Starting date: August 2009
Last updated: February 26, 2015
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