Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy

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/Phentholamine 1mg/Prostaglandin E1 10 mcgs/ml) and questionnaires (Drug)

Phase: N/A

Status: 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

Overall contact:
John Mulhall, MD, Phone: 646-422-4359

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.

Official title: A Randomized Trial of Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy

Study design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study

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 post-RP.

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).

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 ≥ 24 on the International Index of Erectile Function Domain

(Appendix A)

- 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 is unable to walk up two flights of stairs briskly without chest pain

Exclusion Criteria:

- None

John Mulhall, MD, Phone: 646-422-4359

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States; Recruiting
John Mulhall, MD

Memorial Sloan-Kettering Cancer Center

Starting date: August 2009
Ending date: August 2012
Last updated: September 29, 2009