Clinical trial NCT00955929: Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy
Official title: A Randomized Trial of Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Penile Cancer
Erectile Dysfunction
Radical Prostatectomy
Keywords: Penis
PLACEBO
SILDENAFIL CITRATE
TRIMIX
Bimix
Viagra
09-005
Erectile Dysfunction following Bilateral Nerve-Sparing
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2009-08-10
Enrollment: 76
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility 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

Primary outcomes:
measure: Difference in the Erectile Function (EF) Domain Score of the International Index of Erectile Function (IIEF) Between the 3 Groups at 24 Months.
timeFrame: 2 years
Secondary outcomes:
measure: The Time to Return of Spontaneous Functional Erections.
timeFrame: 2 years
measure: The Time for Patients to Respond to Oral Erectogenic Therapy.
timeFrame: 2 years
measure: The Proportion of Patients Who Have Normalization of Their Erectile Function (Normalization of the EF Domain of the IIEF).
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: John Mulhall, MD
role: PRINCIPAL_INVESTIGATOR
References: