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


N/A
18 Years
N/A
Open (Enrolling)
Male
Penile Cancer, Erectile Dysfunction, Radical Prostatectomy

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Difference in the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) between the 3 groups at 24 months.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

John Mulhall, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

09-005

NCT ID:

NCT00955929

Start Date:

August 2009

Completion Date:

August 2013

Related Keywords:

  • Penile Cancer
  • Erectile Dysfunction
  • Radical Prostatectomy
  • Penis
  • PLACEBO
  • SILDENAFIL CITRATE
  • TRIMIX
  • Bimix
  • Viagra
  • 09-005
  • Erectile Dysfunction following Bilateral Nerve-Sparing
  • Penile Neoplasms
  • Erectile Dysfunction

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021