NCT03406169

Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy

Patterns of Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy With and Without Penile Rehabilitation

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Brooke Army Medical Center · Federal
• Sex: Male
• Age: 30 Years – 89 Years
• Healthy volunteers: Accepted

Summary

The study is a prospective, randomized, double-blind, placebo-controlled drug study to evaluate the pattern of erectile function recovery after robotic assisted laparoscopic prostatectomy (RALP). We hope to illustrate that early and continuous therapy with either Sildenafil citrate or pentoxyfylline after nerve sparing RALP will promote improved erectile function.

Detailed description

Evaluation of erectile function with the International Index of Erectile Function Questionnaire (IIEF) and measurement of penile length any time between the prostate biopsy and 3 days prior to RALP will be performed. Patients will undergo a unilateral or bilateral nerve sparing-RALP. Patients will be randomized to receive either 25mg Viagra twice daily, 400mg pentoxifylline twice daily or placebo twice daily, starting on the first postoperative day after surgery and continuing for one year. The biostatistician generates a table of random numbers. 120 subjects anticipated to enroll at Brooke Army Medical Center will be divided into 3 groups, sildenafil, pentoxifylline or placebo. The randomization table will be given to the research pharmacist. Patients will have their erectile function evaluated at 3 months, 6 months, 9 months, and 12 months with IIEF and sexual intercourse diary. These visits are routine for post-operative care following a RALP, however, completion of the IIEF and sexual intercourse diary are being performed for study purposes. Patients will stop therapy at 12 months and penile length will be re-measured. Measurement of penile length will be done for study purposes at the standard 1 year post-operative follow up visit. Patient will undergo a 6 week washout period during which neither drug will be used, then repeat analysis of erectile function with IIEF will be performed, after which they may restart standard erectile dysfunction therapy as desired. This washout period and follow up will be for study purposes.

Conditions

• Erectile Dysfunction
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Sildenafil 25 MG Oral Tablet	twice a day dosing
DRUG	Pentoxifylline	400mg twice a day
OTHER	Placebo	placebo twice a day

Timeline

• Start date: 2017-02-13
• Primary completion: 2021-12-01
• Completion: 2022-03-01
• First posted: 2018-01-23
• Last updated: 2018-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study