Return of nocturnal erections and erectile function after bilateral nerve-sparing radical prostatectomy in men treated nightly with sildenafil citrate: subanalysis of a longitudinal randomized double-blind placebo-controlled trial

J Sex Med. 2008 Feb;5(2):476-84. doi: 10.1111/j.1743-6109.2007.00700.x. Epub 2007 Dec 14.

Abstract

Introduction: After bilateral nerve-sparing radical retropubic prostatectomy (BNSRRP), nocturnal and sexually mediated erections may help to preserve normal erectile function (EF).

Aim: To investigate nocturnal penile tumescence and rigidity (NPTR) in a subset (N = 54 men) from a randomized, double-blind trial (N = 76) of nightly sildenafil after BNSRRP.

Methods: Inclusion required preoperative "normal" EF (defined as a combined score of >/=8 for International Index of Erectile Function questions 3 (penetration) and 4 (maintained erection after penetration) and NPTR testing (>/=10 continuous minutes of >/=55% rigidity [R >/= 55%] at the base). Postoperative assessments were at weeks 4 (pretreatment), 16, 28, 40 (during 36 weeks of nightly prophylaxis: sildenafil 50 mg [N = 17], 100 mg [N = 18] or placebo [N = 19]), and 48 (after 8 weeks of no erectile dysfunction therapy, when "responders" were delineated by the defined normal EF and a "yes" response to "Over the past 4 weeks, have your erections been good enough for satisfactory sexual activity?"). Base and tip rigidity and tumescence were measured using penile plethysmography.

Main outcome measures: Duration of R >/= 55% and area under the curves for rigidity and tumescence.

Results: Postoperatively, rapid profound reduction in nocturnal EF was noted in all groups. There was a gradual dose-dependent improvement in base and tip rigidity in the sildenafil groups but little improvement in the placebo group. Eight weeks after treatment termination (48 weeks postoperatively), 24% (4/17) of 50-mg sildenafil recipients, 33% (6/18) of 100-mg sildenafil recipients, and 5% (1/19) of placebo recipients were responders. Tip R >/= 55% was the most discriminating NPTR measure between nonresponders and responders to sildenafil, in whom it regained baseline (preoperative) levels (whereas base R >/= 55% did not). It was most prolonged in responders to sildenafil 100 mg.

Conclusions: In our subset analysis, nightly sildenafil for 9 months post-BNSRRP objectively improved nocturnal erections and pharmaceutically unassisted EF.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Area Under Curve
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Erectile Dysfunction / drug therapy*
  • Erectile Dysfunction / etiology
  • Humans
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Minimally Invasive Surgical Procedures / adverse effects
  • Patient Satisfaction*
  • Penile Erection / drug effects*
  • Phosphodiesterase Inhibitors / therapeutic use*
  • Piperazines / therapeutic use*
  • Prostatectomy / adverse effects*
  • Prostatic Neoplasms / surgery
  • Purines / therapeutic use
  • Sildenafil Citrate
  • Sulfones / therapeutic use*
  • Time Factors
  • Treatment Outcome

Substances

  • Phosphodiesterase Inhibitors
  • Piperazines
  • Purines
  • Sulfones
  • Sildenafil Citrate