Tags

Type your tag names separated by a space and hit enter

Nightly vs on-demand sildenafil for penile rehabilitation after minimally invasive nerve-sparing radical prostatectomy: results of a randomized double-blind trial with placebo.
BJU Int. 2013 Oct; 112(6):844-51.BI

Abstract

OBJECTIVES

To clarify the role of phosphodiesterase type 5 (PDE5) inhibitors in post-prostatectomy penile rehabilitation (PPPR). To compare nightly and on-demand use of PDE5 inhibitors after nerve-sparing minimally invasive radical prostatectomy (RP).

PATIENTS AND METHODS

We conducted a single-institution, double-blind, randomized controlled trial of nightly vs on-demand 50-mg sildenafil citrate after nerve-sparing minimally invasive RP. A total of 100 preoperatively potent men, aged <65 years, with scores on the Erectile Function domain of the International Index of Erectile Function (IIEF-EF) ≥26, underwent nerve-sparing surgery. The patients were randomized to either nightly sildenafil and on-demand placebo (nightly sildenafil group), or on-demand sildenafil and nightly placebo (on-demand sildenafil group; maximum on-demand dose six tablets/month) for 12 months. Patients then underwent a 1-month washout period. Validated measures of erectile function (IIEF-EF score and the Expanded Prostate Cancer Index Composite [EPIC]) were compared between treatment groups over the entire 13-month time course, using multivariable mixed linear regression models.

RESULTS

The treatment groups were well matched preoperatively (mean age 54.3 vs 54.6 years, baseline IIEF-EF score 29.4 vs 29.3, for the nightly vs the on-demand sildenafil groups, respectively). No significant differences were found in erectile function between treatments (nightly vs on-demand sildenafil) at any single timepoint after RP, after adjusting for potential confounding factors. When evaluated over all timepoints simultaneously, no significant effects of treatment group (nightly vs on-demand sildenafil) were found on recovery of potency, as assessed by absolute IIEF-EF scores (P = 0.765), on percentage of men returning to an IIEF-EF score >21 (P = 0.830), or on IIEF-EF score recovery to a percentage of baseline value (P = 0.778). When evaluated over all timepoints simultaneously, no significant effects of treatment group were found on secondary endpoints such as assessment of potency (including EPIC item 59 response 'erections firm enough for intercourse'), attempted intercourse frequency or confidence.

CONCLUSIONS

Erectile recovery up to 1 year after RP does not differ between previously potent men who use sildenafil nightly compared to on-demand. This trial does not support chronic nightly sildenafil as being any better than on-demand sildenafil for use in penile rehabilitation after nerve-sparing minimally invasive RP.

Authors+Show Affiliations

James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore, MD, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23937708

Citation

Pavlovich, Christian P., et al. "Nightly Vs On-demand Sildenafil for Penile Rehabilitation After Minimally Invasive Nerve-sparing Radical Prostatectomy: Results of a Randomized Double-blind Trial With Placebo." BJU International, vol. 112, no. 6, 2013, pp. 844-51.
Pavlovich CP, Levinson AW, Su LM, et al. Nightly vs on-demand sildenafil for penile rehabilitation after minimally invasive nerve-sparing radical prostatectomy: results of a randomized double-blind trial with placebo. BJU Int. 2013;112(6):844-51.
Pavlovich, C. P., Levinson, A. W., Su, L. M., Mettee, L. Z., Feng, Z., Bivalacqua, T. J., & Trock, B. J. (2013). Nightly vs on-demand sildenafil for penile rehabilitation after minimally invasive nerve-sparing radical prostatectomy: results of a randomized double-blind trial with placebo. BJU International, 112(6), 844-51. https://doi.org/10.1111/bju.12253
Pavlovich CP, et al. Nightly Vs On-demand Sildenafil for Penile Rehabilitation After Minimally Invasive Nerve-sparing Radical Prostatectomy: Results of a Randomized Double-blind Trial With Placebo. BJU Int. 2013;112(6):844-51. PubMed PMID: 23937708.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Nightly vs on-demand sildenafil for penile rehabilitation after minimally invasive nerve-sparing radical prostatectomy: results of a randomized double-blind trial with placebo. AU - Pavlovich,Christian P, AU - Levinson,Adam W, AU - Su,Li-Ming, AU - Mettee,Lynda Z, AU - Feng,Zhaoyong, AU - Bivalacqua,Trinity J, AU - Trock,Bruce J, Y1 - 2013/08/13/ PY - 2013/8/14/entrez PY - 2013/8/14/pubmed PY - 2013/11/20/medline KW - erectile dysfunction KW - penile rehabilitation KW - phosphodiesterase type 5 inhibitor KW - radical prostatectomy KW - sildenafil citrate SP - 844 EP - 51 JF - BJU international JO - BJU Int VL - 112 IS - 6 N2 - OBJECTIVES: To clarify the role of phosphodiesterase type 5 (PDE5) inhibitors in post-prostatectomy penile rehabilitation (PPPR). To compare nightly and on-demand use of PDE5 inhibitors after nerve-sparing minimally invasive radical prostatectomy (RP). PATIENTS AND METHODS: We conducted a single-institution, double-blind, randomized controlled trial of nightly vs on-demand 50-mg sildenafil citrate after nerve-sparing minimally invasive RP. A total of 100 preoperatively potent men, aged <65 years, with scores on the Erectile Function domain of the International Index of Erectile Function (IIEF-EF) ≥26, underwent nerve-sparing surgery. The patients were randomized to either nightly sildenafil and on-demand placebo (nightly sildenafil group), or on-demand sildenafil and nightly placebo (on-demand sildenafil group; maximum on-demand dose six tablets/month) for 12 months. Patients then underwent a 1-month washout period. Validated measures of erectile function (IIEF-EF score and the Expanded Prostate Cancer Index Composite [EPIC]) were compared between treatment groups over the entire 13-month time course, using multivariable mixed linear regression models. RESULTS: The treatment groups were well matched preoperatively (mean age 54.3 vs 54.6 years, baseline IIEF-EF score 29.4 vs 29.3, for the nightly vs the on-demand sildenafil groups, respectively). No significant differences were found in erectile function between treatments (nightly vs on-demand sildenafil) at any single timepoint after RP, after adjusting for potential confounding factors. When evaluated over all timepoints simultaneously, no significant effects of treatment group (nightly vs on-demand sildenafil) were found on recovery of potency, as assessed by absolute IIEF-EF scores (P = 0.765), on percentage of men returning to an IIEF-EF score >21 (P = 0.830), or on IIEF-EF score recovery to a percentage of baseline value (P = 0.778). When evaluated over all timepoints simultaneously, no significant effects of treatment group were found on secondary endpoints such as assessment of potency (including EPIC item 59 response 'erections firm enough for intercourse'), attempted intercourse frequency or confidence. CONCLUSIONS: Erectile recovery up to 1 year after RP does not differ between previously potent men who use sildenafil nightly compared to on-demand. This trial does not support chronic nightly sildenafil as being any better than on-demand sildenafil for use in penile rehabilitation after nerve-sparing minimally invasive RP. SN - 1464-410X UR - https://www.unboundmedicine.com/medline/citation/23937708/Nightly_vs_on_demand_sildenafil_for_penile_rehabilitation_after_minimally_invasive_nerve_sparing_radical_prostatectomy:_results_of_a_randomized_double_blind_trial_with_placebo_ L2 - https://doi.org/10.1111/bju.12253 DB - PRIME DP - Unbound Medicine ER -