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Effect of nightly versus on-demand vardenafil on recovery of erectile function in men following bilateral nerve-sparing radical prostatectomy.
Eur Urol. 2008 Oct; 54(4):924-31.EU

Abstract

BACKGROUND

To date, no data have been available from large, well-designed trials comparing on demand and nightly dosing of phosphodiesterase type 5 (PDE5) inhibitors on recovery of erectile function in postprostatectomy patients with erectile dysfunction (ED).

OBJECTIVE

To investigate the effect of early postoperative dosing with vardenafil, administered either nightly or on demand, compared with placebo on recovery of erectile function in men with ED following bilateral nerve-sparing radical prostatectomy (NSRP) surgery.

DESIGN, SETTING, AND PARTICIPANTS

A randomised, double-blind, double-dummy, multicentre, parallel group study conducted at 87 centres across Europe, Canada, South Africa, and the United States. For inclusion, patients had to be scheduled to undergo bilateral NSRP within 1 mo of screening and have a normal International Index of Erectile Function erectile function domain (IIEF-EF) score of > or =26 at screening. A total of 628 men, aged 18-64 yr, were randomised to treatment. Study design consisted of a 9-mo double-blind treatment period, a 2-mo single-blind washout period, and an optional 2-mo open-label period.

INTERVENTION

Patients received placebo, nightly vardenafil, or on demand vardenafil.

MEASUREMENTS

Primary outcome measure was the percentage of subjects with an IIEF-EF score of > or =22 after the 2-mo washout period. Secondary variables included mean per-patient success rates for Sexual Encounter Profile (SEP) questions 2 and 3.

RESULTS AND LIMITATIONS

No statistically significant differences were observed among treatment groups in the proportion of patients with an IIEF-EF score of > or =22 or in SEP3 success rates after the washout period. On-demand vardenafil treatment resulted in significantly greater IIEF-EF scores and better SEP3 response rates than placebo over the entire treatment period.

CONCLUSIONS

In this study of men with ED following bilateral NSRP, vardenafil was efficacious when used on demand, supporting a paradigm shift towards on demand dosing with PDE5 inhibitors in this patient group.

TRIAL REGISTRATION

European clinical trials database (EudraCT; available at http://eudract.emea.europa.eu/).

TRIAL REGISTRATION NUMBER

11336.

Authors+Show Affiliations

Division of Urology, Universita Vita Salute San Raffaele, Via Olgettina 60, Milan, Italy. montorsi.francesco@hsr.itNo 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
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18640769

Citation

Montorsi, Francesco, et al. "Effect of Nightly Versus On-demand Vardenafil On Recovery of Erectile Function in Men Following Bilateral Nerve-sparing Radical Prostatectomy." European Urology, vol. 54, no. 4, 2008, pp. 924-31.
Montorsi F, Brock G, Lee J, et al. Effect of nightly versus on-demand vardenafil on recovery of erectile function in men following bilateral nerve-sparing radical prostatectomy. Eur Urol. 2008;54(4):924-31.
Montorsi, F., Brock, G., Lee, J., Shapiro, J., Van Poppel, H., Graefen, M., & Stief, C. (2008). Effect of nightly versus on-demand vardenafil on recovery of erectile function in men following bilateral nerve-sparing radical prostatectomy. European Urology, 54(4), 924-31. https://doi.org/10.1016/j.eururo.2008.06.083
Montorsi F, et al. Effect of Nightly Versus On-demand Vardenafil On Recovery of Erectile Function in Men Following Bilateral Nerve-sparing Radical Prostatectomy. Eur Urol. 2008;54(4):924-31. PubMed PMID: 18640769.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of nightly versus on-demand vardenafil on recovery of erectile function in men following bilateral nerve-sparing radical prostatectomy. AU - Montorsi,Francesco, AU - Brock,Gerald, AU - Lee,Jay, AU - Shapiro,JoAnn, AU - Van Poppel,Hendrik, AU - Graefen,Markus, AU - Stief,Christian, Y1 - 2008/07/09/ PY - 2008/06/21/received PY - 2008/06/30/accepted PY - 2008/7/22/pubmed PY - 2009/1/16/medline PY - 2008/7/22/entrez SP - 924 EP - 31 JF - European urology JO - Eur Urol VL - 54 IS - 4 N2 - BACKGROUND: To date, no data have been available from large, well-designed trials comparing on demand and nightly dosing of phosphodiesterase type 5 (PDE5) inhibitors on recovery of erectile function in postprostatectomy patients with erectile dysfunction (ED). OBJECTIVE: To investigate the effect of early postoperative dosing with vardenafil, administered either nightly or on demand, compared with placebo on recovery of erectile function in men with ED following bilateral nerve-sparing radical prostatectomy (NSRP) surgery. DESIGN, SETTING, AND PARTICIPANTS: A randomised, double-blind, double-dummy, multicentre, parallel group study conducted at 87 centres across Europe, Canada, South Africa, and the United States. For inclusion, patients had to be scheduled to undergo bilateral NSRP within 1 mo of screening and have a normal International Index of Erectile Function erectile function domain (IIEF-EF) score of > or =26 at screening. A total of 628 men, aged 18-64 yr, were randomised to treatment. Study design consisted of a 9-mo double-blind treatment period, a 2-mo single-blind washout period, and an optional 2-mo open-label period. INTERVENTION: Patients received placebo, nightly vardenafil, or on demand vardenafil. MEASUREMENTS: Primary outcome measure was the percentage of subjects with an IIEF-EF score of > or =22 after the 2-mo washout period. Secondary variables included mean per-patient success rates for Sexual Encounter Profile (SEP) questions 2 and 3. RESULTS AND LIMITATIONS: No statistically significant differences were observed among treatment groups in the proportion of patients with an IIEF-EF score of > or =22 or in SEP3 success rates after the washout period. On-demand vardenafil treatment resulted in significantly greater IIEF-EF scores and better SEP3 response rates than placebo over the entire treatment period. CONCLUSIONS: In this study of men with ED following bilateral NSRP, vardenafil was efficacious when used on demand, supporting a paradigm shift towards on demand dosing with PDE5 inhibitors in this patient group. TRIAL REGISTRATION: European clinical trials database (EudraCT; available at http://eudract.emea.europa.eu/). TRIAL REGISTRATION NUMBER: 11336. SN - 0302-2838 UR - https://www.unboundmedicine.com/medline/citation/18640769/Effect_of_nightly_versus_on_demand_vardenafil_on_recovery_of_erectile_function_in_men_following_bilateral_nerve_sparing_radical_prostatectomy_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0302-2838(08)00821-X DB - PRIME DP - Unbound Medicine ER -