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Randomized, double-blind, placebo-controlled study of postoperative nightly sildenafil citrate for the prevention of erectile dysfunction after bilateral nerve-sparing radical prostatectomy

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Abstract

Four weeks after bilateral nerve-sparing radical retropubic prostatectomy, men with normal erectile function before surgery were randomized to double-blind sildenafil (50 or 100 mg) or placebo nightly for 36 weeks, followed by an 8-week drug-free period before assessment of erectile function. Enrollment was prematurely ceased and only 76 men completed because, assuming a placebo response rate similar to the published literature (for example, 34% in meta-analysis), the 25% response at blinded interim review suggested a lack of treatment effect. On the contrary, spontaneous erectile function (a combined score of ⩾8 for questions 3 and 4 of the International Index of Erectile Function and a positive response to ‘Were erections good enough for satisfactory sexual activity?’) occurred in only 4% of the placebo group (n=1 of 25) versus 27% (n=14 of 51, P=0.0156, Fisher's exact test) of the sildenafil group. Nightly sildenafil administration for 36 weeks after surgery markedly increased the return of normal spontaneous erections.

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Acknowledgements

This study was funded by Pfizer Inc. Editorial assistance was provided by Deborah M Campoli-Richards of Complete Healthcare Communications, Inc., and was funded by Pfizer Inc.

Author information

Author notes

  1. H Padma-Nathan, A R McCullough, L A Levine, L I Lipshultz, R Siegel, F Montorsi, F Giuliano and G Brock: R Siegel: R Siegel was an employee of Pfizer at the time of this research.

  2. The other members of the Study Group are Professor Robert Andrianne, Belgium; David Bell, Canada; Gregory Broderick, USA; Serge Carrier, Canada; Professor Beatrice Cuzin, France; Harry Jeoffrey Deeths, USA; Wayne Hellstrom, USA; Sender Herschorn, Canada; Ronald W Lewis, USA; Raymond C Rosen, USA; Ridwan Shabsigh, USA; Phillip Stricker, Australia.

Authors and Affiliations

  1. Department of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA

    H Padma-Nathan

  2. Department of Urology, New York University School of Medicine, New York University Medical Center, New York, NY, USA

    A R McCullough

  3. Department of Urology, Rush Medical College, Rush University, Chicago, IL, USA

    L A Levine

  4. Scott Department of Urology, Baylor College of Medicine, Houston, TX, USA

    L I Lipshultz

  5. Sexual Health Team, Pfizer Inc, New York, NY, USA

    R Siegel

  6. Department of Urology, University Vita Salute San Raffaele, Milan, Italy

    F Montorsi

  7. Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, Garches, France

    F Giuliano

  8. Department of Urology, University of Western Ontario, London, ON, Canada

    G Brock

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  1. H Padma-Nathan
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  2. A R McCullough
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  5. R Siegel
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  6. F Montorsi
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on behalf of the Study Group

Corresponding author

Correspondence to A R McCullough.

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Author Disclosures

Gerald Brock: Consultant, investigator for clinical research, and speakers bureau member for Pfizer Inc, Lilly-ICOS, Bayer, GSK, Johnson & Johnson, Coloplast and AMS.

Francois Giuliano: Investigator for clinical and preclinical research, meeting lecturer, and member of advisory board for Pfizer Inc, Bayer-GSK, Lilly-ICOS, Johnson & Johnson; preclinical research for Solvay Pharmaceuticals, Roche; investigator for preclinical research and meeting lecturer for Sanofi-Aventis.

Larry Levine: Consultant for Pfizer Inc, Lilly-ICOS, Auxillium, Johnson & Johnson; investigator for clinical research for Pfizer Inc, Bayer-GSK, Auxillium; lecturer for Pfizer Inc, Lilly-ICOS, Schering-Plough.

Larry Lipshultz: Consultant for Pfizer Inc, Lilly-ICOS, Auxillium, and Solvay Pharmaceuticals; investigator for clinical research for Pfizer Inc and Lilly-ICOS.

Andrew McCullough: Consultant for Pfizer Inc, Lilly-ICOS, Auxillium, Johnson & Johnson; investigator for clinical research for Pfizer Inc, Lilly-ICOS, Bayer-GSK, Guilford Pharmaceuticals, Ion Channel, Johnson & Johnson and Schering Plough; advisory board and lecturer for Pfizer Inc, Lilly-ICOS and Auxillium.

Francesco Montorsi: Consultant for American Medical System, Bayer-GSK, Johnson & Johnson, Lilly ICOS, Pfizer Inc and Takeda.

Harin Padma-Nathan: Consultant, received grant support (for this and other clinical trials) from, and participated in CME educational program for Pfizer Inc, Lilly-ICOS, Bayer-GSK, NexMed and Palatin Technologies.

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Padma-Nathan, H., McCullough, A., Levine, L. et al. Randomized, double-blind, placebo-controlled study of postoperative nightly sildenafil citrate for the prevention of erectile dysfunction after bilateral nerve-sparing radical prostatectomy. Int J Impot Res 20, 479–486 (2008). https://doi.org/10.1038/ijir.2008.33

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  • DOI: https://doi.org/10.1038/ijir.2008.33

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