Effects of tadalafil treatment after bilateral nerve-sparing radical prostatectomy: Quality of life, psychosocial outcomes, and treatment satisfaction results from a randomized, placebo-controlled phase IV study

BMC Urology

Volumn 15, Issue 1, 2015, Pages

  Patel, Hitendra R ^a   Ilo, Dapo ^b   Shah, Nimish ^c   Cuzin, Béatrice ^d   Chadwick, David ^e   Andrianne, Robert ^f   Henneges, Carsten ^g   Barry, Jane ^b   Hell Momeni, Katja ^g   Branicka, Julia ^h   Büttner, Hartwig ^g  

^a UNIVERSITY HOSPITAL OF NORTH NORWAY   (Norway)

^b Lilly UK   (United Kingdom)

^c ADDENBROOKE S HOSPITAL   (United Kingdom)

^d EDOUARD HERRIOT HOSPITAL   (France)

^e SOUTH TEES HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^f UNIVERSITY OF LIÈGE   (Belgium)

^g LILLY DEUTSCHLAND GMBH   (Germany)

^h Eli Lilly Polska Sp z oo   (Poland)

Author keywords

Erectile dysfunction; PDE5 inhibitor; Prostate cancer; Prostatectomy; Quality of life; Randomized clinical trial; Tadalafil; Urinary incontinence

Indexed keywords

TADALAFIL; VASODILATOR AGENT;

ARTICLE; ASSESSMENT OF HUMANS; BILATERAL NERVE SPARING RADICAL PROSTATECTOMY; CANCER SURGERY; CHANGES IN EXPANDED PROSTATE CANCER INDEX COMPOSITE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; ERECTILE DYSFUNCTION INVENTORY OF TREATMENT SATISFACTION; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OUTCOME ASSESSMENT; PATIENT SATISFACTION; PHASE 4 CLINICAL TRIAL; PROSTATE ADENOCARCINOMA; PROSTATECTOMY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SELF ESTEEN AND RELATIONSHIP QUESTIONNAIRE; SOCIAL PSYCHOLOGY; URINE INCONTINENCE; ADENOCARCINOMA; AGED; CLINICAL TRIAL; HUMAN RELATION; MIDDLE AGED; PROCEDURES; PROSTATIC NEOPLASMS; URINARY INCONTINENCE;

ADENOCARCINOMA; AGED; DOUBLE-BLIND METHOD; HUMANS; INTERPERSONAL RELATIONS; MALE; MIDDLE AGED; PATIENT SATISFACTION; PROSTATECTOMY; PROSTATIC NEOPLASMS; QUALITY OF LIFE; TADALAFIL; URINARY INCONTINENCE; VASODILATOR AGENTS;

EID: 84928734884     PISSN: None     EISSN: 14712490     Source Type: Journal    
DOI: 10.1186/s12894-015-0022-9     Document Type: Article

References (34)

1. Briganti A, Di Trapani E, Abdollah F, Gallina A, Suardi N, Capitanio U, et al. Choosing the best candidates for penile rehabilitation after bilateral nerve-sparing radical prostatectomy. J Sex Med. 2012;9:608-17.
2. Ficarra V, Novara G, Ahlering TE, Costello A, Eastham JA, Graefen M, et al. Systematic review and meta-analysis of studies reporting potency rates after robot-assisted radical prostatectomy. Eur Urol. 2012;62:418-30.
3. Mulhall JP, Donatucci CF, Chiles KA, Büttner H. Management of erectile dysfunction after radical prostatectomy. In: Patel HRH, Mould T, Joseph J, Delaney C, editors. Pelvic cancer surgery: modern breakthroughs and future advances. Verlag London: Springer; 2015. in press.
4. Montorsi F, Nathan HP, McCullough A, Brock GB, Broderick G, Ahuja S, et al. Tadalafil in the treatment of erectile dysfunction following bilateral nerve sparing radical retropubic prostatectomy: a randomized, double-blind, placebo controlled trial. J Urol. 2004;172:1036-41.
5. Montorsi F, Brock G, Lee J, Shapiro J, Van Poppel H, Graefen M, 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;54:924-31.
6. Hatzimouratidis K, Burnett AL, Hatzichristou D, McCullough AR, Montorsi F, Mulhall JP. Phosphodiesterase type 5 inhibitors in postprostatectomy erectile dysfunction: a critical analysis of the basic science rationale and clinical application. Eur Urol. 2009;55:334-47.
7. Padma-Nathan H, McCullough AR, Levine LA, Lipshultz LI, Siegel R, Montorsi F, 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. 2008;20:479-86.
8. Mulhall JP, Burnett AL, Wang R, McVary KT, Moul JW, Bowden CH, et al. A phase 3, placebo controlled study of the safety and efficacy of avanafil for the treatment of erectile dysfunction after nerve sparing radical prostatectomy. J Urol. 2013;189:2229-36.
9. Montorsi F, Brock G, Stolzenburg JU, Mulhall J, Moncada I, Patel HRH, et al. Effects of tadalafil treatment on erectile function recovery following bilateral nerve-sparing radical prostatectomy: a randomised placebo-controlled study (REACTT). Eur Urol. 2014;65:587-96.
10. Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology. 2000;56:899-905.
11. Sanda MG, Wei JT, Litwin MS. Scoring Instructions for the Expanded Prostate cancer Index Composite Short Form (EPIC-26). [ http://www.med.umich.edu/urology/research/EPIC/EPIC-26-Scoring-1.2007.pdf ]
12. Penson DF, McLerran D, Feng Z, Li L, Albertsen PC, Gilliland FD, et al. 5-year urinary and sexual outcomes after radical prostatectomy: results from the prostate cancer outcomes study. J Urol. 2005;173:1701-5.
13. Potosky AL, Davis WW, Hoffman RM, Stanford JL, Stephenson RA, Penson DF, et al. Five-year outcomes after prostatectomy or radiotherapy for prostate cancer: the prostate cancer outcomes study. J Natl Cancer Inst. 2004;96:1358-67.
14. Althof SE, Corty EW, Levine SB, Levine F, Burnett AL, McVary K, et al. EDITS: development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. Urology. 1999;53:793-9.
15. Cappelleri JC, Althof SE, Siegel RL, Shpilsky A, Bell SS, Duttagupta S. Development and validation of the self-esteem and relationship (SEAR) questionnaire in erectile dysfunction. Int J Impot Res. 2004;16:30-8.
16. Cappelleri JC, Rosen RC, Smith MD, Mishra A, Osterloh IH. Diagnostic evaluation of the erectile function domain of the international index of erectile function. Urology. 1999;54:346-51.
17. Stanford JL, Feng Z, Hamilton AS, Gilliland FD, Stephenson RA, Eley JW, et al. Urinary and sexual function after radical prostatectomy for clinically localized prostate cancer: the prostate cancer outcomes study. JAMA. 2000;283:354-60.
18. Kilminster S, Müller S, Menon M, Joseph JV, Ralph DJ, Patel HRH. Predicting erectile function outcome in men after radical prostatectomy for prostate cancer. BJU Int. 2012;110:422-6.
19. Harden JK, Sanda MG, Wei JT, Yarandi H, Hembroff L, Hardy J, et al. Partners' long-term appraisal of their caregiving experience, marital satisfaction, sexual satisfaction, and quality of life 2 years after prostate cancer treatment. Cancer Nurs. 2013;36:104-13.
20. Moncada I, De Bethencourt FR, Lledó-Garcia E, Romero J, Turbi C, Büttner H, et al. Effects of tadalafil once daily or on-demand versus placebo on time to recovery of erectile function in patients after bilateral nerve-sparing radical prostatectomy. World J Urol. 2014, Aug 26. [Epub ahead of print]
21. Forgue ST, Patterson BE, Bedding AW, Payne CD, Phillips DL, Wrishko RE, et al. Tadalafil pharmacokinetics in healthy subjects. Br J Clin Pharmacol. 2006;61:280-8.
22. Cameron AP, Suskind AM, Neer C, Hussain H, Montgomery J, Latini JM, et al. Functional and anatomical differences between continent and incontinent men post radical prostatectomy on urodynamics and 3T MRI: a pilot study. Neurourol Urodyn. 2014, Apr 21. [Epub ahead of print].
23. Ficarra V, Novara G, Rosen RC, Artibani W, Carroll PR, Costello A, et al. Systematic review and meta-analysis of studies reporting urinary continence recovery after robot-assisted radical prostatectomy. Eur Urol. 2012;62:405-17.
24. Nam RK, Herschorn S, Loblaw DA, Liu Y, Klotz LH, Carr LK, et al. Population based study of long-term rates of surgery for urinary incontinence after radical prostatectomy for prostate cancer. J Urol. 2012;188:502-6.
25. McVary KT, Monnig W, Camps Jr JL, Young JM, Tseng LJ, van den Ende G. Sildenafil citrate improves erectile function and urinary symptoms in men with erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, double-blind trial. J Urol. 2007;177:1071-7.
26. McVary KT, Roehrborn CG, Kaminetsky JC, Auerbach SM, Wachs B, Young JM, et al. Tadalafil relieves lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2007;177:1401-7.
27. Stief CG, Porst H, Neuser D, Beneke M, Ulbrich E. A randomised, placebo-controlled study to assess the efficacy of twice-daily vardenafil in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Eur Urol. 2008;53:1236-44.
28. Gandaglia G, Albersen M, Suardi N, Gallina A, Abdollah F, Castiglione F, et al. Postoperative phosphodiesterase type 5 inhibitor administration increases the rate of urinary continence recovery after bilateral nerve-sparing radical prostatectomy. Int J Urol. 2013;20:413-9.
29. Gacci M, Ierardi A, Rose AD, Tazzioli S, Scapaticci E, Filippi S, et al. Vardenafil can improve continence recovery after bilateral nerve sparing prostatectomy: results of a randomized, double blind, placebo-controlled pilot study. J Sex Med. 2010;7(1 Pt 1):234-43.
30. Filippi S, Morelli A, Sandner P, Fibbi B, Mancina R, Marini M, et al. Characterization and functional role of androgen-dependent PDE5 activity in the bladder. Endocrinology. 2007;148:1019-29.
31. Wittmann D, Carolan M, Given B, Skolarus TA, An L, Palapattu G, et al. Exploring the role of the partner in couples' sexual recovery after surgery for prostate cancer. Support Care Cancer. 2014;22:2509-15.
32. Wittmann DA, West B, Skolarus T, Montie J. Couples' sexual recovery trajectory after surgery for prostate cancer: change in sexual function, sexual satisfaction and dyadic satisfaction [abstract]. Soc Social Work Res. 2014 Annual Conference, San Antonio, Tx, January 15-19, 2014.
33. Castiglione F, Nini A, Briganti A. Penile rehabilitation with phosphodiesterase type 5 inhibitors after nerve-sparing radical prostatectomy: are we targeting the right patients? Eur Urol. 2014;65:673-4.
34. Pavlovich CP, Levinson AW, Su LM, Mettee LZ, Feng Z, Bivalacqua TJ, 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;112:844-51.