The COUPLES-project: a pooled analysis of patient and partner treatment satisfaction scale (TSS) outcomes following vardenafil treatment
Article first published online: 19 MAR 2007
Volume 99, Issue 4, pages 849–859, April 2007
How to Cite
Rosen, R. C., Fisher, W. A., Beneke, M., Homering, M. and Evers, T. (2007), The COUPLES-project: a pooled analysis of patient and partner treatment satisfaction scale (TSS) outcomes following vardenafil treatment. BJU International, 99: 849–859. doi: 10.1111/j.1464-410X.2006.06737.x
- Issue published online: 19 MAR 2007
- Article first published online: 19 MAR 2007
- Accepted for publication 17 November 2006
- erectile dysfunction;
- sexual partner;
- placebo-controlled trial;
- pooled analysis;
- treatment satisfaction
Michael G. Wyllie
Ian Eardley, UK
Jean Fourcroy, USA
Sidney Glina, Brazil
Julia Heiman, USA
Chris McMahon, Australia
Bob Millar, UK
Alvaro Morales, Canada
Michael Perelman, USA
Marcel Waldinger, Netherlands
To assess the influence of vardenafil on treatment satisfaction in men with erectile dysfunction (ED) and their female partners.
PATIENTS AND METHODS
This was a pooled analysis of three randomized, double-blind, placebo-controlled, 12-week studies of flexible-dose vardenafil vs placebo, in men with ED for ≥6 months (n = 788) and their untreated female partners. Measures of efficacy included the Treatment Satisfaction Scale (TSS), International Index of Erectile Function, Erectile Function domain (IIEF-EF), and Sexual Encounter Profile (SEP) questions 2 and 3 (SEP-2, ‘Were you able to insert your penis into your partner’s vagina?’; and SEP-3, ‘Did your erection last long enough for you to have sexual intercourse?’). In addition to the overall analysis, there was a subgroup analysis for potential moderators of response, e.g. whether patients who had undergone previous phosphodiesterase type 5 (PDE-5) treatment.
At baseline, least-squares (LS) mean scores for all TSS domains were similar in the vardenafil and placebo groups. After 12 weeks of treatment, vardenafil significantly improved the LS mean score for all domains compared with placebo, among both patients and their female partners (P < 0.0001, ‘last’-observation-carried- forward analysis). Absolute between- group differences in LS mean TSS scores (vardenafil − placebo) were: ease of erection (patients 23.4, partners 24.9), erectile function satisfaction (36.7 and 32.9), pleasure from sexual activity (23.0, 23.7), satisfaction with orgasm (27.6, 21.8), confidence to complete sexual activity (28.2, 32.5), and satisfaction with medication (37.4, 35.6). The benefits of vardenafil were greater in men who had undergone previous PDE-5-inhibitor treatment and men aged <45 years, while the overall pattern of benefit was similar in all examined subgroups. There were significant benefits with vardenafil in all other variables (IIEF-EF scores and positive response rates to SEP-2 and SEP-3).
Vardenafil significantly improved treatment satisfaction in men with ED, and in their partners. The results provide further evidence of the validity of the TSS.