Partner responses to sildenafil citrate (Viagra) treatment of erectile dysfunction.
ABSTRACT To evaluate in a pooled analysis of multiple studies the perceptions of effectiveness and overall treatment satisfaction in the partners of patients who received sildenafil citrate for treatment of erectile dysfunction. Partner satisfaction with treatment of erectile dysfunction can have a substantial impact on the continuation of therapy.
Each partner rated the man's erectile function and her own intercourse satisfaction by responding to three appropriately modified questions from the International Index of Erectile Function, assessing frequency of erections, ability to maintain erections, and satisfaction of intercourse in 14 double-blind placebo-controlled trials of sildenafil. Partner satisfaction with sildenafil treatment was evaluated using the Erectile Dysfunction Inventory of Treatment Satisfaction partner questionnaire in six of these trials.
Of 3634 patients enrolled in these 14 trials, the partners of 930 patients agreed to participate. The partners reported that men receiving sildenafil had significantly greater erection frequency and ability to maintain erections than men receiving placebo, irrespective of patient age. Partners of sildenafil-treated men also had more frequent intercourse satisfaction compared with partners of placebo-treated men (P <0.0001). In both treatment groups, the partner and patient responses correlated highly (P <0.0001). The correlation between patient and partner Erectile Dysfunction Inventory of Treatment Satisfaction index scores was 0.80 for placebo and 0.86 for sildenafil (P <0.0001).
Partner evaluations corroborated the patient assessments, with both indicating that treatment with sildenafil resulted in statistically significant improvement in erectile function and suggesting that partners were satisfied with sildenafil treatment for erectile dysfunction.
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ABSTRACT: To evaluate the effect of tadalafil 5 mg taken once daily on efficacy (erection achievement and penetration) and overall sexual satisfaction in men with erectile dysfunction (ED) and their female partners. This retrospective analysis included data pooled from 2 multicenter, randomized, double-blind, placebo-controlled trials that included 505 couples (tadalafil, n=373; placebo, n=132) in which the men received tadalafil 5 mg once daily or placebo for 12 weeks. Individual Sexual Encounter Profile (SEP) diaries were completed independently by the male subject and his female partner after each sexual intercourse attempt. The mean per-subject/per-partner percentage of "yes" responses to SEP diary questions were assessed, as was agreement between subjects' and partners' responses. Subjects and partners in the tadalafil-treated group reported significantly greater improvements in the man's ability to achieve some erection, vaginal penetration, and overall sexual satisfaction compared with the placebo-treated group (P<.001). For all intercourse attempts, the mean per-couple percentage of agreement for those in the tadalafil and placebo groups, respectively, was high for erection achievement (99.0% and 96.6%), vaginal penetration (98.6% and 97.4%), and overall satisfaction (84.3% and 82.8%). Tadalafil 5 mg taken once daily as treatment for ED improved overall satisfaction for men and their female partners. This analysis demonstrates the high concordance among couples in their responses to the man's treatment for ED.Urology 03/2010; 75(6):1358-63. · 2.42 Impact Factor
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ABSTRACT: Research on relationships often does not refer to a single person but rather to two persons. Nonetheless, such data has been often analysed by examining individuals in isolation, which falls short of capturing their truly interpersonal and non-independent nature. This paper highlights and illustrates some analytic tools for such dyadic data that are essential for theories about dyadic relationships to be tested adequately. The methodology is applied to clinical trial data from male patients treated for their erectile dysfunction and data from their partners with respect to treatment satisfaction. Multi-level modelling was used to analyse the data. The approaches outlined allow researchers to assess both individual effects and companion effects (e.g. of baseline intercourse satisfaction on subsequent treatment satisfaction), role of participant (e.g. patient or partner) or treatment condition (e.g. test or placebo) on outcome (e.g. treatment satisfaction), and differences on individual and companion effects when couples differ on important variables (e.g. differences on the individual and companion effects of baseline intercourse satisfaction on treatment satisfaction when couples differ with respect to treatment condition). Researchers are encouraged to consider implementing dyadic data analysis in their own work.Journal of Evaluation in Clinical Practice 12/2010; 16(6):1340-4. · 1.51 Impact Factor
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ABSTRACT: Introduction. The HelpED study assessed men with erectile dysfunction (ED) treated with a phosphodiesterase type 5 (PDE5) inhibitor and their female partner in a community setting. Aim. To examine agreement in Erection Hardness Score (EHS) in patients and partners; to assess impact of EHS changes on other sexual health outcomes and behaviors. Methods. At baseline and follow-up 2 to 4 months later, men in a stable heterosexual relationship who had newly diagnosed or untreated ED (≥6 months) completed the single-item EHS, the International Index of Erectile Function questions 4 and 5 (assessing erection maintenance), the Self-Esteem And Relationship (SEAR) questionnaire, and a modified Quality of Life domain of the Sexual Life Quality Questionnaire (mSLQQ-QOL). Partners completed the EHS, Female Sexual Function Index, and the mSLQQ-QOL. Main Outcome Measures. EHS agreement assessed by Cohen weighted kappa coefficient, associations between change in EHS and change in measures of sexual function and quality of life; outcomes stratified by patient age (≤55 years vs. >55 years). Results. Questionnaires were completed by 447 men (64% aged 51-70 years) and 253 partners (52% aged 46-60 years) at baseline and by 266 and 152, respectively, at follow-up. At baseline, the consulting physician proposed PDE5 inhibitor treatment for 99% of patients, and EHS mean values were similar in patients and partners. All outcomes improved significantly (P < 0.05), including EHS in 75% of men (EHS3 [hardness sufficient for sexual intercourse but not fully hard] improved to EHS4 [fully hard erection] in almost 60%). For most other outcomes, improvement was greater in younger men and in those who improved from EHS3 to EHS4. Conclusions. Strong agreement in EHS between patient and partner and associations between improvement in EHS and improvements in measures of sexual function and quality of life in patients and partners support its clinical use in ED management. Claes HIM, Andrianne R, Opsomer R, Albert A, Patel S, and Commers K. The HelpED Study: Agreement and impact of the erection hardness score on sexual function and psychosocial outcomes in men with erectile dysfunction and their partners. J Sex Med **;**:**-**.Journal of Sexual Medicine 08/2012; 9(10):2652-63. · 3.51 Impact Factor