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Improvement in sexual quality of life of the female partner following vardenafil treatment of men with erectile dysfunction: a randomized, double-blind, placebo-controlled study.
J Sex Med. 2011 Oct; 8(10):2831-40.JS

Abstract

INTRODUCTION

Erectile dysfunction (ED) impacts on both members of the couple. Female partners of men with ED are more likely to report reduced sexual quality of life than women whose partners do not have ED.

AIM

To assess vardenafil efficacy in men with ED and determine the effects of treatment on their female partner's sexual quality of life.

METHODS

Study participants comprised men aged 18-64 years with ED and their female partners. Eligible men had ED of ≥6 months' duration and a female partner who was motivated to support their ED treatment. Eligible women had a total Female Sexual Function Index score >23.55, indicating absence of significant sexual dysfunction. Following a 4-week screening period, men were randomized to treatment with vardenafil 10 mg or placebo, which could be titrated to 20 or 5 mg after 4 weeks.

MAIN OUTCOMES MEASURES

Primary efficacy variables were question 3 of the Sexual Encounter Profile questionnaire (SEP3) and the quality-of-life domain of the modified Sexual Life Quality Questionnaire (mSLQQ-QOL).

RESULTS

The intent-to-treat population included 343 couples, with 168 and 175 men receiving vardenafil or placebo, respectively. Vardenafil treatment significantly improved both erection maintenance and the female partners' sexual quality of life. Least squares (LS) mean SEP3 overall success rates after 12 weeks of treatment were 9.5 (baseline) vs. 67.2 (week 12) and 12.4 (baseline) vs. 24.2 (week 12) in the vardenafil and placebo groups, respectively (P < 0.0001). In female partners, LS mean mSLQQ-QOL scores were 28.8 (baseline) vs. 68.2 (last observation carried forward [LOCF]) in the vardenafil group and 24.6 (baseline) vs. 40.5 (LOCF) in the placebo group (P < 0.0001).

CONCLUSIONS

Vardenafil treatment of men with ED improved both their erectile function and the sexual quality of life of their female partners.

Authors+Show Affiliations

Department of Urology, Hospital Carlos Haya, Malaga, Spain. amartinmorales@terra.esNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

21679304

Citation

Martín-Morales, Antonio, et al. "Improvement in Sexual Quality of Life of the Female Partner Following Vardenafil Treatment of Men With Erectile Dysfunction: a Randomized, Double-blind, Placebo-controlled Study." The Journal of Sexual Medicine, vol. 8, no. 10, 2011, pp. 2831-40.
Martín-Morales A, Graziottin A, Jaoudé GB, et al. Improvement in sexual quality of life of the female partner following vardenafil treatment of men with erectile dysfunction: a randomized, double-blind, placebo-controlled study. J Sex Med. 2011;8(10):2831-40.
Martín-Morales, A., Graziottin, A., Jaoudé, G. B., Debruyne, F., Buvat, J., Beneke, M., & Neuser, D. (2011). Improvement in sexual quality of life of the female partner following vardenafil treatment of men with erectile dysfunction: a randomized, double-blind, placebo-controlled study. The Journal of Sexual Medicine, 8(10), 2831-40. https://doi.org/10.1111/j.1743-6109.2011.02352.x
Martín-Morales A, et al. Improvement in Sexual Quality of Life of the Female Partner Following Vardenafil Treatment of Men With Erectile Dysfunction: a Randomized, Double-blind, Placebo-controlled Study. J Sex Med. 2011;8(10):2831-40. PubMed PMID: 21679304.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improvement in sexual quality of life of the female partner following vardenafil treatment of men with erectile dysfunction: a randomized, double-blind, placebo-controlled study. AU - Martín-Morales,Antonio, AU - Graziottin,Alessandra, AU - Jaoudé,Gilbert Bou, AU - Debruyne,Frans, AU - Buvat,Jacques, AU - Beneke,Manfred, AU - Neuser,Dieter, Y1 - 2011/06/16/ PY - 2011/6/18/entrez PY - 2011/6/18/pubmed PY - 2012/2/4/medline SP - 2831 EP - 40 JF - The journal of sexual medicine JO - J Sex Med VL - 8 IS - 10 N2 - INTRODUCTION: Erectile dysfunction (ED) impacts on both members of the couple. Female partners of men with ED are more likely to report reduced sexual quality of life than women whose partners do not have ED. AIM: To assess vardenafil efficacy in men with ED and determine the effects of treatment on their female partner's sexual quality of life. METHODS: Study participants comprised men aged 18-64 years with ED and their female partners. Eligible men had ED of ≥6 months' duration and a female partner who was motivated to support their ED treatment. Eligible women had a total Female Sexual Function Index score >23.55, indicating absence of significant sexual dysfunction. Following a 4-week screening period, men were randomized to treatment with vardenafil 10 mg or placebo, which could be titrated to 20 or 5 mg after 4 weeks. MAIN OUTCOMES MEASURES: Primary efficacy variables were question 3 of the Sexual Encounter Profile questionnaire (SEP3) and the quality-of-life domain of the modified Sexual Life Quality Questionnaire (mSLQQ-QOL). RESULTS: The intent-to-treat population included 343 couples, with 168 and 175 men receiving vardenafil or placebo, respectively. Vardenafil treatment significantly improved both erection maintenance and the female partners' sexual quality of life. Least squares (LS) mean SEP3 overall success rates after 12 weeks of treatment were 9.5 (baseline) vs. 67.2 (week 12) and 12.4 (baseline) vs. 24.2 (week 12) in the vardenafil and placebo groups, respectively (P < 0.0001). In female partners, LS mean mSLQQ-QOL scores were 28.8 (baseline) vs. 68.2 (last observation carried forward [LOCF]) in the vardenafil group and 24.6 (baseline) vs. 40.5 (LOCF) in the placebo group (P < 0.0001). CONCLUSIONS: Vardenafil treatment of men with ED improved both their erectile function and the sexual quality of life of their female partners. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/21679304/Improvement_in_sexual_quality_of_life_of_the_female_partner_following_vardenafil_treatment_of_men_with_erectile_dysfunction:_a_randomized_double_blind_placebo_controlled_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)33272-0 DB - PRIME DP - Unbound Medicine ER -