NCT05749471|Unknown
Sex Dysfunction and Chronic Venous Disease
SEXVENO
Sexual Dysfunction in Patients With Chronic Venous Disease
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SEXVENO
Sexual Dysfunction in Patients With Chronic Venous Disease
Sponsor study identifier
observational
600
1 country
1
Study Start
January 1, 2019
Actual (reported)Primary Completion
March 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Chronic Venous Disease (CVD) is a common clinical condition with a high prevalence in the western population that may affect quality of life (QoL) of affected patients for several adverse effects. Sexual dysfunction (SD) also partecipate in the QoL of people and has never specifically studied in CVD patients. The aim of this study is to study SD in CVD patients before and after treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2019
Actual (reported)February 18, 2023
Actual (reported)March 1, 2023
Actual (reported)March 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Prevalence of sexual dysfunction at CVD diagnosis
CVD patients will be evaluated for sexual dysfunction at the moment of first diagnosis of CVD. ASEX (Arizona Sexual Experience) scale will be used. ASEX is a five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30. Generally, a subject with a total ASEX score of \> 19, any one item with a score of \> 5, or any three items with a score of \> 4 would have sexual dysfunction
6 months
Evolution od sexual dysfunction after CVD treatments
12 months
Consecutive patients with chronic venous disease (CVD) that will be diagnosed, staged according to the CEAP (Clinical-Etiology-Anatomy-Pathophysiology) classification of CVD. ASEX (Arizona Sexual Experience) questionnaire will be administered to CVD patients at time 0 of study inclusion and after treatment of CVD at intervals of 6 months and 12 months after treatment.
ASEX is a five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30. Generally, a subject with a total ASEX score of \> 19, any one item with a score of \> 5, or any three items with a score of \> 4 would have sexual dysfunction.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients of both sex, with minimum age of 18, with first diagnosis of Chronic Venous Disease.
University Magna Graecia of Catanzaro
Catanzaro, 88100, Italy
Elnazer HY, Baldwin DS. Structured review of the use of the Arizona sexual experiences scale in clinical settings. Hum Psychopharmacol. 2020 May;35(3):e2730. doi: 10.1002/hup.2730. Epub 2020 Mar 31.
Costa D, Andreucci M, Ielapi N, Serraino GF, Mastroroberto P, Bracale UM, Serra R. Molecular Determinants of Chronic Venous Disease: A Comprehensive Review. Int J Mol Sci. 2023 Jan 18;24(3):1928. doi: 10.3390/ijms24031928.
Raffaele Serra, M.D.; P.h.D.
University Magna Graecia of Catanzaro
First Submitted
February 18, 2023
First Posted
March 1, 2023
Study Start
January 1, 2019
Actual (reported)Primary Completion
March 31, 2023
Estimated (date passed)Erbium Laser for Treatment of Vaginal Looseness and Sexual Dysfunction.
Contact the study team to confirm eligibility.
Agaba PA, Ocheke AN, Akanbi MO, Gimba ZM, Ukeagbu J, Mallum BD, Agaba EI. Sexual Functioning and Health-related Quality of Life in Men. Niger Med J. 2017 May-Jun;58(3):96-100. doi: 10.4103/nmj.NMJ_225_16.
Boyacioglu NE, Oflaz F, Karaahmet AY, Hodaei BK, Afsin Y, Tasabat SE. Sexuality, quality of life and psychological well-being in older adults: A correlational study. Eur J Obstet Gynecol Reprod Biol X. 2023 Jan 12;17:100177. doi: 10.1016/j.eurox.2023.100177. eCollection 2023 Mar.
McGahuey CA, Gelenberg AJ, Laukes CA, Moreno FA, Delgado PL, McKnight KM, Manber R. The Arizona Sexual Experience Scale (ASEX): reliability and validity. J Sex Marital Ther. 2000 Jan-Mar;26(1):25-40. doi: 10.1080/009262300278623.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 1, 2023
Record last verified: 2023-02
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