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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05749471
Other study ID # ER.ALL.2018.61
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date April 30, 2023

Study information

Verified date February 2023
Source University of Catanzaro
Contact Raffaele Serra, M.D.; P.h.D.
Phone +3909613647380
Email rserra@unicz.iy
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

Chronic Venous Disease (CVD) is a widespread clinical condition with a high prevalence in the western world, affecting more than 10% in young adults and more than 70% in older individuals (age >70 years). CVD clinical manifestations vary from mild clinical signs, including varicose veins, to more advanced and severe signs such as. Lower limb edema, skin changes, and venous leg ulceration (VLU) which impact the quality of life (QoL) of affected patients. Sexual dysfunction (SD), generally affects QoL, and specifically SD has never been evaluated in CVD patients. Clinical stages are described by the CEAP (Clinical-Etiology-Anatomy-Pathophysiology) classification that is an internationally accepted standard for describing patients with CVD. CEAP defines the following clinical classes, C0 includes no visible or palpable signs of venous disease; C1 includes telangiectasia and reticular veins; C2 includes trunk VV of variable origin; C2r includes recurrent varicose veins; C3 includes lower limbs edema; C4a includes pigmentation or eczema; C4b includes lipodermatosclerosis or atrophie blanche; C4c includes corona phlebectatica; C5 includes healed ulcer; C6 includes active ulcer; C6r includes recurrent active ulcer. Moreover, each clinical class may be subcharacterized by a subscript indicating the presence (symptomatic, s) or absence (asymptomatic, a) of symptoms attributable to venous disease, such as leg heaviness, achy or tired legs, cramping, restless legs. The most severe form of CVD is defined Chronic Venous Insufficiency (CVI) and corresponds to C3-C6 classes of CEAP. For the treatment of CVD several strategy, often combined can be used such as the administration of vasoactive drugs (VADs), or the utilization of compression devices (elastic stockings or bandages) and several surgical or endovascular techniques. Regarding sex dysfunction there are several unidimensional self-report measures available for assessing sexual dysfunction, all of them with some advantages and limitations. One of the most scale used in this context, proved useful in several clinical contexts is the ASEX (Arizona Sexual Experience) scale that is considered extremely reliable, valid, and sensitive for measuring sexual dysfunction with optimal internal consistency. 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. The aim of this study is to evaluate sexual functioning with ASEX scale among patients with CVD, at various clinical stages, before and after treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date April 30, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients with first diagnosis of Chronic Venous Disease Exclusion Criteria: - presence of known sexual dysfunction of organic origin. - presence of arterial system diseases. - presence of malignancies. - presence of endocrine system disease.

Study Design


Intervention

Diagnostic Test:
ASEX (Arizona Sexual Experience) administration
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.

Locations

Country Name City State
Italy University Magna Graecia of Catanzaro Catanzaro

Sponsors (1)

Lead Sponsor Collaborator
University of Catanzaro

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

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.2023.1001 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Evolution od sexual dysfunction after CVD treatments CVD patients that resulted affected from sexual dysfunction related to CVD conditions, will be evaluated to find out if CVD treatment has been beneficial also to sexual dysfunction. ASEX (Arizona Sexual Experience) scale will be used as in outcome 1. 12 months
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