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Sex Dysfunction and Chronic Venous Disease

Sexual Dysfunction in Patients With Chronic Venous Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05749471
Acronym
SEXVENO
Enrollment
600
Registered
2023-03-01
Start date
2019-01-01
Completion date
2023-04-30
Last updated
2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Venous Insufficiency, Sexual Dysfunction

Brief 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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTASEX (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.

Sponsors

University of Catanzaro
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of sexual dysfunction at CVD diagnosis6 monthsCVD 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

Secondary

MeasureTime frameDescription
Evolution od sexual dysfunction after CVD treatments12 monthsCVD 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.

Countries

Italy

Contacts

Primary ContactRaffaele Serra, M.D.; P.h.D.
rserra@unicz.iy+3909613647380
Backup ContactDavide Costa
davide.costa@unicz.it+3909613647380

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026