An observational study in Chronic Venous Insufficiency and Sexual Dysfunction, sponsored by University of Catanzaro. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by University of Catanzaro · Observational
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.
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.
189 studies on the registry are indexed under Venous Insufficiency; 16 are open to participants now.
This study's planned enrollment of 600 is above the median of 100 across 41 observational studies indexed under Venous Insufficiency.
Browse Venous Insufficiency studies →University of Catanzaro is the lead sponsor of 43 studies on the registry; 2 are open to participants now.
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Patients of both sex, with minimum age of 18, with first diagnosis of Chronic Venous Disease.
Exclusion Criteria:
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.
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.
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
Time frame: 6 months
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.
Time frame: 12 months
Plan to share: No
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University of Catanzaro