Sex Dysfunction and Chronic Venous Disease

NCT ID: NCT05749471

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2023-04-30

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.

Conditions

Chronic Venous Insufficiency; Sexual Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with chronic venous disease

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 (Arizona Sexual Experience) administration

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Catanzaro

OTHER

Sponsor Role: lead

Responsible Party

Prof. Raffaele Serra, MD, Ph.D.

Associate Professor of Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raffaele Serra, M.D.; P.h.D.

Role: PRINCIPAL_INVESTIGATOR

University Magna Graecia of Catanzaro

Locations

University Magna Graecia of Catanzaro

Catanzaro, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Raffaele Serra, M.D.; P.h.D.

Role: CONTACT

rserra@unicz.iy

+3909613647380

Davide Costa

Role: CONTACT

davide.costa@unicz.it

+3909613647380

Facility Contacts

Raffaele Serra, M.D., Ph.D.

Role: primary

rserra@unicz.it

+3909613647380

Davide Costa

Role: backup

davide.costa@unicz.it

+3909613647380

References

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.

Reference Type: BACKGROUND

PMID: 32236977 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36768250 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29962650 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36718173 (View on PubMed)

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.

Reference Type: RESULT

PMID: 10693114 (View on PubMed)

Other Identifiers

ER.ALL.2018.61

Identifier Type: -

Identifier Source: org_study_id