NCT05749471

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

4.2 years

First QC Date

February 18, 2023

Last Update Submit

February 18, 2023

Conditions

Chronic Venous InsufficiencySexual Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evolution od sexual dysfunction after CVD treatments

    12 months

Study Arms (1)

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.

Diagnostic Test: ASEX (Arizona Sexual Experience) administration

Interventions

ASEX (Arizona Sexual Experience) administrationDIAGNOSTIC_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.

Patients with chronic venous disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of both sex, with minimum age of 18, with first diagnosis of Chronic Venous Disease.

You may qualify if:

  • \- patients with first diagnosis of Chronic Venous Disease

You may not qualify if:

  • presence of known sexual dysfunction of organic origin.
  • presence of arterial system diseases.
  • presence of malignancies.
  • presence of endocrine system disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Magna Graecia of Catanzaro

Catanzaro, 88100, Italy

RECRUITING

Related Publications (5)

  • 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.

    PMID: 32236977BACKGROUND

  • 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.

    PMID: 36768250RESULT

  • 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.

    PMID: 29962650RESULT

  • 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.

    PMID: 36718173RESULT

  • 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.

    PMID: 10693114RESULT

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Raffaele Serra, M.D.; P.h.D.

    University Magna Graecia of Catanzaro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+3909613647380rserra@unicz.iy

Davide Costa

CONTACT

+3909613647380davide.costa@unicz.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Vascular Surgery

Study Record Dates

First Submitted

February 18, 2023

First Posted

March 1, 2023

Study Start

January 1, 2019

Primary Completion

March 31, 2023

Study Completion

April 30, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)