Study of Sexuality in Parkinson Disease

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT01878409
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary

The aim of this study is to evaluate the different aspects of sexual function among adults with Parkinson Disease to develop a treatment and address sexual problems as a routine part of diagnostic workup and therapeutic planning.

Detailed Description

Because there is limited literature on sexual function in Parkinson disease, in this study, we examined sexual functioning in a large groups of patients with idiopathic Parkinson Disease compared with healthy subjects in the Italian community. To assess sexual function in PD we used the Brief Index of Sexual Functioning \[(BISF-M for man; BISF-W for woman), the International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI). Participants were also assessed by the Beck Depression Inventory (BDI).

This study aimed to provide a thorough epidemiological description of sexual dysfunction in Parkinson's disease. The knowledge of sexual function in PD might help to plan effective interventionist measures and ultimately to optimize patient's and the partner's quality of life.

Parkinson patients (aged 40-80) and 123 healthy controls (aged 40-80) will be recruited from four Italian Movement Disorders Clinics.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-06
• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-06-14
• Last Update Submitted: 2013-06-14
• Study First Posted: 2013-06-17
• Last Update Posted: 2013-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

• idiopathic PD
• marital status
• age 40-80

Exclusion Criteria

• patients taking PDE

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BISF	Baseline	Brief Index of Sexual Functioning (BISF-M for man; BISF-W for woman)International Index of Erectile Function (IIEF) Female Sexual Function Index (FSFI)

Secondary Outcome Measures

Name	Time	Method
BDI	Baseline	Beck Depression Inventory (BDI) is a 21.-item self report inventory, for measuring the severity of depression in clinical and nonclinical populations.
PDQ8	Baseline	Parkinson' Disease Questionnaire-8 (PDQ- 8) is a self completion PRO designed to address aspects of functioning and well-being for those affected by Parkinson's disease.

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda; 🇮🇹 Milano, Italy