Study of Sexuality in Parkinson Disease

Parkinson Disease Clinical Trial

— Sex-PD  

Official title:

Study of Sexuality in Parkinson Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878409
• Other study ID #: 652
• Status: Completed
• Phase: N/A
• First received: June 6, 2013
• Last updated: June 14, 2013
• Start date: January 2010
• Est. completion date: November 2012

Study information

• Verified date: June 2013
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• idiopathic PD

• marital status

• age 40-80

Exclusion Criteria:

• patients taking PDE

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BISF	Brief Index of Sexual Functioning (BISF-M for man; BISF-W for woman)International Index of Erectile Function (IIEF) Female Sexual Function Index (FSFI)	Baseline	No
Secondary	BDI	Beck Depression Inventory (BDI) is a 21.-item self report inventory, for measuring the severity of depression in clinical and nonclinical populations.	Baseline	No
Secondary	PDQ8	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.	Baseline	No