Study of Sexuality in Parkinson Disease (Sex-PD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier:
NCT01878409
First received: June 6, 2013
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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.


Condition
Parkinson Disease

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Study of Sexuality in Parkinson Disease

Resource links provided by NLM:


Further study details as provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:

Primary Outcome Measures:
  • BISF [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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:
  • BDI [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Beck Depression Inventory (BDI) is a 21.-item self report inventory, for measuring the severity of depression in clinical and nonclinical populations.

  • PDQ8 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Enrollment: 244
Study Start Date: January 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Parkinson Disease
Patients with Parkinson Disease
Healthy Subjects
Healthy Subjects

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed as having idiopathic PD were recruited from four Italian Movement Disorders Clinics

Criteria

Inclusion Criteria:

  • idiopathic PD
  • marital status
  • age 40-80

Exclusion Criteria:

  • patients taking PDE
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878409

Locations
Italy
Fondazione IRCCS Ca' Granda
Milano, Italy, 20122
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
Principal Investigator: Alberto Priori, MD,PhD Fondazione IRCCS Ca' Granda, Università di Milano
  More Information

No publications provided

Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT01878409     History of Changes
Other Study ID Numbers: 652
Study First Received: June 6, 2013
Last Updated: June 14, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Sexuality
Parkinson Disease
BISF
IIEF
FSFI

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on October 01, 2014