Brief Summary

Investigation of (possible etiological) factors associated with PGAD symptomatology as well as description of comorbid disorders subjects with PGAD. Persistent genital arousal disorder (PGAD) is a presumably rare, although debilitating condition, which was first defined at the beginning of this century and has not yet found consideration by any of the international classification systems of diseases. PGAD is commonly characterized by persistent and unwanted sensations of genital arousal which are not related to subjective feelings of sexual desire or arousal. Affected patients which are predominantly women can suffer tremendously. The lack of basic research on the etiology of PGAD leads to insufficient therapeutical approaches.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

2.6 years study duration

Study Start

First participant enrolled

June 1, 2020

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2020

Completed

4 months until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed

Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

June 9, 2020

Last Update Submit

March 22, 2023

Conditions

Restless Genital Syndrome Sexual Arousal Disorder Orgasmic Disorder Psychosexual Disorder

Keywords

Persistant Genital Arousal DisorderPGAD

Outcome Measures

Primary Outcomes (5)

General outcome and target: Identification of clinical and neurobiological correlates of persistent genital arousal (PGAD)
1. gather a deeper clinical, (neuro)psychological and (neuro)biological understanding of PGAD 2. help to identify related etiopathological mechanisms of PGAD 3. inform clinicians and (sex) therapists on diagnostic issues and promising treatment targets in PGAD derived from comprehensive clinical and experimental measures 4. stimulate further neurobiological and clinical research in the field of PGAD, leading to further national and international cooperation and applications 5. publish a considerable number of publications in leading scientific journals and raise awareness of a rare disease not only among all clinicians dealing with sexual problems but also general practioners and others.
Data collection and avaluation through study completion. Data collection (examinations) will take 1 day (max 2) per subject. Data evaluation of all collected data will take about 1 year. Publication of findings will be an ongoing process afterwards.
Questionnaires: Psychological/Psychiatric, neurological and gynecological/urological assessments
Assessing sexual function (e.g. SIS/SES), depression and anxiety (HADS), childhood trauma (CTQ) and life quality (WHOQOL-BREF). In a semi-structured interview sociodemographic data, drug history and sexual characteristics are captured.
Data collection and avaluation through study completion. Data collection (examinations) will take 1 day (max 2) per subject. Data evaluation of all collected data will take about 1 year.
Clinical examinations: Psychological/Psychiatric, neurological and gynecological/urological assessments
1. Neuro)psychological assessment using standardized clinical interviews (e.g. MINI, SOMS). 2. Neurological examination: Standardized clinical neurological examination as well as neurophysiological measurements will be conducted (Pudenus-SEP, ENoG, clinical EEG). 3. Gynecological/urological examination: Standard clinical investigation including ultrasound of the genital organs will be conducted to look for any somatic pathology (e.g. varices, tumors).
Data collection and avaluation through study completion. Data collection (examinations) will take 1 day (max 2) per subject. Data evaluation of all collected data will take about 1 year.
Clinical and experimental imaging (MRI, fMRI)
1. Structural MRI of the pelvis is conducted to rule out any anatomical pathologies underlying PGAD (e.g. varices). 2. Structural MRI of the lumbosacral spinal cord to look for any pathologies on the spinal level (esp. spinal level S2-4 (e.g. Tarlov cysts)). 3. High-resolution structural MRI (T1) including brain stem will be applied to all participants in order to explore alterations in gray matter volume or density. 4. Structural differences in white matter will be assessed using a high-resolution DTI sequence. In addition to standard voxel-wise comparison of DTI derived parameters for white matter microstructural integrity, a tractography-based analysis will test for alterations in structural connectivity. 5. Resting-state functional MRI including brain stem scans will evaluate abnormal brain circuitry at rest (resting-state functional connectivity, RSFC). 6. Functional MRI to assess brain response towards sexual cue reactivity.
Data collection and avaluation through study completion. Data collection (examinations) will take 1 day (max 2) per subject. Data evaluation of all collected data will take about 1 year.
Laboratory assessments (blood samples)
Blood sample will be analyzed to evaluate (epi-)genetic markers of increased central excitability or decreased inhibition including specific parameters of the serotonin-, dopamine- and endocannabinoid system
Data collection and avaluation through study completion. Data collection (examinations) will take 1 day (max 2) per subject. Data evaluation of all collected data will take about 1 year.

Study Arms (2)

Women and men fulfilling PGAD-criteria

Inclusion criteria: \- Female and male patients or subjects between 18-65 years of age fulfilling the diagnostic criteria of persistent genital arousal disorder (PGAD) according to Leiblum \& Nathan (2001). Exclusion criteria: \- Any exclusion criteria for magnetic resonance imaging (MRI), mental retardation, severe and acute somatic or mental disease such as acute psychosis, brain damage, Alzheimer's disease, severe bacterial infection requiring immediate medical treatment. Age: \- 18 - 65 years of age Gender: \- Female and male subjects

Diagnostic Test: Psychological/psychiatric examinationDiagnostic Test: Neurological examinationDiagnostic Test: Gynecological/urological examinationDiagnostic Test: Laboratory assessmentDiagnostic Test: Structural and Functional Magnetic Resonance Imaging

Controls

Inclusion criteria: \- Age and education matched healthy controls.

Interventions

Psychological/psychiatric examinationDIAGNOSTIC_TEST

Thorough diagnostic and (neuro)psychological assessment using standardized clinical interviews (e.g. MINI, SOMS) as well as questionnaires assessing sexual function (e.g. SIS/SES), depression and anxiety (HADS), childhood trauma (CTQ) and life quality (WHOQOL-BREF). In a semi-structured interview sociodemographic data, drug history and sexual characteristics are captured.