Identification of Etiopathological and Clinical Factors in Persistent Genital Arousal Disorder

CompletedOBSERVATIONAL
Enrollment

52

Participants

Timeline

Start Date

June 1, 2020

Primary Completion Date

August 30, 2021

Study Completion Date

January 1, 2023

Conditions
Restless Genital SyndromeSexual Arousal DisorderOrgasmic DisorderPsychosexual Disorder
Interventions
DIAGNOSTIC_TEST

Psychological/psychiatric examination

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.

DIAGNOSTIC_TEST

Neurological examination

Standardized clinical neurological examination as well as neurophysiological measurements (Pudenus-SEP, ENoG, clinical EEG).

DIAGNOSTIC_TEST

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).

DIAGNOSTIC_TEST

Laboratory assessment

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.

DIAGNOSTIC_TEST

Structural and Functional Magnetic Resonance Imaging

"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, especially 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."

Trial Locations (1)

30625

Hannover Medical School, Hanover

All Listed Sponsors
lead

Hannover Medical School

OTHER

NCT04566783 - Identification of Etiopathological and Clinical Factors in Persistent Genital Arousal Disorder | Biotech Hunter | Biotech Hunter