Clinical assessment of women with Persistent Genital Arousal Syndrome (PGAS) by quantitative sensory testing (QST) and cornea confocal microscopy (CCM)
- Conditions
- PGAS
- Registration Number
- NL-OMON25394
- Lead Sponsor
- MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Adult, >18 years of age
- Able to give written informed consent
In addition, for PGAS patients:
- Diagnosed with PGAS, defined by the following criteria:
i. Involuntary genital and clitoral arousal that persists for an extended period of time (hours, days, months);
ii. The physical genital arousal does not go away following one or more orgasms;
iii. The genital arousal is unrelated to subjective feelings of sexual desire;
iv. The persistent feelings of genital arousal feel intrusive and unwanted; and
v. Feelings of distress.
In addition, for healthy controls:
- Not diagnosed with a pain syndrome
- Reporting an average daily pain score of NRS <2 (numerical rating scale score, range 0-10)
- No overactive bladder symptoms or other complaints of micturition
A potential subject who meets any of the following criteria will be excluded from participation in this study:
PGAS patients and healthy controls:
- Regular use of opioids (>3 of 7 days per week)
- Diagnosis of a central nervous system disease
- Inability to undergo quantitative sensory testing in the genital region (for whatever reason, as judged by the subject or investigator)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to study signs of small fiber neuropathy in PGAS patients compared to healthy controls
- Secondary Outcome Measures
Name Time Method Secondary objectives are:<br>1. To determine if sensory abnormalities in PGAS patients are isolated to the genital region or show a generalized distribution<br>2. To assess if PGAS is associated with central sensitization<br>3. To correlate PGAS symptoms to psychological characteristics<br>4. To compare psychophysical characteristics between PGAS patients and healthy controls<br>5. To relate the severity of PGAS symptoms to outcomes in psychophysical evaluation