Clinical assessment of women with Persistent Genital Arousal Syndrome (PGAS) by quantitative sensory testing (QST) and cornea confocal microscopy (CCM)

Recruiting

• Conditions: persistent genital arousal syndrome; 10034606

• Registration Number: NL-OMON52300
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-12-04
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion 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

Exclusion Criteria

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)
- 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
<p>The primary endpoint is the description of sensory testing abnormalities in the<br /><br>genital region in PGAS patients and healthy controls.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To determine if sensory abnormalities in PGAS patients are isolated to the<br /><br>genital region or show a generalized distribution<br /><br>2. To assess if PGAS is associated with central sensitization<br /><br>3. To correlate PGAS symptoms to psychological characteristics<br /><br>4. To compare psychophysical characteristics between PGAS patients and healthy<br /><br>controls<br /><br>5. To relate the severity of PGAS symptoms to outcomes in psychophysical<br /><br>evaluation</p><br>