Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52300
Enrollment
60
Registered
2021-04-08
Start date
2021-07-02
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

persistent genital arousal syndrome

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the description of sensory testing abnormalities in the genital region in PGAS patients and healthy controls.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)