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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25394

Enrollment

Registered

2021-05-27

Start date

2021-05-28

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

PGAS

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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

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) - 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)

Design outcomes

Secondary

Measure	Time frame
Secondary objectives are: 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	—

Measure

Time frame

Secondary objectives are: 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

—

Primary

Measure	Time frame
The primary objective of this study is to study signs of small fiber neuropathy in PGAS patients compared to healthy controls	—

Contacts

Public ContactMonique van Velzen

LUMC

m.van_velzen@lumc.nl0715262301

Outcome results