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ID
Source
Brief title
Health condition
PGAS
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to study signs of small fiber neuropathy in PGAS patients compared to healthy controls
Secondary outcome
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
Background summary
Persistent genital arousal syndrome (PGAS) is characterized by involuntary genital and clitoral arousal that is unwanted and unrelated to subjective feelings of sexual desire. It is rare but with a major negative impact on affected women’s quality of life. The syndrome is likely due to a neuropathy of the nervus pudendus, but this patient population is hardly ever studied. The current study is designed to explore signs and symptoms in PGAS patients and perform psychophysical sensory testing to better understand neuropathy-related involvement in the PGAS syndrome.
Study objective
This study should therefore be considered an exploratory diagnostic trial with the a priori hypothesis that the PGAS complaints are related to a generalized form of small fiber neuropathy with -due to unknown reasons- the focus of complaints directed at the genital extremity.
Study design
single timepoint
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9496 |
| Other | METC LDD : P21.010 |