The primary objective of this study is to study signs of small fiber neuropathy in PGAS patients compared to healthy controls.
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the description of sensory testing abnormalities in the
genital region in PGAS patients and healthy controls.
Secondary outcome
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
The primary objective of this study is to study signs of small fiber neuropathy
in PGAS patients compared to healthy controls.
Study design
observational, case-control study
Study burden and risks
The PGAS patient population is a relatively understudied population. Knowledge
on the possible involvement of small fiber neuropathy and/or central pain
modulation abnormalities will yield benefits for treating physicians and
patients.
The risks associated with this study are small: they are related to possible
intruding questions and discomfort associated with genital sensory testing. For
the PGAS patient population this discomfort is assumed to be limited, as they
are more used to regular genital examination as part of clinical care.
For healthy controls, genital sensory testing may be uncomfortable, but not
risky per se. We think that a clear subject information sheet, as well as
verbal explanation, should inform the subject sufficiently on the study
procedures.
Altogether, the set-up of our study allows us to collect unique sensory
processing information from an understudied patient population. Connecting the
experimental data to clinical data and data from healthy controls, results in a
positive balance of benefits as compared to the possible risks of this study.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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)
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| CCMO | NL75869.058.20 |