The primary aim is to investigate the effect of neuromodulation (via UCon) on the symptoms of patients with PGAD. The hypothesis we want to test is whether neuromodulation of the DGN reduces the severity of symptoms of PGAD.
ID
Source
Brief title
Condition
- Peripheral neuropathies
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures is the effect of neuromodulation on PGAD symptoms.
Secondary outcome
Secondary outcome measures include session duration, stimulation level and
frequency of neuromodulation; effect of neuromodulation on quality of life and
on mental health; and experiences of using UCon.
Background summary
UCon is a non-invasive modulator which stimulates the DGN through a patch
electrode and can relieve symptoms of overactive bladder and fecal
incontinence. A side effect of this neuromodulation is a change in sexual
function. It is expected that neuromodulation using UCon will lead to relief of
symptoms of PGAD, for which there are few other treatment options. As a result,
we hope to create a new effective treatment for patients with PGAD.
Study objective
The primary aim is to investigate the effect of neuromodulation (via UCon) on
the symptoms of patients with PGAD. The hypothesis we want to test is whether
neuromodulation of the DGN reduces the severity of symptoms of PGAD.
Study design
Pilot intervention study
Intervention
Each subject will be administered daily neuromodulation for a total of three
weeks, using UCon.
Study burden and risks
The burden for subjects in the NemoPGAD study consists of 1 additional visit
and completion of questionnaires. There are no risks associated with the use of
UCon. Subjects unable to operate UCon will be excluded.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Patiets diagnosed with PGAD
Exclusion criteria
- Patients < 18 years of age
- Incapacitated subjects
- Subjects unable to operate UCon
- Subjects in whom the anatomy of the genitals precludes proper placement of
electrodes
Design
Recruitment
Medical products/devices used
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 | NL83877.091.23 |