Reinnervation of the clitoris in patients with a low spinal lesion (Th12-L1) by nerve-transposition of the ilio-inguinal nerve towards the dorsal clotiridis nerve. By restoring the genital sensation in women with low spine lesion can increase the…
ID
Source
Brief title
Condition
- Other condition
- Spinal cord and nerve root disorders
- Sexual dysfunctions, disturbances and gender identity disorders
Synonym
Health condition
gewaarwording van urine-continentie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patients will be evaluated pre-operatively and four times postoperatively (at
2weeks, 6,12 and 18 months):
- Neurological sensory tests for touch and temperature stimuli
- Quantitative fine-touch sensitivity will be determined using Semmes-Weinstein
monofilaments
Secondary outcome
Psychological functioning and sexuality will be evaluated pre-operatively and
once postoperatively (at 18 months) by using:
- the Hospital Depression and Anxiety Scale (HADS) questionnaire to determine
the patients* level of distress
- the Symptom Check list-90-R (SCL90-R) to measure psychoneuroticism.
- the Groninger Arousability Scale (GAS)16 to assess the patients ability to
experience the stages of the sexual response cycle.
- FSDS-R *proxy*measure voor sexual distress
- FSFI a questionnary for sexually active women
- SESII-W an inhibition / excitation questionnary
These tests will be measured by a clinical psychologist trained in sexuology
Background summary
Background:
Almost all female patient with spina bifida have complete absence of
sensibility of the clitoris and vagina. The same thing is reported for women
with lower spinal injuries (dysfunction and sexual dysfunctie, do lead a normal life.
The psychosexual frustration in this female population is high. They can have
sexual interaction, but have complete absence of sensibility in the vagina and
clitoris.
Dr. M.L.E. Overgoor recently doctorated on the reinnervation of sensibility of
the penis with male lower spinal injuries or spina bifida by performing the so
called TOMAX-procedure. This involves micro-surgically connecting the sensory
ilioinguinal nerve (L1) to the dorsal nerve of the penis unilaterally. Tactile-
and erogenous-like sensibility was restored in the glans penis in patients with
a low spinal lesion. This new sensation enhanced the quality of sexual
functioning and satisfaction. Restoring genital sensation in women with low
spinal lesion can increase the quality of women*s sex lifes as well.
As a side effect a better control of urinary incontinency and awareness has
been reached in several patients.
The good results of this procedure with males has increased the interest of
female patients with lower cord injuries or spina bifida to perform a similar
procedure to reinnervate the clitoris and/or vagina. It is to be expected that
this procedure will enhance the quality of life, sexual functioning and
satisfaction.
Study objective
Reinnervation of the clitoris in patients with a low spinal lesion (Th12-L1) by
nerve-transposition of the ilio-inguinal nerve towards the dorsal clotiridis
nerve. By restoring the genital sensation in women with low spine lesion can
increase the quality of life, sexual functioning and satisfaction
As a side effect a improved awareness of urine incontinency can be expected.
Study design
A prospective trial, with an therapeutical intervention to reinnervate the
clitoris. There will not be a control group.
Intervention
Nerve transposition (ilioinguinal nerve to the dorsal nerve of the clitoris /
pudendal nerve) during an operation under local anesthesia (spinal block) or
general anesthesia.
Study burden and risks
Pre-operative:
- visit to out-patient clinic for physical examination and selection
- psychological test by sexuologist
Patients will be evaluatie at least 3 times postoperative:
1. Postoperative examination of the wound 2 weeks postoperative
2. out patient clinic visit for physical examination by the plastic surgeon 6
months postoperative
3. out patient clinic visit for physical examination by the plastic surgeon 12
months postoperative
4. out patient clinic visit for physical examination by the plastic surgeon 18
months postoperative and psychological tests by sexuologist.
- General complications following an operation:
- Loss of sensibility of the groin
- failure of the procedure which leads to the pre-operative condition of
absence of sensibility of the clitoris.
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
-Women with a (traumatic) low spinal lesion or spina bifida below L1 who have
no sensation in the clitoris and vaginal surface but with normal groin
sensation.
Exclusion criteria
- Spinal lesion above L1 and
- diminished or absent groin sensation
- negative sexual experiences
- psychologically unstable (estimated by our sexologist on the basis of
HADS/SCL-90 questionaries)
-intact clitoral/vaginal wall sensation
Design
Recruitment
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 | NL46780.075.15 |