Reinnervation of the clitoris and/or vaginal surface in patients with a low spinal lesion or spina bifida: the TOMAX-procedure for Wome

Recruiting

Conditions: gewaarwording van urine-continentie
Absence of genital sensation due to lower spinal lesion or spina bifida
10041543
10040480

Registration Number: NL-OMON55659

Lead Sponsor: Isala Klinieken

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Patients will be evaluated pre-operatively and four times postoperatively (at<br /><br>2weeks, 6,12 and 18 months):<br /><br>- Neurological sensory tests for touch and temperature stimuli<br /><br>- Quantitative fine-touch sensitivity will be determined using Semmes-Weinstein<br /><br>monofilaments</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Psychological functioning and sexuality will be evaluated pre-operatively and<br /><br>once postoperatively (at 18 months) by using:<br /><br>- the Hospital Depression and Anxiety Scale (HADS) questionnaire to determine<br /><br>the patients* level of distress<br /><br>- the Symptom Check list-90-R (SCL90-R) to measure psychoneuroticism.<br /><br>- the Groninger Arousability Scale (GAS)16 to assess the patients ability to<br /><br>experience the stages of the sexual response cycle.<br /><br>- FSDS-R proxymeasure voor sexual distress<br /><br>- FSFI a questionnary for sexually active women<br /><br>- SESII-W an inhibition / excitation questionnary<br /><br><br /><br><br /><br>These tests will be measured by a clinical psychologist trained in sexuology</p><br>