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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55659
Enrollment
30
Registered
2016-08-30
Start date
2017-01-23
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Nerve transposition (ilioinguinal nerve to the dorsal nerve of the clitoris / pudendal nerve) during an operation under local anesthesia (spinal block) or general anesthesia.

Sponsors

Isala Klinieken
Lead Sponsor

Eligibility

Age
16 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)