- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06908850
The Aim of This Research is to Better Understand How Complete Spinal Cord Injury May Change Erogenous Zones in Adult Males (QualiEroSCI)
Erogenous Zones in Adult Males After Complete Spinal Cord Injury
A complete spinal cord injury (SCI) in men is characterized by the total loss of motor skills and sensations below the injury. The loss of penile sensation, the erogenous zone primarily involved in sexual response, is involved in sexual dysfunction, impacting sexual pleasure and quality of life. The management of genito-sexual dysfunction is a priority for paraplegic patients, ahead of bladder-sphincter and motor functions. For tetraplegic patients, the restoration of genito-sexual functions is their second priority after the upper limb motor skills recovery (Anderson, 2004)(Anderson et al., 2007). Medical assistance is currently available to i) restore erectile function allowing penetrative sexual intercourse, ii) enable sperm collection for reproductive purposes, iii) assisted reproductive techniques which allowing most often these patients to achieve their fatherhood goals (Giuliano et al., 2019)(Chochina et al., 2016)(Lombardi et al., 2015). Nevertheless, the assessment and management of the loss of genital sensations have been poorly studied, alike sexual pleasure and satisfaction in SCI patients (Philpott et al., 2006).
Erogenous zones are regions of the body that elicit sexual pleasure and trigger or enhance sexual arousal when appropriately stimulated. The discovery of other forms of physical intimacy that move away from the traditional scripts of phallo-centric male sexuality (Earle et al., 2020)(Giurleo et al., 2022)(Ostrander, 2009)(Burns et al., 2008) could improve sexual pleasure. The stimulation of hypersensitive regions in the skin areas corresponding to the lesion level and above has the potential to represent one of the strategies to compensate the lack of sensitivity of the genital-sexual organs (Hohmann, 1972)(Bach-y-Rita, 1999)(Elliott, 2002)(Anderson et al., 2007)(Lopez et al., 2008)(Alexander & Marson, 2018). But again, these data are scares and limited to few testimonials.
The aim of the present research program is to identify, define and characterize erogenous zones in men with complete SCI in the absence of sensitivity of the genitals.
The study design is a qualitative observational study, and the consolidated criteria for reporting qualitative research (COREQ) will be followed (Tong et al., 2007). A minimum of fourteen semi-structured interviews with men with a complete SCI followed in a neuro-urology department will be conducted with the recruitment stopped once data saturation is achieved.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Garches, France, 92380
- Hôpital Raymond Poincaré
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Men
- Complete spinal cord injury
- Heterosexual
- Sexual activity prior to the injury
Exclusion Criteria:
- Syringomyelia
- Other neurological condition
- No sexual activity since the injury
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Caracterization of the erogenous zones
Time Frame: At the time of the interview (Baseline)
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Semi structured interviews to identifie the phenomenology behind the erogenous zones
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At the time of the interview (Baseline)
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Localization of the erogenous zones
Time Frame: At the time of the interview (Baseline)
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Body map chart
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At the time of the interview (Baseline)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.
- Bach-y-Rita P, W Kercel S. Sensory substitution and the human-machine interface. Trends Cogn Sci. 2003 Dec;7(12):541-6. doi: 10.1016/j.tics.2003.10.013.
- Chochina L, Naudet F, Chehensse C, Manunta A, Damphousse M, Bonan I, Giuliano F. Intracavernous Injections in Spinal Cord Injured Men With Erectile Dysfunction, a Systematic Review and Meta-Analysis. Sex Med Rev. 2016 Jul;4(3):257-269. doi: 10.1016/j.sxmr.2016.02.005. Epub 2016 Mar 29.
- Anderson KD, Borisoff JF, Johnson RD, Stiens SA, Elliott SL. Long-term effects of spinal cord injury on sexual function in men: implications for neuroplasticity. Spinal Cord. 2007 May;45(5):338-48. doi: 10.1038/sj.sc.3101978. Epub 2006 Oct 10.
- Alexander MS, Marson L. The neurologic control of arousal and orgasm with specific attention to spinal cord lesions: Integrating preclinical and clinical sciences. Auton Neurosci. 2018 Jan;209:90-99. doi: 10.1016/j.autneu.2017.01.005. Epub 2017 Jan 25.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QualiEroSCI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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