Spinal Cord InjuryQualiEroSCINCT06908850
The Aim of This Research is to Better Understand How Complete Spinal Cord Injury May Change Erogenous Zones in Adult Males
An observational study of Spinal Cord Injury and Spinal Cord Injury No Sensory/Motor in S4-S5, run by Fondation Garches at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Spinal Cord Injury, Spinal Cord Injury No Sensory/Motor in S4-S5
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2025to 17 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: heterosexual adult men with a complete spinal cord injury
Who may be able to join
- Men
- Complete spinal cord injury
- Heterosexual
- Sexual activity prior to the injury
Who cannot join
- Syringomyelia
- Other neurological condition
- No sexual activity since the injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Keywords
- Sexuality, Erogenous zones, Men, Semi-structured interviews
- Medical subject headings
- Spinal Cord Injuries, Sexuality, Multiple Endocrine Neoplasia Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Caracterization of the erogenous zones
Semi structured interviews to identifie the phenomenology behind the erogenous zones
Measured: At the time of the interview (Baseline)
Localization of the erogenous zones
Body map chart
Measured: At the time of the interview (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start17 Mar 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion17 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Garches
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine Streit, Fondation Garches
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908850
- Sponsor's protocol ID
- QualiEroSCI
- Acronym
- QualiEroSCI
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27871959Bach-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.
PubMed 14643370Anderson 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.
PubMed 17016492Anderson 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.
PubMed 15672628Alexander 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.
PubMed 28222972
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erogenous Zones in Adult Males After Complete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06908850
- Acronym / sponsor ID
- QualiEroSCI / QualiEroSCI
- Keywords
- Sexuality, Erogenous zones, Men, Semi-structured interviews
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fondation GarchesUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 17 Mar 2026 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- heterosexual adult men with a complete spinal cord injury
Key inclusion criteria (4 listed)
- Men
- Complete spinal cord injury
- Heterosexual
- Sexual activity prior to the injury
Key exclusion criteria (3 listed)
- Syringomyelia
- Other neurological condition
- No sexual activity since the injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Caracterization of the erogenous zones
Time frame: At the time of the interview (Baseline)
Semi structured interviews to identifie the phenomenology behind the erogenous zones
Localization of the erogenous zones
Time frame: At the time of the interview (Baseline)
Body map chart
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Background: PubMed 27871959Chochina 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.
- Background: PubMed 14643370Bach-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.
- Background: PubMed 17016492Anderson 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.
- Background: PubMed 15672628Anderson 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.
- Background: PubMed 28222972Alexander 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury and Spinal Cord Injury No Sensory/Motor in S4-S5, run by Fondation Garches at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caracterization of the erogenous zones (time frame: At the time of the interview (Baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06908850, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.