The Aim of This Research is to Better Understand How Complete Spinal Cord Injury May Change Erogenous Zones in Adult Males

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender Male
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06908850
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fondation Garches
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Spinal Cord Injury, Spinal Cord Injury No Sensory/Motor in S4-S5

Contact a Trial Team

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International Sites

Hopital Raymond Poincaré, Garches 3016675, France

Status

Address

Hopital Raymond Poincaré

Garches 3016675, , 92380

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