NCT06908850

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 3, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2026

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

March 20, 2025

Last Update Submit

March 27, 2025

Conditions

Keywords

SexualityErogenous zonesMenSemi-structured interviews

Outcome Measures

Primary Outcomes (2)

  • Caracterization of the erogenous zones

    Semi structured interviews to identifie the phenomenology behind the erogenous zones

    At the time of the interview (Baseline)

  • Localization of the erogenous zones

    Body map chart

    At the time of the interview (Baseline)

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

heterosexual adult men with a complete spinal cord injury

You may qualify if:

  • Men
  • Complete spinal cord injury
  • Heterosexual
  • Sexual activity prior to the injury

You may not qualify if:

  • Syringomyelia
  • Other neurological condition
  • No sexual activity since the injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Raymond Poincaré

Garches, 92380, France

Location

Related Publications (5)

  • 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.

    PMID: 27871959BACKGROUND
  • 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.

    PMID: 14643370BACKGROUND
  • 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.

    PMID: 17016492BACKGROUND
  • 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.

    PMID: 15672628BACKGROUND
  • 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.

    PMID: 28222972BACKGROUND

MeSH Terms

Conditions

Spinal Cord InjuriesSexualityMultiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesSexual BehaviorBehaviorMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD student

Study Record Dates

First Submitted

March 20, 2025

First Posted

April 3, 2025

Study Start

March 17, 2025

Primary Completion

December 31, 2025

Study Completion

March 17, 2026

Last Updated

April 3, 2025

Record last verified: 2025-03

Locations