Sexual Function AbnormalNCT07093827
A Prospective Cohort Study on the Effect of Spinal Spinal Cord Injury on Sexual Function in Male Patients
An observational study of Sexual Function Abnormal and Spinal Cord Injuries (SCI), run by Peking University Third Hospital at 1 site in China.
Trial summary
1. Background and Rationale Spinal cord injury (SCI) represents a devastating neurological condition with multidimensional consequences. While motor and sensory deficits are well-characterized, sexual dysfunction remains understudied despite its profound impact on quality of life. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Sexual Function Abnormal, Spinal Cord Injuries (SCI)
- What is being tested?
- Posterior decompression surgery, unilateral open-door laminoplasty and Posterior lumbar discectomy with fusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2030
- How long will I take part?
- 8 Years
- 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 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: A multicenter-center prospective cohort analysis of patients with pre-specified diseases treated between 2020 and 2030.
Who may be able to join
- Biological males aged 18-60 years
- Married or sexually active prior to injury
- Diagnosed with pre-specified diseases
- American Spinal Injury Association (ASIA) Impairment Scale grade B-D at admission
Who cannot join
- Post-traumatic respiratory failure requiring mechanical ventilation
- History of prior spinal procedures or traumatic cord injuries
- Incomplete clinical/radiological documentation
- Insufficient follow-up duration (<24 months post-intervention)
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
- Background and Rationale Spinal cord injury (SCI) represents a devastating neurological condition with multidimensional consequences. While motor and sensory deficits are well-characterized, sexual dysfunction remains understudied despite its profound impact on quality of life. Current literature exhibits three critical gaps: (1) Limited longitudinal data on the temporal evolution of sexual dysfunction post-SCI, (2) Inadequate differentiation between psychogenic vs. neurogenic mechanisms in male patients, and (3) Heterogeneous outcome measures hindering cross-study comparisons。 This investigation builds upon pilot findings from our institution's SCI registry, where a large proportion of male participants reported clinically significant sexual impairment within 24 months post-injury. By employing standardized neuro-urological assessments alongside validated psychometric tools, this study aims to dissect the complex interplay between neurological lesion characteristics, endocrine profiles, and psychosocial adaptation processes.
- Study Objectives Primary Objective To quantify the prevalence and severity trajectories of sexual dysfunction in males with SCI post-injury. Secondary Objectives To correlate lesion level with specific sexual function domains To identify predictors of sexual health recovery using multivariate regression modeling To establish normative data for the sexual function in SCI populations
- Methodology
3.1 Study Design
Read more
Prospective observational cohort with three nested substudies:
Substudy A: Longitudinal biomechanical assessments Substudy B: Endocrine profiling Substudy C: Qualitative interviews exploring coping mechanisms
3.2 Participant Selection
Inclusion Criteria:
Males aged 18-60 years SCI confirmed by raiological methods or clinical symptoms Willing to participate in long-term follow-up
Exclusion Criteria:
Pre-existing sexual dysfunction History of prior surgical procedures Active psychiatric comorbidities 3.3 Data Collection Timeline Timepoint Assessments Baseline Neurological function, sexual function, raiological outcome 3-month Neurological function, sexual function, raiological outcome 12-month Neurological function, sexual function, raiological outcome 24-month Neurological function, sexual function, raiological outcome 36-month Neurological function, sexual function, raiological outcome 48-month Neurological function, sexual function, raiological outcome 60-month Neurological function, sexual function, raiological outcome
Read the detailed description
Spinal cord injury (SCI) induces complex pathophysiological alterations extending beyond motor-sensory impairments, with sexual dysfunction emerging as a clinically significant yet insufficiently characterized sequela. This investigation specifically targets three critical knowledge gaps in SCI-related sexual dysfunction: First, regarding neurogenic versus psychogenic differentiation, supraspinal lesions manifest through autonomic dysreflexia-mediated hemodynamic alterations in genital perfusion, while psychological comorbidities predominantly modulate libido and arousal domains. Second, concerning temporal progression dynamics, our institutional pilot data demonstrated 68% of male SCI patients developed clinically significant sexual impairment within 24 months post-injury, though precise trajectory patterns remain uncharacterized. Third, from a biomarker integration perspective, this study will employ cortisol/DHEA-S ratio analysis combined with nocturnal penile tumescence (NPT) monitoring to objectively delineate the endocrine-neurological crosstalk underlying post-SCI sexual dysfunction pathophysiology.
This study employs a robust methodological framework comprising a primary prospective observational cohort (N=180), stratified by both anatomical lesion level and neurological impairment severity. The research architecture incorporates three integrated substudies utilizing advanced multimodal assessment protocols: Substudy A applies penile duplex ultrasonography (PDU), coupled with Rigiscan® technology, International Index of Erectile Function-5 (IIEF-5) and the Premature Ejaculation Diagnostic Tool (PEDT) to quantitatively evaluate sexual parameters; Substudy B conducts high-sensitivity LC-MS/MS serum assays (testosterone, prolactin, SHBG) to systematically characterize hypothalamic-pituitary-adrenal axis dysregulation patterns post-SCI; while Substudy C employs grounded theory methodology to analyze semi-structured interviews, establishing an evidence-based model of psychosocial coping strategy efficacy validated through the International Spinal Cord Injury Male Sexual Function (ISCI-MSF) Basic Data Set and the ICIQ-ADPHS instrument. This tripartite approach ensures comprehensive mechanistic investigation across biomechanical, endocrine, and psychosocial dimensions of post-SCI sexual dysfunction.
The study implements a comprehensive data acquisition protocol employing validated quantitative metrics across multiple domains. Longitudinal data collection occurs at predetermined intervals throughout the 60-month study period. For analytical rigor, we employ group-based trajectory modeling (GBTM) to characterize IIEF score evolution, LASSO-penalized Cox regression for time-to-recovery analysis, and partial least squares path modeling (PLS-PM) to examine mechanistic relationships between lesion level and autonomic function, endocrine profiles and arousal metrics, and depression (PHQ-9) and desire domains. Normative data development utilizes kernel density estimation to establish age-stratified IIEF reference curves, while minimum detectable change (MDC) is determined through anchor-based methods incorporating the PGIC scale, ensuring clinically meaningful interpretation of results.
This investigation incorporates several cutting-edge technical innovations to enhance methodological rigor and analytical precision: standardized biobanking procedures maintain serum aliquots to facilitate future omics-based investigations; and advanced convolutional neural networks (CNNs) automate penile duplex ultrasonography (PDU) waveform analysis to ensure objective, reproducible measurements. To maintain the highest standards of data quality, we implement robust quality assurance protocols including centralized blinding procedures for IIEF scoring (inter-rater reliability κ>0.85), multiple imputation by chained equations (MICE) to address missing data, and quarterly phantom testing of Rigiscan® equipment to verify measurement accuracy (maintaining <5% error tolerance). These integrated technological and methodological safeguards ensure the collection of high-fidelity data while enabling novel multidimensional analyses of post-SCI sexual dysfunction pathophysiology.
- Being tested
- Posterior decompression surgery, unilateral open-door laminoplasty, Posterior lumbar discectomy with fusion, Surgical resection of spinal tumors, Conservative management of ankylosing spondylitis
- Medical subject headings
- Sexual Dysfunction, Physiological, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior decompression surgeryProcedure or surgery
Posterior decompression for thoracolumbar fractures involves a midline incision and subperiosteal exposure of the posterior spinal elements, followed by laminectomy or laminotomy to relieve neural compression. Pedicle screw-rod instrumentation is then applied above and below the fractured level under fluoroscopic guidance to restore stability, often supplemented by posterolateral fusion using bone graft. The procedure concludes with layered wound closure, providing direct neural decompression, rigid fixation for early mobilization, and reduced morbidity compared to anterior approaches in select cases. This technique is indicated for unstable fractures (e.g., AO Type B/C) or neurological deficits with posterior canal compromise, with variations based on fracture severity and surgical judgment.
unilateral open-door laminoplastyProcedure or surgery
Posterior cervical expansive open-door laminoplasty (also known as unilateral open-door laminoplasty) is a surgical technique used to decompress the spinal cord in cervical myelopathy or spinal cord injury. The procedure involves a midline posterior cervical incision, followed by exposure of the laminae. A high-speed burr is used to create a hinged trough on one side (preserving the inner cortex) and a complete trough on the contralateral side, allowing the lamina to be gently elevated like an opening door. The opened lamina is then stabilized using sutures, miniplates, or spacers to maintain the expanded canal diameter. This approach effectively increases spinal canal space while preserving posterior elements, reducing cord compression while minimizing instability risks compared to laminectomy. It is particularly indicated for multilevel cervical stenosis with preserved cervical alignment.
Posterior lumbar discectomy with fusionProcedure or surgery
Posterior lumbar discectomy with fusion (PLDF) is a standard surgical treatment for lumbar disc herniation with instability or recurrent symptoms. The procedure involves a midline posterior approach to expose the affected vertebral level, followed by laminotomy or partial laminectomy to access the neural elements. The herniated disc material is carefully removed to decompress the nerve roots, after which pedicle screws and rods are inserted for segmental stabilization. Interbody fusion (via posterior lumbar interbody fusion [PLIF] or transforaminal lumbar interbody fusion [TLIF]) is often performed by placing a bone graft or cage in the disc space to promote bony union. The combination of neural decompression, rigid instrumentation, and interbody fusion aims to relieve radicular pain while restoring spinal stability and alignment.
Surgical resection of spinal tumorsProcedure or surgery
Surgical resection of spinal tumors involves a tailored approach based on tumor location, type (primary/metastatic), and spinal stability. For posteriorly accessible lesions, a midline incision exposes the affected vertebrae, followed by laminectomy to access the epidural space and decompress neural elements. Tumor resection is performed using meticulous dissection, with intraoperative neuromonitoring to minimize neurological risk. In cases requiring vertebral body involvement, a posterolateral (costotransversectomy) or combined anterior-posterior approach may be used for en bloc or piecemeal excision. Reconstruction typically involves spinal instrumentation (pedicle screws/rods) and structural support (cages/allografts) to restore stability. The goal is maximal safe resection while preserving neurological function, often supplemented by adjuvant therapies (radiation/chemotherapy) for malignant tumors.
Conservative management of ankylosing spondylitisDrug
Conservative management of ankylosing spondylitis (AS) focuses on symptom relief, functional preservation, and slowing disease progression through a multidisciplinary approach. First-line pharmacotherapy includes NSAIDs (e.g., celecoxib) for pain and inflammation control, supplemented by TNF-α inhibitors (e.g., adalimumab) or IL-17 inhibitors for refractory cases. Physical therapy emphasizes daily spinal extension exercises, postural training, and deep breathing to maintain mobility and prevent kyphotic deformity. Patient education on ergonomic adjustments (sleeping positions, workplace modifications) and low-impact aerobic exercise (swimming, yoga) is integral. Smoking cessation is strongly advocated due to its association with worse outcomes. Regular monitoring with inflammatory markers (CRP/ESR) and imaging (MRI for early sacroiliitis) guides therapeutic adjustments, while comorbidities (uveitis, osteoporosis) require coordinated care.
anterior cervical discectomy/fusionProcedure or surgery
Surgical management of cervical spondylotic myelopathy (CSM) aims to decompress the spinal cord and stabilize the spine, with the approach tailored to pathology and spinal alignment. For multilevel anterior compression, anterior cervical discectomy/fusion (ACDF) or corpectomy with plating is preferred, utilizing structural grafts or cages to restore lordosis. Posterior approaches (laminoplasty or laminectomy with fusion) are indicated for multilevel stenosis with preserved cervical curvature, employing lateral mass or pedicle screws for fixation. Hybrid strategies (e.g., ACDF combined with laminoplasty) address complex cases. Intraoperative neuromonitoring (SSEPs/MEPs) minimizes neurological risks, while emerging techniques like cervical disc arthroplasty are considered in select patients to preserve motion. Surgical timing is critical, with earlier intervention correlating to better neurological recovery in progressive myelopathy.
anterior cervical corpectomy/fusionProcedure or surgery
Surgical management of cervical spondylotic myelopathy (CSM) aims to decompress the spinal cord and stabilize the spine, with the approach tailored to pathology and spinal alignment. For multilevel anterior compression, anterior cervical discectomy/fusion (ACDF) or corpectomy with plating is preferred, utilizing structural grafts or cages to restore lordosis. Posterior approaches (laminoplasty or laminectomy with fusion) are indicated for multilevel stenosis with preserved cervical curvature, employing lateral mass or pedicle screws for fixation. Hybrid strategies (e.g., ACDF combined with laminoplasty) address complex cases. Intraoperative neuromonitoring (SSEPs/MEPs) minimizes neurological risks, while emerging techniques like cervical disc arthroplasty are considered in select patients to preserve motion. Surgical timing is critical, with earlier intervention correlating to better neurological recovery in progressive myelopathy.
Conservative management of lumbar spinal stenosisDrug
Conservative management of lumbar spinal stenosis (LSS) focuses on symptom alleviation and functional improvement through a multimodal approach. First-line interventions include NSAIDs or acetaminophen for neurogenic claudication pain, with consideration of epidural steroid injections for refractory radicular symptoms. Supervised physical therapy emphasizes flexion-based exercises, core stabilization, and aquatic therapy to reduce mechanical stress on neural structures. Activity modification strategies (e.g., avoiding prolonged standing) combined with assistive devices (walking frames) improve mobility. Adjuvant therapies such as gabapentinoids may be trialed for neuropathic pain, while cardiovascular conditioning (stationary cycling) counters deconditioning. Patient education on weight management and posture optimization is integral, with surgical evaluation reserved for progressive neurological deficits or failure of 3-6 months structured conservative care.
decompression surgery for caudal plexus disorderProcedure or surgery
Surgical intervention for caudal plexus disorders is indicated in cases of structural compression, trauma, or refractory symptoms unresponsive to conservative measures. The approach involves meticulous exposure of the lumbosacral plexus through a retroperitoneal or transabdominal route, depending on lesion location. For compressive pathologies, microsurgical decompression with intraoperative neurophysiological monitoring (IONM) is performed to minimize iatrogenic injury. In traumatic avulsions or sharp injuries, direct nerve repair, grafting, or neurolysis may be attempted to restore function. For chronic pain syndromes, dorsal root entry zone (DREZ) ablation or nerve decompression may be considered. Surgical success depends on etiology, timing of intervention, and extent of neural damage, with optimal outcomes achieved in early decompression of compressive lesions or precise repair of focal injuries.
| Study group | Role | What they receive |
|---|---|---|
| thoracolumber fracture | Not described Receives: Procedure: Posterior decompression surgery | |
| Cervical spinal cord injury without fracture or dislocation | Not described Receives: Procedure: unilateral open-door laminoplasty | |
| Lumbar disc herniation | Not described Receives: Procedure: Posterior lumbar discectomy with fusion | |
| Spine tumors | Not described Receives: Procedure: Surgical resection of spinal tumors | |
| Ankylosing spondylitis | Not described Receives: Drug: Conservative management of ankylosing spondylitis; Procedure: decompression surgery for caudal plexus disorder | |
| Cervical spondylosis of the spinal cord | Not described Receives: Procedure: anterior cervical discectomy/fusion; Procedure: anterior cervical corpectomy/fusion | |
| Lumbar stenosis | Not described Receives: Drug: Conservative management of lumbar spinal stenosis | |
| Caudal plexus disorder | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Premature Ejaculation Diagnostic Tool (PEDT)
Premature ejaculation status was determined using the PEDT, classified as confirmed (≥11, Grade 1), borderline (9-10, Grade 2), or absent (≤8, Grade 3), with lower scores reflecting improved ejaculatory control.
Measured: baseline (before injury), immediately after injury, 1, 3, 6, 12, 24, 36, 60 months after surgery
International Index of Erectile Function-5 (IIEF-5)
Erectile function was quantitatively assessed via the IIEF-5, categorized into ordinal grades: severe dysfunction (1-7, Grade 1), moderate (8-11, Grade 2), mild (12-21, Grade 3), and normal (22-25, Grade 4), where higher scores denoted preserved erectile capacity.
Measured: baseline (before injury), immediately after injury, 1, 3, 6, 12, 24, 36, 60 months after surgery
American Spinal Injury Association (ASIA) Impairment Scale
Neurological and functional outcomes were prospectively assessed through standardized outpatient evaluations and telemedicine follow-ups. Sensory and motor functions were classified using the ASIA Impairment Scale, the internationally recognized benchmark for spinal cord injury severity.
Measured: baseline (before injury), immediately after injury, 1, 3, 6, 12, 24, 36, 60 months after surgery
Secondary outcomes (5)
the International Spinal Cord Injury Male Sexual Function (ISCI-MSF) Basic Data Set
The ISCI-MSF Basic Data Set prospectively captured psychosexual parameters, including sexual communication willingness, reflexogenic/psychogenic erection capacity, and orgasmic function.
Measured: immediately after injury, 1, 3, 6, 12, 24, 36, 60 months after surgery
Torg-Pavlov ratio
The TPR-a validated radiographic marker for developmental spinal canal stenosis-was derived by dividing mid-sagittal spinal canal diameter by corresponding vertebral body diameter on neutral lateral radiographs, measured via calibrated digital calipers.
Measured: immediately after injury, 1, 12, 24, 36, 60 months after surgery
preoperative high cord signals (HCS) in MRI T2WIs
Intramedullary hyperintensity was quantified using mid-sagittal T2-weighted MRI: circular regions of interest (ROIs, 0.05 cm²) were delineated at sites of maximal cord hyperintensity, with reference ROIs (0.3 cm²) sampled at C7-T1 (Figure 2). The SIR was calculated as mean pathological ROI intensity divided by mean reference ROI intensity; SIR ≥1.32 defined HCS, indicative of edema, hemorrhage or liquefaction.
Measured: immediately after injury, 1, 12, 24, 36, 60 months after surgery
the rate of spinal cord compression
Spinal cord compression rate was computed from axial T2-MRI measurements as [(uncompressed anteroposterior spinal cord diameter - maximal compressed diameter)/uncompressed diameter] × 100% (Figure 3), with ≥20% denoting significant compression.
Measured: immediately after injury
number of levels fused
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Jan 2020
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Function AbnormalStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,600 participants (estimated)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Luohe Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093827
- Sponsor's protocol ID
- PekingUTH LXZ-SF
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on the Effect of Spinal Spinal Cord Injury on Sexual Function in Male Patients
- ClinicalTrials.gov ID
- NCT07093827
- Acronym / sponsor ID
- PekingUTH LXZ-SF
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Luohe Central Hospital
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 Jul 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.
- Background and Rationale Spinal cord injury (SCI) represents a devastating neurological condition with multidimensional consequences. While motor and sensory deficits are well-characterized, sexual dysfunction remains understudied despite its profound impact on quality of life. Current literature exhibits three critical gaps: (1) Limited longitudinal data on the temporal evolution of sexual dysfunction post-SCI, (2) Inadequate differentiation between psychogenic vs. neurogenic mechanisms in male patients, and (3) Heterogeneous outcome measures hindering cross-study comparisons。 This investigation builds upon pilot findings from our institution's SCI registry, where a large proportion of male participants reported clinically significant sexual impairment within 24 months post-injury. By employing standardized neuro-urological assessments alongside validated psychometric tools, this study aims to dissect the complex interplay between neurological lesion characteristics, endocrine profiles, and psychosocial adaptation processes.
- Study Objectives Primary Objective To quantify the prevalence and severity trajectories of sexual dysfunction in males with SCI post-injury. Secondary Objectives To correlate lesion level with specific sexual function domains To identify predictors of sexual health recovery using multivariate regression modeling To establish normative data for the sexual function in SCI populations
- Methodology
3.1 Study Design
Prospective observational cohort with three nested substudies:
Substudy A: Longitudinal biomechanical assessments Substudy B: Endocrine profiling Substudy C: Qualitative interviews exploring coping mechanisms
3.2 Participant Selection
Inclusion Criteria:
Males aged 18-60 years SCI confirmed by raiological methods or clinical symptoms Willing to participate in long-term follow-up
Exclusion Criteria:
Pre-existing sexual dysfunction History of prior surgical procedures Active psychiatric comorbidities 3.3 Data Collection Timeline Timepoint Assessments Baseline Neurological function, sexual function, raiological outcome 3-month Neurological function, sexual function, raiological outcome 12-month Neurological function, sexual function, raiological outcome 24-month Neurological function, sexual function, raiological outcome 36-month Neurological function, sexual function, raiological outcome 48-month Neurological function, sexual function, raiological outcome 60-month Neurological function, sexual function, raiological outcome
Detailed description
Spinal cord injury (SCI) induces complex pathophysiological alterations extending beyond motor-sensory impairments, with sexual dysfunction emerging as a clinically significant yet insufficiently characterized sequela. This investigation specifically targets three critical knowledge gaps in SCI-related sexual dysfunction: First, regarding neurogenic versus psychogenic differentiation, supraspinal lesions manifest through autonomic dysreflexia-mediated hemodynamic alterations in genital perfusion, while psychological comorbidities predominantly modulate libido and arousal domains. Second, concerning temporal progression dynamics, our institutional pilot data demonstrated 68% of male SCI patients developed clinically significant sexual impairment within 24 months post-injury, though precise trajectory patterns remain uncharacterized. Third, from a biomarker integration perspective, this study will employ cortisol/DHEA-S ratio analysis combined with nocturnal penile tumescence (NPT) monitoring to objectively delineate the endocrine-neurological crosstalk underlying post-SCI sexual dysfunction pathophysiology.
This study employs a robust methodological framework comprising a primary prospective observational cohort (N=180), stratified by both anatomical lesion level and neurological impairment severity. The research architecture incorporates three integrated substudies utilizing advanced multimodal assessment protocols: Substudy A applies penile duplex ultrasonography (PDU), coupled with Rigiscan® technology, International Index of Erectile Function-5 (IIEF-5) and the Premature Ejaculation Diagnostic Tool (PEDT) to quantitatively evaluate sexual parameters; Substudy B conducts high-sensitivity LC-MS/MS serum assays (testosterone, prolactin, SHBG) to systematically characterize hypothalamic-pituitary-adrenal axis dysregulation patterns post-SCI; while Substudy C employs grounded theory methodology to analyze semi-structured interviews, establishing an evidence-based model of psychosocial coping strategy efficacy validated through the International Spinal Cord Injury Male Sexual Function (ISCI-MSF) Basic Data Set and the ICIQ-ADPHS instrument. This tripartite approach ensures comprehensive mechanistic investigation across biomechanical, endocrine, and psychosocial dimensions of post-SCI sexual dysfunction.
The study implements a comprehensive data acquisition protocol employing validated quantitative metrics across multiple domains. Longitudinal data collection occurs at predetermined intervals throughout the 60-month study period. For analytical rigor, we employ group-based trajectory modeling (GBTM) to characterize IIEF score evolution, LASSO-penalized Cox regression for time-to-recovery analysis, and partial least squares path modeling (PLS-PM) to examine mechanistic relationships between lesion level and autonomic function, endocrine profiles and arousal metrics, and depression (PHQ-9) and desire domains. Normative data development utilizes kernel density estimation to establish age-stratified IIEF reference curves, while minimum detectable change (MDC) is determined through anchor-based methods incorporating the PGIC scale, ensuring clinically meaningful interpretation of results.
This investigation incorporates several cutting-edge technical innovations to enhance methodological rigor and analytical precision: standardized biobanking procedures maintain serum aliquots to facilitate future omics-based investigations; and advanced convolutional neural networks (CNNs) automate penile duplex ultrasonography (PDU) waveform analysis to ensure objective, reproducible measurements. To maintain the highest standards of data quality, we implement robust quality assurance protocols including centralized blinding procedures for IIEF scoring (inter-rater reliability κ>0.85), multiple imputation by chained equations (MICE) to address missing data, and quarterly phantom testing of Rigiscan® equipment to verify measurement accuracy (maintaining <5% error tolerance). These integrated technological and methodological safeguards ensure the collection of high-fidelity data while enabling novel multidimensional analyses of post-SCI sexual dysfunction pathophysiology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Years
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| thoracolumber fracture | – | Procedure: Posterior decompression surgery |
| Cervical spinal cord injury without fracture or dislocation | – | Procedure: unilateral open-door laminoplasty |
| Lumbar disc herniation | – | Procedure: Posterior lumbar discectomy with fusion |
| Spine tumors | – | Procedure: Surgical resection of spinal tumors |
| Ankylosing spondylitis | – | Drug: Conservative management of ankylosing spondylitis, Procedure: decompression surgery for caudal plexus disorder |
| Cervical spondylosis of the spinal cord | – | Procedure: anterior cervical discectomy/fusion, Procedure: anterior cervical corpectomy/fusion |
| Lumbar stenosis | – | Drug: Conservative management of lumbar spinal stenosis |
| Caudal plexus disorder | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A multicenter-center prospective cohort analysis of patients with pre-specified diseases treated between 2020 and 2030.
Key inclusion criteria (4 listed)
- Biological males aged 18-60 years
- Married or sexually active prior to injury
- Diagnosed with pre-specified diseases
- American Spinal Injury Association (ASIA) Impairment Scale grade B-D at admission
Key exclusion criteria (4 listed)
- Post-traumatic respiratory failure requiring mechanical ventilation
- History of prior spinal procedures or traumatic cord injuries
- Incomplete clinical/radiological documentation
- Insufficient follow-up duration (<24 months post-intervention)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior decompression surgeryPosterior decompression for thoracolumbar fractures involves a midline incision and subperiosteal exposure of the posterior spinal elements, followed by laminectomy or laminotomy to relieve neural compression. Pedicle screw-rod instrumentation is then applied above and below the fractured level under fluoroscopic guidance to restore stability, often supplemented by posterolateral fusion using bone graft. The procedure concludes with layered wound closure, providing direct neural decompression, rigid fixation for early mobilization, and reduced morbidity compared to anterior approaches in select cases. This technique is indicated for unstable fractures (e.g., AO Type B/C) or neurological deficits with posterior canal compromise, with variations based on fracture severity and surgical judgment. | Procedure or surgery | thoracolumber fracture |
| unilateral open-door laminoplastyPosterior cervical expansive open-door laminoplasty (also known as unilateral open-door laminoplasty) is a surgical technique used to decompress the spinal cord in cervical myelopathy or spinal cord injury. The procedure involves a midline posterior cervical incision, followed by exposure of the laminae. A high-speed burr is used to create a hinged trough on one side (preserving the inner cortex) and a complete trough on the contralateral side, allowing the lamina to be gently elevated like an opening door. The opened lamina is then stabilized using sutures, miniplates, or spacers to maintain the expanded canal diameter. This approach effectively increases spinal canal space while preserving posterior elements, reducing cord compression while minimizing instability risks compared to laminectomy. It is particularly indicated for multilevel cervical stenosis with preserved cervical alignment. | Procedure or surgery | Cervical spinal cord injury without fracture or dislocation |
| Posterior lumbar discectomy with fusionPosterior lumbar discectomy with fusion (PLDF) is a standard surgical treatment for lumbar disc herniation with instability or recurrent symptoms. The procedure involves a midline posterior approach to expose the affected vertebral level, followed by laminotomy or partial laminectomy to access the neural elements. The herniated disc material is carefully removed to decompress the nerve roots, after which pedicle screws and rods are inserted for segmental stabilization. Interbody fusion (via posterior lumbar interbody fusion [PLIF] or transforaminal lumbar interbody fusion [TLIF]) is often performed by placing a bone graft or cage in the disc space to promote bony union. The combination of neural decompression, rigid instrumentation, and interbody fusion aims to relieve radicular pain while restoring spinal stability and alignment. | Procedure or surgery | Lumbar disc herniation |
| Surgical resection of spinal tumorsSurgical resection of spinal tumors involves a tailored approach based on tumor location, type (primary/metastatic), and spinal stability. For posteriorly accessible lesions, a midline incision exposes the affected vertebrae, followed by laminectomy to access the epidural space and decompress neural elements. Tumor resection is performed using meticulous dissection, with intraoperative neuromonitoring to minimize neurological risk. In cases requiring vertebral body involvement, a posterolateral (costotransversectomy) or combined anterior-posterior approach may be used for en bloc or piecemeal excision. Reconstruction typically involves spinal instrumentation (pedicle screws/rods) and structural support (cages/allografts) to restore stability. The goal is maximal safe resection while preserving neurological function, often supplemented by adjuvant therapies (radiation/chemotherapy) for malignant tumors. | Procedure or surgery | Spine tumors |
| Conservative management of ankylosing spondylitisConservative management of ankylosing spondylitis (AS) focuses on symptom relief, functional preservation, and slowing disease progression through a multidisciplinary approach. First-line pharmacotherapy includes NSAIDs (e.g., celecoxib) for pain and inflammation control, supplemented by TNF-α inhibitors (e.g., adalimumab) or IL-17 inhibitors for refractory cases. Physical therapy emphasizes daily spinal extension exercises, postural training, and deep breathing to maintain mobility and prevent kyphotic deformity. Patient education on ergonomic adjustments (sleeping positions, workplace modifications) and low-impact aerobic exercise (swimming, yoga) is integral. Smoking cessation is strongly advocated due to its association with worse outcomes. Regular monitoring with inflammatory markers (CRP/ESR) and imaging (MRI for early sacroiliitis) guides therapeutic adjustments, while comorbidities (uveitis, osteoporosis) require coordinated care. | Drug | Ankylosing spondylitis |
| anterior cervical discectomy/fusionSurgical management of cervical spondylotic myelopathy (CSM) aims to decompress the spinal cord and stabilize the spine, with the approach tailored to pathology and spinal alignment. For multilevel anterior compression, anterior cervical discectomy/fusion (ACDF) or corpectomy with plating is preferred, utilizing structural grafts or cages to restore lordosis. Posterior approaches (laminoplasty or laminectomy with fusion) are indicated for multilevel stenosis with preserved cervical curvature, employing lateral mass or pedicle screws for fixation. Hybrid strategies (e.g., ACDF combined with laminoplasty) address complex cases. Intraoperative neuromonitoring (SSEPs/MEPs) minimizes neurological risks, while emerging techniques like cervical disc arthroplasty are considered in select patients to preserve motion. Surgical timing is critical, with earlier intervention correlating to better neurological recovery in progressive myelopathy. | Procedure or surgery | Cervical spondylosis of the spinal cord |
| anterior cervical corpectomy/fusionSurgical management of cervical spondylotic myelopathy (CSM) aims to decompress the spinal cord and stabilize the spine, with the approach tailored to pathology and spinal alignment. For multilevel anterior compression, anterior cervical discectomy/fusion (ACDF) or corpectomy with plating is preferred, utilizing structural grafts or cages to restore lordosis. Posterior approaches (laminoplasty or laminectomy with fusion) are indicated for multilevel stenosis with preserved cervical curvature, employing lateral mass or pedicle screws for fixation. Hybrid strategies (e.g., ACDF combined with laminoplasty) address complex cases. Intraoperative neuromonitoring (SSEPs/MEPs) minimizes neurological risks, while emerging techniques like cervical disc arthroplasty are considered in select patients to preserve motion. Surgical timing is critical, with earlier intervention correlating to better neurological recovery in progressive myelopathy. | Procedure or surgery | Cervical spondylosis of the spinal cord |
| Conservative management of lumbar spinal stenosisConservative management of lumbar spinal stenosis (LSS) focuses on symptom alleviation and functional improvement through a multimodal approach. First-line interventions include NSAIDs or acetaminophen for neurogenic claudication pain, with consideration of epidural steroid injections for refractory radicular symptoms. Supervised physical therapy emphasizes flexion-based exercises, core stabilization, and aquatic therapy to reduce mechanical stress on neural structures. Activity modification strategies (e.g., avoiding prolonged standing) combined with assistive devices (walking frames) improve mobility. Adjuvant therapies such as gabapentinoids may be trialed for neuropathic pain, while cardiovascular conditioning (stationary cycling) counters deconditioning. Patient education on weight management and posture optimization is integral, with surgical evaluation reserved for progressive neurological deficits or failure of 3-6 months structured conservative care. | Drug | Lumbar stenosis |
| decompression surgery for caudal plexus disorderSurgical intervention for caudal plexus disorders is indicated in cases of structural compression, trauma, or refractory symptoms unresponsive to conservative measures. The approach involves meticulous exposure of the lumbosacral plexus through a retroperitoneal or transabdominal route, depending on lesion location. For compressive pathologies, microsurgical decompression with intraoperative neurophysiological monitoring (IONM) is performed to minimize iatrogenic injury. In traumatic avulsions or sharp injuries, direct nerve repair, grafting, or neurolysis may be attempted to restore function. For chronic pain syndromes, dorsal root entry zone (DREZ) ablation or nerve decompression may be considered. Surgical success depends on etiology, timing of intervention, and extent of neural damage, with optimal outcomes achieved in early decompression of compressive lesions or precise repair of focal injuries. | Procedure or surgery | Ankylosing spondylitis |
Primary outcome
the Premature Ejaculation Diagnostic Tool (PEDT)
Time frame: baseline (before injury), immediately after injury, 1, 3, 6, 12, 24, 36, 60 months after surgery
Premature ejaculation status was determined using the PEDT, classified as confirmed (≥11, Grade 1), borderline (9-10, Grade 2), or absent (≤8, Grade 3), with lower scores reflecting improved ejaculatory control.
International Index of Erectile Function-5 (IIEF-5)
Time frame: baseline (before injury), immediately after injury, 1, 3, 6, 12, 24, 36, 60 months after surgery
Erectile function was quantitatively assessed via the IIEF-5, categorized into ordinal grades: severe dysfunction (1-7, Grade 1), moderate (8-11, Grade 2), mild (12-21, Grade 3), and normal (22-25, Grade 4), where higher scores denoted preserved erectile capacity.
American Spinal Injury Association (ASIA) Impairment Scale
Time frame: baseline (before injury), immediately after injury, 1, 3, 6, 12, 24, 36, 60 months after surgery
Neurological and functional outcomes were prospectively assessed through standardized outpatient evaluations and telemedicine follow-ups. Sensory and motor functions were classified using the ASIA Impairment Scale, the internationally recognized benchmark for spinal cord injury severity.
5 secondary outcomes
the International Spinal Cord Injury Male Sexual Function (ISCI-MSF) Basic Data Set
Time frame: immediately after injury, 1, 3, 6, 12, 24, 36, 60 months after surgery
Torg-Pavlov ratio
Time frame: immediately after injury, 1, 12, 24, 36, 60 months after surgery
preoperative high cord signals (HCS) in MRI T2WIs
Time frame: immediately after injury, 1, 12, 24, 36, 60 months after surgery
the rate of spinal cord compression
Time frame: immediately after injury
number of levels fused
Time frame: immediately after surgery
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 30 Jul 2025.
- 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. This study is not recruiting at the moment.
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 Sexual Function Abnormal and Spinal Cord Injuries (SCI), run by Peking University Third Hospital at 1 site in China.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 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 China. 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?
the Premature Ejaculation Diagnostic Tool (PEDT) (time frame: baseline (before injury), immediately after injury, 1, 3, 6, 12, 24, 36, 60 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2025.