A Prospective Cohort Study on the Effect of Spinal Spinal Cord Injury on Sexual Function in Male Patients

NCT07093827 | Active Not Recruiting DMC

• 1 other identifier: PekingUTH LXZ-SF
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Background and Rationale
2. 2.Study Objectives
3. 3.Methodology

Conditions

Sexual Function Abnormal; Spinal Cord Injuries (SCI)

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  immediately after injury, 1, 3, 6, 12, 24, 36, 60 months after surgery

• Torg-Pavlov ratio

  immediately after injury, 1, 12, 24, 36, 60 months after surgery

• preoperative high cord signals (HCS) in MRI T2WIs

  immediately after injury, 1, 12, 24, 36, 60 months after surgery

• the rate of spinal cord compression

  immediately after injury

• number of levels fused

  immediately after surgery

Other Outcomes (6)

• age

  baseline

• body mass index (BMI, kg/m²)

  baseline

• time interval from injury to intervention

  immediately after surgery

Study Arms (8)

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

Interventions

Posterior decompression surgery PROCEDURE

\*\*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.\*\*

thoracolumber fracture

unilateral open-door laminoplasty PROCEDURE

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.

Cervical spinal cord injury without fracture or dislocation

Posterior lumbar discectomy with fusion PROCEDURE

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.

Lumbar disc herniation

Surgical resection of spinal tumors PROCEDURE

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.

Spine tumors

Conservative management of ankylosing spondylitis DRUG

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.

Ankylosing spondylitis

anterior cervical discectomy/fusion PROCEDURE

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.

Cervical spondylosis of the spinal cord

anterior cervical corpectomy/fusion PROCEDURE

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.

Cervical spondylosis of the spinal cord

Conservative management of lumbar spinal stenosis DRUG

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.

Lumbar stenosis

decompression surgery for caudal plexus disorder PROCEDURE

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.

Ankylosing spondylitis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A multicenter-center prospective cohort analysis of patients with pre-specified diseases treated between 2020 and 2030.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Luohe Central Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Spinal Cord Injuries

Interventions

Gene Fusion; Laminectomy

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena; Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 30, 2025
• Study Start: January 1, 2020
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 30, 2025

Record last verified: 2025-06

Locations

CN (1)