Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 5:29 AM
Study NCT ID:
NCT06553469
Status:
RECRUITING
Last Update Posted:
2024-08-14
First Post:
2024-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury：A Prospective, Single-arm Study
Sponsor:
Qilu Hospital of Shandong University
Organization:
Study Overview
Official Title:
Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to investigate the long-term efficacy of sacral nerve modulation surgery in the treatment of neurogenic lower urinary tract dysfunction caused by incomplete spinal cord injury, as well as its preventive effect on complications of neurogenic lower urinary tract dysfunction. We will use urodynamic examination results such as maximum bladder capacity and detrusor leak point pressure, combined with renal function and urinary ultrasound results, as our evaluation indicators. Follow up evaluations will be conducted at 6 and 12 months after permanent implantation, and periodic comparisons will be made with baseline data to gain a more comprehensive understanding of the effectiveness and safety of sacral nerve regulation surgery.
Detailed Description:
Spinal cord injury is a serious type of central nervous system injury that not only causes movement disorders, but also damages the bladder, intestines, and autonomic nervous circuits related to sexual function, leading to urinary and defecation disorders. Sacral nerve modulation is a technology that applies low-frequency electric pulse to specific sacral nerve continuously to affect and regulate the function of target organs, so as to treat urgent urinary incontinence, overactivity of bladder, urinary retention, fecal incontinence and other diseases. However, there is currently no consensus on whether this technology can treat urinary and defecation dysfunction caused by spinal cord injury, and its specific mechanism still needs to be studied. Existing research shows that this technique can reduce the excitability of sphincter by inhibiting the protective reflex to treat urinary retention; Treating detrusor overactivity by inhibiting detrusor muscle activity without affecting urethral resistance and detrusor muscle contraction during urination. This study hypothesizes that sacral nerve modulation intervention after spinal cord injury can reduce bladder spasms, maintain bladder compliance, bladder capacity, and low bladder filling pressure, delay the progression of bladder fibrosis and hydronephrosis after spinal cord injury, and improve symptoms such as constipation. Based on the above evidence and hypotheses, we designed a single arm clinical trial to evaluate the effectiveness and safety of sacral nerve modulation surgery in treating urinary and defecation dysfunction after incomplete spinal cord injury, especially in preventing complications such as bladder fibrosis and hydronephrosis. We also evaluated the impact of sacral nerve modulation surgery on the quality of life of patients after spinal cord injury, as well as the improvement effect of sacral nerve modulation surgery on urinary and reproductive system related symptoms and intestinal symptoms.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: