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Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury：A Prospective, Single-arm Study

NCT06553469 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 41

Last updated 2024-08-14

No results posted yet for this study

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.

Conditions

  • Cystometry
  • Sacral Neuromodulation
  • Ultrasound

Interventions

DEVICE

sacral neuromodulation

After screening according to the inclusion and exclusion criteria, the subjects were enrolled in the study. The sacral nerve regulation treatment was divided into two phases. Phase I was the testing phase, during which the sacral nerve stimulation electrode component was implanted. After the electrode was implanted, it was tested for 2-4 weeks. According to the urine diary and scale scores, if the symptoms improved by ≥ 50%, or if the patient requested to continue with Phase II and was evaluated by the researcher as suitable for implantation, Phase II (permanent implantation phase) treatment was performed, during which the sacral nerve stimulation pulse generator component was implanted

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • Lipeng Chen, Dortor · Qilu Hospital of Shandong University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-12-01
Completion
2025-12-31
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06553469 on ClinicalTrials.gov