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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQilu Hospital of Shandong University

About this trial

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.

Eligibility criteria

Qualifiers

Age over 18 years old, gender not limited

Diagnosed with urinary and defecation dysfunction caused by spinal cord injury

Urodynamic examination suggests bladder dysfunction

ASIA spinal cord injury classification: B, C, or D

Disqualifiers

Other causes of lower urinary tract dysfunction cannot be ruled out, or other diseases that may lead to lower urinary tract dysfunction cannot be ruled out

Pregnant women, lactating women, women of childbearing age who plan to conceive or have no safe contraceptive measures during the study period

Patients with mental and cognitive impairments, as well as those who are unable to cooperate with the experimental process

Patients with untreated infections, coagulation disorders, malignant tumors, and other serious illnesses

Trial design

Treatments tested in this trial

  • sacral neuromodulation

Treatment groups

41 Participants
are divided into 1 treatment group