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

This trial does not accept healthy volunteers

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 population

The subjects were patients from Qilu Hospital, Shandong University.Recruitment process for research subjects:(1) Preliminary screening of patients based on admission and exclusion criteria;(2) Promote clinical trials to potential participants;(3) The assistant shall compile and organize the basic information and intention to participate in the trial of personnel who meet the recruitment requirements, inform them of the procedures for participating in the trial, and arrange for the recruitment of candidates to participate in the trial screening;(4) Researchers will further screen the recruited subjects according to the requirements of the experimental plan, and those who meet the requirements will be assigned to the group and included in the normal experimental procedure; For those that do not meet the requirements, notify the assistant to handle subsequent matters, such as explaining the work, distributing transportation subsidies, etc

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

  • sacral neuromodulation

    Device

    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

Treatment groups

41 Participants
are divided into 1 treatment group
Group A: SNM group1 intervention

Trial outcomes

Primary outcomes

1

urodynamics

To examine function of bladder

Time frame
3,6,12 month
2

renal function

To examine function of kidney

Time frame
3,6,12 month
3

Urinary ultrasound

morphological change of urinary system

Time frame
3,6,12 month

Secondary outcomes

Other outcomes

Sponsors and contacts

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