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Bilateral Comparison of Unilateral Sacral Neuromodulation Test Stimulation in the Treatment of Neurogenic Bladder

NCT07505940 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-04-01

No results posted yet for this study

Summary

Neurogenic bladder (NB) is a general term for a series of lower urinary tract symptoms and complications caused by bladder and/or urethral dysfunction caused by nervous system lesions. Neurogenic bladder brings physical and psychological pain to patients, affects interpersonal relationships, and seriously reduces the quality of life of patients.

Sacral neuromodulation (SNM) is an effective method for the treatment of refractory lower urinary tract dysfunction. A previous study analyzed bilateral peripheral nerve evaluation (PNE) in 62 patients with idiopathic and neurogenic bladder. The results of this clinical study showed that 51.6% of the patients (32 cases) achieved symptomatic improvement. Although a prospective controlled study was not performed, the authors suggest that bilateral treatment may improve symptoms in patients with idiopathic and neurogenic bladder compared with unilateral treatment, compared with remission rates in other previous clinical studies.

At present, there are few reports on the application of bilateral sacral neuromodulation stimulation in the treatment of voiding dysfunction, and it is still controversial whether the efficacy of bilateral stimulation is better than unilateral stimulation. Therefore, we intend to conduct a prospective, randomized controlled trial to evaluate the efficacy and safety of bilateral sacral neuromodulation test stimulation in the treatment of neurogenic lower urinary tract dysfunction.

Conditions

  • Neurogenic Bladder

Interventions

DEVICE

bilateral sacral nerve stimulation (BNS)

Participants underwent bilateral sacral nerve stimulation (BNS) and were randomly assigned to either group A or group B (1:1). In group A, unilateral stimulation was performed followed by bilateral stimulation, and in group B, bilateral stimulation was performed followed by unilateral stimulation.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • Lipeng Chen, Doctor · Qilu Hospital of Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-03-01
Completion
2027-03-01

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 NCT07505940 on ClinicalTrials.gov