Efficacy of Electrical Pudendal Nerve Stimulation and Sacral in Treating Non-obstructive Neurogenic Urinary Retention

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Status: Completed

Conditions: Urinary Retention

Treatments: Procedure: sacral neuromodulation; Procedure: electrical pudendal nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06158074

2018-099

Details and patient eligibility

About

To observe the clinical effects and make a comparative study between efficacy of electrical pudendal nerve stimulation (EPNS) and sacral neuromodulation (SNM) , evaluate the advantages of EPNS in the treatment of neurogenic non-obstructive urinary retention, and provide a new method for the treatment of the disease.

Enrollment: 70 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-mechanical obstructive urinary retention occurs following relevant neurological system disorders (spinal cord injury, spina bifida，myelitis, cervical/thoracic disk disease, lesion following spinal anesthesia/spine surgery,lumbar/sacral spine intervertebral disc diseases, spinal stenosis, iatrogenic pelvic nerve lesions, sacral agenesis, peripheral neuropathy due to diabetes mellitus).
• With normal upper urinary tract function.
• Other therapies and medications potentially affecting the assessment of this therapy have been discontinued for at least two weeks before the interventional procedure.
• Patient with good compliance who is capable of cooperating with the follow-up requirements

Exclusion criteria

• Patients with any suprapontine and pontine lesions
• Pregnant or lactating women
• Individuals whose symptoms show significant improvement after pharmaceutical and adjunctive therapy
• Individuals with concurrent acute or chronic prostatitis, prostate cancer, or conditions such as bladder neck stenosis, urethral stricture, or urethral injury
• High pathological risk factors (e.g., lymph node metastasis, resection margin involvement, bulky tumors)
• Individuals with concomitant obstructive urinary retention

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

EPNS group

Experimental group

Treatment:

Procedure: electrical pudendal nerve stimulation

SNM group

Active Comparator group

Treatment:

Procedure: sacral neuromodulation