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

Efficacy of Electrical Pudendal Nerve Stimulation and Sacral Neuromodulation in Treating Non-obstructive Neurogenic Urinary Retention: A Nonrandomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Urinary Retention
• Intervention / Treatment: Procedure: electrical pudendal nerve stimulation; Procedure: sacral neuromodulation

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200030
    • Shanghai Research Institute of Acupuncture and Meridian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EPNS group	Procedure: electrical pudendal nerve stimulation; The patient was positioned prone post-micturition. Long needles (0.40 Х 100 mm) were inserted perpendicularly, 1 cm bilateral to the sacrococcygeal joint, to a depth of 80-90 mm, eliciting sensations referred to the urethra or anus. The lower points, 1 cm bilateral to the coccyx tip, received oblique insertion of longer needles (0.40 Х 125 mm) toward the ischiorectal fossa (90-110 mm depth), inducing sensations precisely to the urethra. Connected to a G6805-2 Multi-Purpose Health Device, the ipsilateral needles created an electric loop, with the upper as anode and lower as cathode. Direct electrical stimulation (2.5 Hz, 25~35 mA) for 60 minutes targeted the pudendal nerve, thrice weekly for a total of 4 weeks.
Active Comparator: SNM group	Procedure: sacral neuromodulation; In the prone position, patients undergo sacral nerve root localization through MRI and CT fusion analysis. A 3D-printed sacral foramen puncture template is crafted for precision. Using local anesthesia, a 20G needle at a 60° angle enters the S3 sacral foramen along the template. A temporary stimulator, delivering square waves (14-35 Hz, 210-360 μs), tests motor and sensory responses to confirm accuracy. Self-fixating electrodes are then implanted, validated, and tunneled subcutaneously. External connection to a temporary stimulator provides a 4-week therapeutic experiential stimulation.Patients are administrated by antibiotics peri-operatively to prevent lead site infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in pre-post treatment post-voiding residual urine volume (PVR )	Bladder PVR is measured by ultrasound.Percent change in pre-post treatment PVR is calculated as (baseline PVR - post-treatment PVR) / baseline PVR × 100%.	baseline (T0), mid-treatment (T1; after 6 EPNS sessions or 2 weeks of SNM), and (T2; after 12 EPNS sessions or 4 weeks of SNM)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute post-voiding residual volume (PVR) at the end of treatment; International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms (ICIQ-LUTS) and the quality of life (ICIQ-LUTSqol) score.	Absolute PVR <50 mL is regarded as a clinically meaningful target; ICIQ-LUTS and ICIQ-LUTSqol are two patient-reported outcomes	Mid-treatment (T1; after 6 EPNS sessions or 2 weeks of SNM), and (T2; after 12 EPNS sessions or 4 weeks of SNM)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
achievement of ≥50% PVR improvement rate and composite achievement (requiring both PVR <50 mL and ≥50% PVR improvement rate)	Binary clinical targets (achievement / failure)	mid-treatment (T1; after 6 EPNS sessions or 2 weeks of SNM), and (T2; after 12 EPNS sessions or 4 weeks of SNM)

Collaborators and Investigators

• Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Collaborators: Shanghai Yueyang Integrated Medicine Hospital; Shanghai Pudong Hospital of TCM

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urinary Retention
• Other Study ID Numbers: 2018-099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No