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

September 10, 2025 updated by: Shanghai Institute of Acupuncture, Moxibustion and Meridian

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent change in pre-post treatment post-voiding residual urine volume (PVR )
Time Frame: 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)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: Mid-treatment (T1; after 6 EPNS sessions or 2 weeks of SNM), and (T2; after 12 EPNS sessions or 4 weeks of SNM)
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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)
Time Frame: mid-treatment (T1; after 6 EPNS sessions or 2 weeks of SNM), and (T2; after 12 EPNS sessions or 4 weeks of SNM)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Institute of Acupuncture, Moxibustion and Meridian

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Yueyang Integrated Medicine Hospital
Shanghai Pudong Hospital of TCM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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