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NCT Number: NCT06158074

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

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.

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Key information

Conditions

Urinary Retention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai research institute of acupuncture and meridian

Shanghai, 200030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electrical pudendal nerve stimulation

Procedure

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.

Sacral neuromodulation

Procedure

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.

Primary outcomes

  1. 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%.

Secondary outcomes

  1. 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

Other outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Other

Collaborators

  • Shanghai Pudong Hospital of TCM
  • Shanghai Yueyang Integrated Medicine Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2023
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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