NCT06158074

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Urinary Retention

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-11-30
• Completion: 2024-12-31
• First posted: 2023-12-06
• Last updated: 2025-09-16

Locations

1 site across 1 country: China