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

Urinary Retention Clinical Trial

Official title:

Efficacy of Electrical Pudendal Nerve Stimulation and Sacral Neuromodulation in Treating Non-obstructive Neurogenic Urinary Retention: A Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06158074
• Other study ID #: 2018-099
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Contact: Siyou Wang, M.M.
• Phone: 86 13916145984
• Email: wangsiyou1234[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Urinary Retention

Intervention

Procedure:
• electrical pudendal nerve stimulation
The patient was positioned prone post-micturition. Long needles (0.40 ? 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 ? 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
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.

Locations

Country	Name	City	State
China	Shanghai research institute of acupuncture and meridian	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Institute of Acupuncture, Moxibustion and Meridian	Shanghai Pudong Hospital of TCM

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder residual urine volume measured by ultrasound	Bladder residual urine volume measured by ultrasound	T0 (baseline); T1 (week 2); T2 (week 4)