Urinary Retention
Conditions
Brief 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.
Interventions
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.
PROCEDUREsacral 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.
Sponsors
Shanghai Pudong Hospital of TCM
Shanghai Yueyang Integrated Medicine Hospital
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in pre-post treatment post-voiding residual urine volume (PVR ) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| achievement of ≥50% PVR improvement rate and composite achievement (requiring both PVR <50 mL and ≥50% PVR improvement rate) | 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) |
Countries
China
Outcome results
None listed