Spinal Cord Injuries, Lower Urinary Tract Symptoms, Dysuria, Incontinence
Conditions
Keywords
pudendal nerve modulation, transanal/transvaginal electrical stimulation
Brief summary
The main goal to treat early NLUTS is to relieve lower urinary tract syndrome and prevent from late complications. The present study is to evaluate the efficacy of electrical pudendal nerve stimulation (EPNS) and transanal/transvaginal electrical stimulation (TES) in NLUTD.The study design consists of a non-randomized, parallel controlled trial. A total of 60 eligible patients will be involved and divided into EPNS or TES group according to their location of medical treatment. The primary endpoint is lower urinary tract syndromes (ICIQ-FLUTS/MLUTS). The second endpoint is assessment of daily life Qol (ICIQ-LUTSqol), and residual urine volume.
Interventions
Four sacral points are selected. The two upper points are located about 1 cm bilateral to the sacrococcygeal joint. Needles of 0.40 Х 100 mm are inserted perpendicularly to the upper points to a depth of 80 to 90 mm to produce a sensation referred to the urethra or the anus. The two lower points are about 1 cm bilateral to the tip of the coccyx. Needles of 0.40 Х 100 or 125 mm are inserted obliquely to the lower points towards the ischiorectal fossa to a depth of 90 to 110 mm to produce a sensation referred to the urethra. After the sensation referred to the above regions is produced, each of two pairs of electrodes from a G6805-2 Multi-Purpose Health Device is connected with the two ipsilaterally needles.
A neuromuscular stimulation therapy system (PHENIX USB 4，Electronic Concept Lignon Innovation, France) is used for TES
Sponsors
RenJi Hospital
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18+ years; * Diagnosed as NLUTD; * Incomplete spinal cord injury (SCI), including but not limited to conus medullaris syndrome, cauda equina syndrome, etc.; * Radical pelvic surgery: including but not limited to total hysterectomy etc.; * Informed consent signed.
Exclusion criteria
* Anatomical bladder outlet obstruction (e.g., prostate enlargement, tumors); * NLUTD induced by stroke, multiple sclerosis, HIV, diabetes mellitus, drug, and inflammation or tumor of central nervous system etc.; * Lower urinary tract infections; * Unwillingness to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A questionaire to measure the severity of lower urinary tract symptoms (male/female) | 1.5 years |
Secondary
| Measure | Time frame |
|---|---|
| A questionaire to evaluate the Qol | 1.5 years |
| Residual urine volume | 1.5 years |
Countries
China
Outcome results
None listed