An interventional study of Electrical pudendal nerve stimulation and Transvaginal electrical stimulation in Spinal Cord Injuries, Lower Urinary Tract Symptoms and Dysuria, sponsored by Shanghai Institute of Acupuncture, Moxibustion and Meridian. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-28.
Sponsored by Shanghai Institute of Acupuncture, Moxibustion and Meridian · Not applicable, Interventional, and Treatment
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 30 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Shanghai Institute of Acupuncture, Moxibustion and Meridian is the lead sponsor of 29 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Electrical pudendal nerve stimulation At a frequency of 2.0 Hz and a moderate intensity (25\~35 mA); 60 minutes three times a week for a total of four weeks
Device: Electrical pudendal nerve stimulation
At a current intensity of \< 60 mA (as high as possible to get a contraction) and frequencies of 15 Hz and 85 Hz (alternate 3-min periods of stimulation); 30 min three times a week for a total of four weeks.
Device: Transvaginal electrical stimulation
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
A questionaire to measure the severity of lower urinary tract symptoms (male/female)
Time frame: 1.5 years
A questionaire to evaluate the Qol
Time frame: 1.5 years
Residual urine volume
Time frame: 1.5 years
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Shanghai Institute of Acupuncture, Moxibustion and Meridian