An interventional study of Electrical pudendal nerve stimulation and PFM training in Urinary Incontinence, sponsored by Shanghai Institute of Acupuncture, Moxibustion and Meridian. Completed at 1 site in China. Open to male participants aged 25 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by Shanghai Institute of Acupuncture, Moxibustion and Meridian · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether electrical pudendal nerve stimulation is more effective than pelvic floor muscle training plus transanal electrical stimulation in treating post prostatectomy Incontinence.
Conservative therapy could be considered a choice of treatment for stress urinary incontinence (SUI) as it seems to have no side effect and causes significant and long-term improvement in symptoms. Pelvic floor muscle training (PFMT) and electrical stimulation are two commonly used forms of conservative treatment for SUI. PFMT improves the structural support of the pelvis. However, many patients have difficulty identifying and isolating their pelvic floor muscles (PFM) and are unable to perform the exercise effectively. Furthermore, patients who can identify the PFM often find that the required daily exercise routine is burdensome. Hence, the primary disadvantage of PFMT is lack of long-term patient compliance. Electrical stimulation (ES) is a non-invasive, passive treatment that produces a muscle contraction. Transanal electrical stimulation (TES) has little side-effect, and the patient compliance is 70-85% in published reports. TES results in PFM contraction by indirect nerve stimulation, mainly by polysynaptic reflex responses. The indirect stimulation and reflexive contraction may be the reason why the effect of electrical stimulation is not as good as that of PFMT when performed correctly. By combining the advantages of PFMT and TES and incorporating the technique of deep insertion of long acupuncture needles, we developed electrical pudendal nerve stimulation (EPNS). In EPNS, long acupuncture needles of 0.40 Х 100 or 125 mm were deeply inserted into four sacral points and electrified to stimulate the pudendal nerves (PN) and contract the PFM. CT transverse plane at the coccygeal apex has showed that the position of the lower needle tip is similar to where (adjacent to PN at Alcock's canal) the Bion device is implanted for chronic PN stimulation. Our previous study showed that EPNS had a better therapeutic effect on female SUI as compared with PFMT + TES. Simultaneous records of perineal ultrasonographic PFM contraction, vaginal pressure and pelvic floor surface electromyogram in our previous study have proved that EPNS can exactly excite PN and induce PFM contraction in female SUI patients. However, EPNS has also shown satisfactory effect in male patients with SUI problems. The purpose of this study is to compare the efficacy of EPNS to PFMT + TES in treating male SUI.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 96 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
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Exclusion Criteria:
Four sacrococcygeal points were selected. Two 0.40Х100 mm needles were inserted perpendicularly to a depth of 80-90 mm 1 cm bilateral to the sacrococcygeal joint, to produce a sensation referred to the root of the penis (perineum) or the anus. Two needles of 0.40Х100 or 125mm were inserted obliquely toward the ischiorectal fossa to a depth of 90 to 110 mm about 1 cm bilateral to the tip of the coccyx, to produce a sensation referred to the root of the penis (or the perineum). Each two ipsilaterally needles were connected to one electrode from a G6805-2Multi-Purpose Health Device (Shanghai Medical Instruments High-Techno, Shanghai, China), with a frequency of 2.5 Hz and an intensity (45\~55 mA). EPNS was given for 60 min a time, 3 times per week for 8 weeks.
Device: Electrical pudendal nerve stimulation
Electromyogram BF-assisted PFMT (using a nerve function reconstruction treatment system (AM1000B; Shenzhen Creative Industry Co. Ltd, China) and following TES (using a neuromuscular stimulation therapy system (PHENIX USB4, Electronic Concept Lignon Innovation, France)) at a current intensity of \< 60 mA (as high as possible within the patient's tolerance) and frequencies of 15 Hz and 85 Hz (alternate 3-minute periods of stimulation) were performed by a specially trained therapist, 20 minutes each time, respectively (a total of 40 minutes), 3 times a week for a total of 8 weeks. The patients were also required to conduct 30 maximal high-intensity PFM contractions for 2-6 seconds (with 2-6 seconds rest), 3 sessions every day at home for a total of 8 weeks.
Device: PFM training · Device: Transanal ES
Four sacrococcygeal points are selected. The two upper points are located about 1 cm bilateral to the sacrococcygeal joint. On the upper points, a needle of 0.40 Х 100 mm is inserted perpendicularly to a depth of 80 to 90 mm to produce a sensation referred to the root of the penis (perineum) or the anus. The locations of the two lower points are about 1 cm bilateral to the tip of the coccyx. On the lower points, a needle of 0.40 Х 100 or 125 mm is inserted obliquely towards the ischiorectal fossa to a depth of 90 to 110 mm to produce a sensation referred to the root of the penis (perineum). 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 inserted needles.
Also known as: G6805-2 Multi-Purpose Health Device
A nerve function reconstruction treatment system (AM1000B; Shenzhen Creative Industry Co.Ltd, China) is used for EMG-biofeedback assisted PFMT.
Also known as: AM1000B (Shenzhen Creative Industry Co.Ltd, China)
A neuromuscular stimulation therapy system (PHENIX USB 4，Electronic Concept Lignon Innovation, France) is used for TES
ICIQ-UI-SF
International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form
Time frame: 8 weeks
diaper numbers
none, 1-3 per week, 4-6 per week, 1-4 per day and more than 4 per day are scored 0, 1, 2, 3 and 4 respectively
Time frame: 8 weeks
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Shanghai Institute of Acupuncture, Moxibustion and Meridian