Efficacy of Electrical Pudendal Nerve Stimulation for Patients With Post Prostatectomy Urinary Incontinence
Urinary Incontinence
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring Electrical pudendal nerve stimulation, Pelvic floor muscle training, Transanal electrical stimulation, Post radical prostatectomy incontinence, Comparative study
Eligibility Criteria
Inclusion Criteria:
- incontinence at 1 month or more after RP
- ≥2 incontinence episodes a week on baseline 7-day bladder diary
- no residual cancer after RP on pathological examination
Exclusion Criteria:
- the presence of preoperative incontinence
- treatment with anticholinergics
- urinary tract infection or hematuria
- postvoid residual volume>100 mL
Sites / Locations
- Shanghai research institute of acupuncture and meridian
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Electrical pudendal nerve stimulation
PFM training with Transanal ES
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.
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.