Efficacy of Electrical Pudendal Nerve Stimulation for Patients With Post Prostatectomy Urinary Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Electrical pudendal nerve stimulation; PFM training; Transanal ES
Intervention type(s): Device; Device; Device
Intervention description(s): 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.; A nerve function reconstruction treatment system (AM1000B; Shenzhen Creative Industry Co.Ltd, China) is used for EMG-biofeedback assisted PFMT.; A neuromuscular stimulation therapy system (PHENIX USB 4，Electronic Concept Lignon Innovation, France) is used for TES
Other intervention name(s): G6805-2 Multi-Purpose Health Device; AM1000B (Shenzhen Creative Industry Co.Ltd, China)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Electrical pudendal nerve stimulation; Pelvic floor muscle training; Transanal electrical stimulation; Post radical prostatectomy incontinence; Comparative study