A Comparison of Electrical Pudendal Nerve Stimulation and Pelvic Floor Muscle Training for Female Stress Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
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 with Transvaginal electrical stimulation in
      treating female stress incontinence.
    

Detailed description: 
      Conservative therapy could be considered a choice of treatment for stress urinary
      incontinence (SUI) as it seems to have no side effects 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-especially
      women-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. Transvaginal electrical stimulation (TES) has almost no side-effects and patient
      compliance in published reports is 70-85%. TES will result 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. Besides the radiographic evidence, 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,contract the PFM and simulate
      PFMT. Our previous study has also proved that EPNS has a good therapeutic effect on female
      SUI. The purpose of this study is to compare the efficacy of EPNS to PFMT with TES in
      treating female SUI.
    

Intervention name(s): Electrical pudendal nerve stimulation; PFM training; Transvaginal ES
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Four sacral 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 urethra 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 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 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Electrical pudendal nerve stimulation; Pelvic floor muscle training; Transvaginal electrical stimulation; Stress urinary incontinence; Comparative study