A Comparison of Electrical Pudendal Nerve Stimulation and Transvaginal Electrical Stimulation for Urge Incontinence
Condition: Urge Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Urge
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether electrical pudendal nerve stimulation is
      more effective than transvaginal electrical stimulation in treating urge urinary incontinence
      (UUI).
    

Detailed description: 
      Electrical neuromodulation can be used to treat UUI refractory to medication. Electrical
      neuromodulation therapies include transvaginal or transanal electrical stimulation (TES),
      percutaneous tibial nerve stimulation (PTNS), sacral neuromodulation (SNM), and pudendal
      neuromodulation (PNM). TES is easily applicable but is sometimes intolerable for many
      patients due to discomfort, mucosal injury, and high-intensity stimulation necessary to
      obtain acceptable outcome. SNM with the InterStim device differs from TES by its continuous
      stimulation and close nerve contact. It has a high rate of success, but symptoms appear to
      recur almost immediately after discontinuation of the stimulation, and at least 20 % of
      patients initially tested do not respond to a test procedure. Its disadvantages included
      invasiveness, high cost of treatment, high surgical revision rate, device replacement
      required when battery runs out, and adverse events. PNM with the Interstim device or the Bion
      device can be used to treat UUI refractory to SNM, but this therapy also has the
      disadvantages similar to those of SNM. PTNS with needle electrodes is minimally invasive,
      demonstrates efficacy, and is easily applicable and well tolerated, but PTNS effects diminish
      over time after the end of treatment.

      By combining the advantages of PTNS and PNM and incorporating the technique of deep insertion
      of long acupuncture needles, the investigators 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). 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 pelvic floor muscle contraction, vaginal pressure and pelvic floor surface
      electromyogram in our previous study have proved that EPNS can exactly excite PN. The purpose
      of this study is to compare the efficacies of EPNS versus TES in treating female UUI.
    

Intervention name(s): Electrical pudendal nerve stimulation; Transvaginal ES
Intervention type(s): Device; Device
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 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; Transvaginal electrical stimulation; Urge urinary incontinence; Comparative study