Comparison of Electrical Pudendal Nerve Stimulation and Tolterodine Tartrate for Urgency-Frequency Syndrome in Women
Condition: Urgency-frequency Syndrome
MeSH terms: Urinary Bladder, Overactive; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of electrical pudendal nerve stimulation
      (EPNS) and Tolterodine Tartrate in patients with urgency-frequency syndrome.
    

Detailed description: 
      Tolterodine Tartrate is one of the first-line medications in treatment of Urgency-frequency
      syndrome (UFS) patients. It is reported to reduce frequency urgency and nocturia and urinary
      leakage in patients with UFS. However dry mouth and constipation are the most frequently
      reported adverse events. In other reports blurred vision and increased heart rate are also
      reported. The side effects limit its application.

      Electrical neuromodulation has proved to be valuable in patients with UFS with little adverse
      effect. The investigators have previously reported electrical pudendal nerve stimulation
      (EPNS) alone has long term effect in treatment of UFS in women patients. EPNS is developed by
      combining the advantages of pudendal nerve stimulation (PNS) and percutaneous tibial nerve
      stimulation (PTNS), and incorporating the technique of deep insertion of long acupuncture
      needles. Because pudendal nerve (PN) afferents are particularly important for the inhibitory
      effect on the voiding reflex and SNS only excites part of PN afferents, direct PN stimulation
      may be more effective. PNS can be used to treat UFS refractory to SNS, but this therapy also
      has the disadvantages similar to those of SNS. PTNS is minimally invasive, demonstrates
      efficacy, and is easily applicable and well tolerated, but the results of chronic PTNS
      treatment are unknown in initially successful patients and PTNS effects diminish over time.

      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. 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 the investigators
      previous study have proved that EPNS can exactly excite PN. The investigators previous study
      has also proved that EPNS has a good post-treatment effect on UFS in women. The purpose of
      the present study is to show the long-term efficacy of EPNS for UFS in women.
    

Intervention name(s): EPNS; TT
Intervention type(s): Behavioral; Drug
Intervention description(s): Electrical pudendal nerve stimulation 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.; Tolterodine tartrate (GSK， UK) 4mg per day is taken orally for six weeks
Other intervention name(s): electrical pudendal nerve stimulation; Tolterodine tartrate
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Urgency-frequency Syndrome; Electrical Pudendal Nerve Stimulation; Tolterodine Tartrate