Clinical Effect Observation for Electrical Pudendal Nerve Stimulation in Treating Urethral Pain Syndrome
Condition: Pelvic Pain Syndrome
MeSH terms: Syndrome; Pelvic Pain; Somatoform Disorders
Study type: Interventional

Summary: 
      In this randomized controlled trial, we intend to determine whether electrical pudendal nerve
      stimulation is more effective than intravesical instillation in urethral pain syndrome.
    

Detailed description: 
      According to the 2017 edition of European Association of Urology Guideline, there is no
      specific treatment for urethral pain syndrome (UPS), and it is recommended this type of
      patients should be treated in a multi-disciplinary and multi-modal program. Since some
      mechanisms for the development of UPS suggest it may be a form of bladder pain syndrome (BPS)
      due to the intimate relation of the urethra with the bladder (both covered with urothelium),
      a combination of intravesical hyaluronic acid and lidocaine plus sodium bicarbonate, the more
      widely used regimen for BPS in China, is also applied to UPS here in China. However, the
      symptom relief of the intravesical irrigation won't last long and patients usually report
      recurrence in 2-3 weeks. Hence, the purpose of this study is to explore whether the
      electrical pudendal nerve stimulation（EPNS）, which has been proven effective in treating BPS,
      is more effective than intravesical instillation (intravesical hyaluronic acid and lidocaine
      plus sodium bicarbonate) in patients with UPS.
    

Intervention name(s): Electrical pudendal nerve stimulation; Intravesical instillation
Intervention type(s): Procedure; Procedure
Intervention description(s): 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 sessions per week for 6 weeks.; The patient should lie on a couch in a lithotomy position after urination. A catheter was passed through the urethra into the bladder and any residual urine should be drained. A mixture of the Cystistat (sodium hyaluronate, 50ml 40mg, Bioniche Teoranta, Ireland) solution and Lidocaine hydrochloride (40mg :20ml, Fangming Pharmacy company, Shangdong, China) is instilled through the catheter into the bladder. The catheter is then withdrawn leaving the mixture solution inside the bladder, retained for as long as possible, ideally at least 30 minutes. The instillation is once weekly for at 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: urethral pain syndrome; electrical pudendal nerve stimulation; intravesical instillation