Clinical Effect Observation for Electrical Pudendal Nerve Stimulation in Treating Urethral Pain Syndrome

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 5, 2018

Primary Completion Date

February 10, 2019

Study Completion Date

March 10, 2019

Conditions
Pelvic Pain Syndrome
Interventions
PROCEDURE

Electrical pudendal nerve stimulation

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.

PROCEDURE

Intravesical instillation

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 The catheter is then withdrawn leaving the mixture solution inside the bladder, retained for as long as possible, ideally at least 30 minutes.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.

Trial Locations (1)

200030

Shanghai research institute of acupuncture and meridian, Shanghai

All Listed Sponsors
lead

Shanghai Institute of Acupuncture, Moxibustion and Meridian

OTHER

NCT03671993 - Clinical Effect Observation for Electrical Pudendal Nerve Stimulation in Treating Urethral Pain Syndrome | Biotech Hunter | Biotech Hunter