NCT03671993

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pelvic Pain Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-10-05
• Primary completion: 2019-02-10
• Completion: 2019-03-10
• First posted: 2018-09-14
• Last updated: 2019-12-03

Locations

1 site across 1 country: China