Clinical Effect Observation for Electrical Pudendal Nerve Stimulation in Treating Urethral Pain Syndrome
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|ClinicalTrials.gov Identifier: NCT03671993|
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : October 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Pain Syndrome||Procedure: Electrical pudendal nerve stimulation Procedure: Intravesical instillation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Clinical Effect Observation for Electrical Pudendal Nerve Stimulation in Treating Urethral Pain Syndrome|
|Actual Study Start Date :||October 5, 2018|
|Estimated Primary Completion Date :||February 10, 2019|
|Estimated Study Completion Date :||March 10, 2019|
Experimental: EPNS group
Electrical pudendal nerve stimulation (EPNS) is a type of conservative treatment which can directly modulate the pudendal nerve and produce a regulation effects on both the sensory fibers and the motor fibers of pudendal nerve.
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.
Active Comparator: II group
Intravesical instillation (II) are mixture solution administered due to poor oral bio-availability establishing high drug concentrations within the bladder, with few systemic side-effects.
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.
- Pelvic Pain, Urgency and Frequency Questionnaire ( PUF questionnaire) [ Time Frame: 6 weeks ]This instrument consists of eight items that cover areas of pain, urgency, urinary frequency, and symptoms associated with sexual intercourse. The score ranges from 0 to 35 points. Each participant will be evaluated by using the PUF at baseline, three weeks after the treatment commencement and six weeks after the treatment commencement, and we are about to record the mean change of the overall score of this questionnaire.
- Visual Analogue Scale for pain [ Time Frame: 6 weeks ]Participants will be asked to mark the degree of pain in urethral on a 10-mm VAS, with "0" indicating no pain and "10" indicating the worst painimaginable. Each participant will be evaluated by using this instrument at baseline, three weeks after the treatment commencement and six weeks after the treatment commencement, and we are about to record the mean change of the score.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671993
|Contact: Xiaoming Feng, Ph.Demail@example.com|
|Contact: Tian Lifirstname.lastname@example.org|
|Shanghai research institute of acupuncture and meridian||Recruiting|
|Shanghai, China, 200030|
|Contact: Xiaoming Feng, Ph.D 86-13636615026 email@example.com|
|Principal Investigator: Siyou Wang, Master|
|Study Director:||Siyou Wang||Shanghai research institute of acupuncture and meridian|