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

Pelvic Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03671993
• Other study ID #: ShanghaiIAMM
• Status: Completed
• Phase: N/A
• Start date: October 5, 2018
• Est. completion date: March 10, 2019

Study information

• Verified date: September 2018
• Source: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 10, 2019
• Est. primary completion date: February 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. male or female patients aged 18 - 75

2. Occurrence of chronic or recurrent episodic pain perceived in the urethra, especially related to micturition, for more than 3 months; accompanied by other symptoms such as increased daytime and night-time frequency, in the absence of proven infection or other obvious urethral pathology such as urethral diverticulum.

3. Negative in urine routine test or urine cultivation.

4. agreement to sign the written informed consent.

Exclusion Criteria:

1. Symptoms relieved by anti-inflammatory drugs, a-blockers, muscle relaxants.

2. A diagnosis of bacterial cystitis or prostatitis within a 3-month period; bladder or ureteral calculi; active genital herpes; any type of cystitis; vaginitis.

3. life threatening complication such as uterine, cervical, vaginal, or urethral cancer, bladder tumor, heart failure, cardiovascular disease, hemorrhagic disease, uncontrolled diabetes, and/or factors that can affect hemostasis.

4. Female patients with pregnancy or lactation.

5. Serious mental disorders.

Related Conditions & MeSH terms

• Pelvic Pain
• Pelvic Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Procedure:
• Electrical pudendal nerve stimulation
Four sacrococcygeal points were selected. Two 0.40?100 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 0.40?100 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.
• 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.

Locations

Country	Name	City	State
China	Shanghai research institute of acupuncture and meridian	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Institute of Acupuncture, Moxibustion and Meridian

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic Pain, Urgency and Frequency Questionnaire ( PUF questionnaire)	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.	6 weeks
Secondary	Visual Analogue Scale for pain	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.	6 weeks