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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
Sponsor:
Information provided by (Responsible Party):
Shanghai Institute of Acupuncture, Moxibustion and Meridian

Brief 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.

Condition or disease Intervention/treatment Phase
Pelvic Pain Syndrome Procedure: Electrical pudendal nerve stimulation Procedure: Intravesical instillation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, α-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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671993


Contacts
Contact: Xiaoming Feng, Ph.D 86-13636615026 fengtcm@126.com
Contact: Tian Li 86-15216715185 alasoka@163.com

Locations
China
Shanghai research institute of acupuncture and meridian Recruiting
Shanghai, China, 200030
Contact: Xiaoming Feng, Ph.D    86-13636615026    fengtcm@126.com   
Principal Investigator: Siyou Wang, Master         
Sponsors and Collaborators
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Investigators
Study Director: Siyou Wang Shanghai research institute of acupuncture and meridian

Responsible Party: Shanghai Institute of Acupuncture, Moxibustion and Meridian
ClinicalTrials.gov Identifier: NCT03671993     History of Changes
Other Study ID Numbers: ShanghaiIAMM
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai Institute of Acupuncture, Moxibustion and Meridian:
urethral pain syndrome
electrical pudendal nerve stimulation
intravesical instillation

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Pelvic Pain
Disease
Pathologic Processes
Mental Disorders
Pain
Neurologic Manifestations
Signs and Symptoms