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

Primary Purpose

Pelvic Pain Syndrome

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Electrical pudendal nerve stimulation

Intravesical instillation

About this trial

This is an interventional treatment trial for Pelvic Pain Syndrome focused on measuring urethral pain syndrome, electrical pudendal nerve stimulation, intravesical instillation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

male or female patients aged 18 - 75
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.
Negative in urine routine test or urine cultivation.
agreement to sign the written informed consent.

Exclusion Criteria:

Symptoms relieved by anti-inflammatory drugs, α-blockers, muscle relaxants.
A diagnosis of bacterial cystitis or prostatitis within a 3-month period; bladder or ureteral calculi; active genital herpes; any type of cystitis; vaginitis.
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.
Female patients with pregnancy or lactation.
Serious mental disorders.

Sites / Locations

Shanghai research institute of acupuncture and meridian

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EPNS group

II group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03671993

First Posted

September 4, 2018

Last Updated

November 30, 2019

Sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

1. Study Identification

Unique Protocol Identification Number

NCT03671993

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

October 5, 2018 (Actual)

Primary Completion Date

February 10, 2019 (Actual)

Study Completion Date

March 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Pain Syndrome

Keywords

urethral pain syndrome, electrical pudendal nerve stimulation, intravesical instillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EPNS group

Arm Type

Experimental

Arm Description

Arm Title

II group

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Electrical pudendal nerve stimulation

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Intravesical instillation

Intervention Description

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 Measure Information:

Title

Pelvic Pain, Urgency and Frequency Questionnaire ( PUF questionnaire)

Description

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Visual Analogue Scale for pain

Description

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: male or female patients aged 18 - 75 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. Negative in urine routine test or urine cultivation. agreement to sign the written informed consent. Exclusion Criteria: Symptoms relieved by anti-inflammatory drugs, α-blockers, muscle relaxants. A diagnosis of bacterial cystitis or prostatitis within a 3-month period; bladder or ureteral calculi; active genital herpes; any type of cystitis; vaginitis. 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. Female patients with pregnancy or lactation. Serious mental disorders.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Siyou Wang

Organizational Affiliation

Shanghai research institute of acupuncture and meridian

Official's Role

Study Director

Facility Information:

Facility Name

Shanghai research institute of acupuncture and meridian

City

Shanghai

ZIP/Postal Code

200030

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

33934208

Citation

Li T, Feng XY, Feng XM, Lv JW, Lv TT, Wang SY. The short-term efficacy of electrical pudendal nerve stimulation versus intravesical instillation for the urethral pain syndrome: a randomized clinical trial. World J Urol. 2021 Oct;39(10):3993-3998. doi: 10.1007/s00345-021-03698-2. Epub 2021 May 2.

Results Reference

derived

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

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