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

NCT03671993 | Completed DMC

• 1 other identifier: ShanghaiIAMM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Pain Syndrome

Keywords

urethral pain syndrome; electrical pudendal nerve stimulation; intravesical instillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visual Analogue Scale for pain

  6 weeks

Study Arms (2)

EPNS group

EXPERIMENTAL

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

II group

ACTIVE COMPARATOR

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

Interventions

Electrical pudendal nerve stimulation PROCEDURE

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.

EPNS group

Intravesical instillation PROCEDURE

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.

II group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead

Study Sites (1)

Shanghai research institute of acupuncture and meridian

Shanghai, 200030, China

Location

Related Publications (1)

• 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.

  PMID: 33934208 DERIVED

MeSH Terms

Interventions

Administration, Intravesical

Intervention Hierarchy (Ancestors)

Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Siyou Wang

  Shanghai research institute of acupuncture and meridian

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 14, 2018
• Study Start: October 5, 2018
• Primary Completion: February 10, 2019
• Study Completion: March 10, 2019
• Last Updated: December 3, 2019

Record last verified: 2018-09

Locations

CN (1)