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A Comparison of Electrical Ilioinguinal Nerve Stimulation With Intravesical Irrigation for Bladder Pain Syndrome

NCT02856022 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-07-31

No results posted yet for this study

Summary

The purpose of this study is to determine whether electrical ilioinguinal nerve stimulation (EINS) is more effective than intravesical irrigation (II) in treating bladder pain syndrome.

Conditions

  • Painful Bladder Syndrome

Interventions

DEVICE

Electrical ilioinguinal nerve stimulation

Four abdominal points are selected. The upper two points are located 2.5 cun bilateral to Guanyuan (Ren 4). The lower two points are located 1.5 cun bilateral to Zhongji (Ren 3). Four long needles are punctured obliquely 1\~2 cun in depth (depending on the fat layer thickness of the patient) to the four points to make the needling sensation reaching the urethra or vulva. After the needling sensation reach the above regions, each of two pairs of electrodes from a device are connected with the two ipsilaterally inserted needles. The parameters are continuous waves, a frequency of 2.5 Hz and intensity that the patient feels comfortable for 60 min, three times a week for at least four weeks.

PROCEDURE

Intravesical Irrigation

The patient was asked to lie on a couch in a lithotomy position after urination. A catheter was passed through the urethra into the bladder and any residual urine drained. The Cystistat 50mL 40mg (sodium hyaluronate, Bioniche Teoranta, Ireland) solution is instilled through the catheter into the bladder. The catheter is then withdrawn leaving the Cystistat inside the bladder coating the lining. It was recommended the solution was retained for as long as possible, ideally at least 30 minutes. The instillation is once weekly for at least four weeks.

Sponsors & Collaborators

  • Shanghai Institute of Acupuncture, Moxibustion and Meridian

    lead OTHER

Principal Investigators

  • Siyou Wang, M.D · Shanghai research institute of acupuncture and meridian

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02856022 on ClinicalTrials.gov