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

NCT02856022 | Completed DMC

• 1 other identifier: ZYY201606
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

electrical ilioinguinal nerve stimulation; bladder pain syndrome; intravesical irrigation

Outcome Measures

Primary Outcomes (1)

• Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS)

  4 weeks

Secondary Outcomes (1)

• SF-36 questionnaire

  4 weeks

Study Arms (2)

Electrical ilioinguinal nerve stimulation

EXPERIMENTAL

Device: Electrical ilioinguinal nerve stimulation

Intravesical Irrigation

ACTIVE COMPARATOR

Procedure: Intravesical Irrigation

Interventions

Electrical ilioinguinal nerve stimulation DEVICE

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.

Electrical ilioinguinal nerve stimulation

Intravesical Irrigation PROCEDURE

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 The catheter is then withdrawn leaving the Cystistat inside the bladder coating the lining.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.

Intravesical Irrigation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Providing informed consent to participate in the study;
• Willing to undergo a cystoscopy under general or regional anesthesia when indicated during the course of the study;
• Female patients meeting the diagnostic criteria;
• Age ≥18 years and ≤80 years.
• Disease course ≥ 6 months

You may not qualify if:

• Bladder capacity of greater than 350 mL on awake cystometry;
• Absence of an intense urge to void with the bladder is filled to 150 mL of liquid filling medium;
• The demonstration of phasic involuntary bladder contractions on cystometry using the fill rate just described;
• Duration of symptoms less than 9 months;
• Absence of nocturia;
• Symptoms relieved by antimicrobial agents, urinary antiseptic agents, anticholinergic agents, or antispasmodic agents;
• A frequency of urination while awake of less than 8 times per day;
• A diagnosis of bacterial cystitis or prostatitis within a 3-month period;
• Bladder or ureteral calculi;
• Active genital herpes;
• Uterine, cervical, vaginal, or urethral cancer;
• Urethral diverticulum;
• Cyclophosphamide or any type of chemical cystitis;
• Tuberculous cystitis;
• Radiation cystitis;

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead

Study Sites (1)

Shanghai research institute of acupuncture and meridian

Shanghai, 200030, China

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Siyou Wang, M.D

  Shanghai research institute of acupuncture and meridian

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 4, 2016
• Study Start: July 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 31, 2017

Record last verified: 2016-06

Locations

CN (1)