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

A Comparison of the Efficacy of Electrical Ilioinguinal Nerve Stimulation and Intravesical Irrigation in Treating Patients With Bladder Pain Syndrome in Women

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.

Study Overview

• Status: Completed
• Conditions: Painful Bladder Syndrome
• Intervention / Treatment: Device: Electrical ilioinguinal nerve stimulation; Procedure: Intravesical Irrigation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200030
    • Shanghai Research Institute of Acupuncture and Meridian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Diagnostic Criteria:

1. Complaint of suprapubic pain related to bladder filling, accompanied by other symptoms such as increased daytime and night-time frequency, in the absence of proven urinary infection or other obvious pathology.
2. Negative in urine routine test or urine cultivation.
3. Urinating at least 7 times per day or having some urgency or pain (measured on linear analog scales)

Inclusion Criteria:

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

Exclusion Criteria:

1. Bladder capacity of greater than 350 mL on awake cystometry;
2. Absence of an intense urge to void with the bladder is filled to 150 mL of liquid filling medium;
3. The demonstration of phasic involuntary bladder contractions on cystometry using the fill rate just described;
4. Duration of symptoms less than 9 months;
5. Absence of nocturia;
6. Symptoms relieved by antimicrobial agents, urinary antiseptic agents, anticholinergic agents, or antispasmodic agents;
7. A frequency of urination while awake of less than 8 times per day;
8. A diagnosis of bacterial cystitis or prostatitis within a 3-month period;
9. Bladder or ureteral calculi;
10. Active genital herpes;
11. Uterine, cervical, vaginal, or urethral cancer;
12. Urethral diverticulum;
13. Cyclophosphamide or any type of chemical cystitis;
14. Tuberculous cystitis;
15. Radiation cystitis;
16. Benign or malignant bladder tumors;
17. Vaginitis;
18. Age younger than 18 years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrical ilioinguinal nerve stimulation	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.
Active Comparator: Intravesical Irrigation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS)	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
SF-36 questionnaire	4 weeks

Collaborators and Investigators

• Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Investigators: Study Director: Siyou Wang, M.D, Shanghai Research Institute of Acupuncture and Meridian

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Actual): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: bladder pain syndrome; electrical ilioinguinal nerve stimulation; intravesical irrigation
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Disease; Cystitis; Syndrome; Cystitis, Interstitial
• Other Study ID Numbers: ZYY201606

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided