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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Painful Bladder Syndrome

Intervention / Treatment
-----------------
* Device: Electrical ilioinguinal nerve stimulation
* Procedure: Intravesical Irrigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Diagnostic Criteria: 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. Negative in urine routine test or urine cultivation. Urinating at least 7 times per day or having some urgency or pain (measured on linear analog scales) Inclusion Criteria: 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 Exclusion Criteria: 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; Benign or malignant bladder tumors; Vaginitis; Age younger than 18 years.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrical ilioinguinal nerve stimulation<br> | Device: Electrical ilioinguinal nerve stimulation<br>* 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.<br>|
| Active Comparator: Intravesical Irrigation<br> | Procedure: Intravesical Irrigation<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 questionnaire |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
electrical ilioinguinal nerve stimulation, bladder pain syndrome, intravesical irrigation