A Comparison of Electrical Ilioinguinal Nerve Stimulation With Intravesical Irrigation for Bladder Pain Syndrome
Primary Purpose
Painful Bladder Syndrome
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electrical ilioinguinal nerve stimulation
Intravesical Irrigation
Sponsored by
About this trial
This is an interventional treatment trial for Painful Bladder Syndrome focused on measuring electrical ilioinguinal nerve stimulation, bladder pain syndrome, intravesical irrigation
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.
Sites / Locations
- Shanghai research institute of acupuncture and meridian
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Electrical ilioinguinal nerve stimulation
Intravesical Irrigation
Arm Description
Outcomes
Primary Outcome Measures
Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS)
Secondary Outcome Measures
SF-36 questionnaire
Full Information
NCT ID
NCT02856022
First Posted
August 2, 2016
Last Updated
July 27, 2017
Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
1. Study Identification
Unique Protocol Identification Number
NCT02856022
Brief Title
A Comparison of Electrical Ilioinguinal Nerve Stimulation With Intravesical Irrigation for 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Bladder Syndrome
Keywords
electrical ilioinguinal nerve stimulation, bladder pain syndrome, intravesical irrigation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electrical ilioinguinal nerve stimulation
Arm Type
Experimental
Arm Title
Intravesical Irrigation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Electrical ilioinguinal nerve stimulation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intravesical Irrigation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
SF-36 questionnaire
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siyou Wang, M.D
Organizational Affiliation
Shanghai research institute of acupuncture and meridian
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai research institute of acupuncture and meridian
City
Shanghai
ZIP/Postal Code
200030
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Comparison of Electrical Ilioinguinal Nerve Stimulation With Intravesical Irrigation for Bladder Pain Syndrome
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