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

Painful Bladder Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856022
• Other study ID #: ZYY201606
• Status: Completed
• Phase: N/A
• First received: August 2, 2016
• Last updated: July 27, 2017
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystitis, Interstitial
• Painful Bladder Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai research institute of acupuncture and meridian	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Institute of Acupuncture, Moxibustion and Meridian

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS)		4 weeks
Secondary	SF-36 questionnaire		4 weeks