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

Not Applicable

Completed

• Conditions: Painful Bladder Syndrome
• Interventions: Device: Electrical ilioinguinal nerve stimulation; Procedure: Intravesical Irrigation

• Registration Number: NCT02856022
• Lead Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

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.

Study Timeline

• Study Start: 2014-07
• Status Verified: 2016-06
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-03
• Study First Posted: 2016-08-04
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrical ilioinguinal nerve stimulation	Electrical ilioinguinal nerve stimulation	-
Intravesical Irrigation	Intravesical Irrigation	-

Primary Outcome Measures

Name	Time	Method
Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS)	4 weeks

Secondary Outcome Measures

Name	Time	Method
SF-36 questionnaire	4 weeks

Trial Locations

Locations (1)

Shanghai research institute of acupuncture and meridian; 🇨🇳 Shanghai, China