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

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Status: Completed

Conditions: Painful Bladder Syndrome

Treatments: Procedure: Intravesical Irrigation; Device: Electrical ilioinguinal nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02856022

ZYY201606

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Electrical ilioinguinal nerve stimulation

Experimental group

Treatment:

Device: Electrical ilioinguinal nerve stimulation

Intravesical Irrigation

Active Comparator group

Treatment:

Procedure: Intravesical Irrigation