Clinical trial NCT02856022: 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
Overall status: COMPLETED
Phase: NA
Conditions: Painful Bladder Syndrome
Keywords: electrical ilioinguinal nerve stimulation
bladder pain syndrome
intravesical irrigation
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS)
timeFrame: 4 weeks
Secondary outcomes:
measure: SF-36 questionnaire
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai research institute of acupuncture and meridian
Study officials:
affiliation: Shanghai research institute of acupuncture and meridian
name: Siyou Wang, M.D
role: STUDY_DIRECTOR
References: