Painful Bladder Syndrome
Conditions
Keywords
electrical ilioinguinal nerve stimulation, bladder pain syndrome, intravesical irrigation
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.
Interventions
DEVICEElectrical 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.
PROCEDUREIntravesical 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 The catheter is then withdrawn leaving the Cystistat inside the bladder coating the lining.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.
Sponsors
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| SF-36 questionnaire | 4 weeks |
Countries
China
Outcome results
None listed