interstitial cystitis/bladder pain syndrome, IC/BPS
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18-65 years 2. The previous diagnosis was IC/BPS duration =6 months 3. Pain Visual Analogue Scale (VAS) score =4 points 4. O 'Leary-Sant interstitial bladder inflammation signs and problems index score =12 points 5. Patients with pelvic pain and urgent/frequent urination had a Symptom Scale (PUF) score of =13 6. Have failed at least two accepted treatments 7. Serum pregnancy tests were negative and contraception was used during the study 8. Volunteer to participate in this trial and sign the informed consent exclusion criteria
Exclusion criteria
Exclusion criteria: 1. Patients who do not meet inclusion criteria 2. Patients with overactive bladder, cystitis and other diseases 3. Patients with liver and kidney failure 4. Patients known to be allergic to the investigational drug, including lidocaine, vitamin B12, and compound Betamethasone 5. Pregnant and lactating women 6. Patients with severe heart, lung, brain, liver, kidney and hematopoietic system diseases, mental diseases and obvious cognitive dysfunction 7. Patients with poor compliance, failure to follow the prescribed regimen, or failure to complete the full course of treatment, and self-addition of other therapeutic measures, thus affecting the efficacy and safety evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global response assessment scale(GRA) score at week 6; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual analogue scale(VAS) scores of pain and urgent urination at week 1, 3, 6, 8 and 12;Hospital anxiety and depression scale(HADS) score at week 1, 3, 6, 8 and 12;5-level EQ-5D version scores(EQ-5D-5L) at week 1, 3, 6, 8 and 12;Pelvic pain and frequent urination Symptom Questionnaire (PUF) scores at week 1, 3, 6, 8, and 12;Proportion of patients with a 30% reduction in pain intensity from baseline at weeks 3, 6, and 8;The adverse reactions during the whole study included vertigo, nausea, vomiting, palpitation, headache, blurred vision, muscle weakness, blood glucose level disorder, etc;Global response assessment scale(GRA) scores at week 1, 3, 8 and 12;Effectiveness of global response assessment scale(GRA) at week 6 and 12;Interstitial Cystitis Symptom Index and Problem Index (ICSI-ICPI) at week 1, 3, 6, 8, and 12;Emergency treatment was administered throughout the study period; | — |
Countries
China
Contacts
Qilu Hospital of Shandong University