Interstitial cystitis/bladder pain syndrome (IC/BPS) Urological and Genital Diseases
Conditions
Interventions
Women with IC/BPS were randomly assigned to a pressure- and volume-controlled balloon dilation group (experimental group, n = 25) or a traditional bladder hydrodistension group (control group, n = 25)
Sponsors
Dalian Friendship Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. The diagnosis of IC was based on internationally recognised diagnostic criteria 2. The age range of participants was 18 to 80 years 3. Participants were required to have the ability to comprehend and adhere to study requirements, including completion of all necessary assessments and tests
Exclusion criteria
Exclusion criteria: 1. Severe heart, liver or kidney disease 2. Currently undergoing treatment or taking medication that might interfere with the study results 3. Mental illness or cognitive impairment that could affect their understanding of the research 4. Pregnant or lactating women 5. Previously undergone bladder dilatation or related surgeries 6. A history of allergies to drugs or materials used in the procedure 7. Active autoimmune diseases or other conditions affecting the immune system 8. Recent use of anticoagulants within the past 3 months constituted an exclusion criterion 9. Experiencing severe psychosocial problems, such as major depression or suicidal tendencies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pelvic pain and urinary frequency measured using the O'Leary-Sant Interstitial Cystitis Symptom and Problem Index questionnaire at baseline, 2 weeks, 1 month, 2 months, 3 months, and 6 months post-treatment. 2. Pelvic pain and urinary frequency measured using the pelvic pain and urinary frequency (PUF) questionnaire at baseline, 2 weeks, 1 month, 2 months, 3 months, and 6 months post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maximum voided volume (MVV) measured using a 24-hour bladder diary at baseline, 2 weeks, 1 month, 2 months, 3 months, and 6 months post-treatment 2. Bladder capacity ratio (pre-/post-dilation) measured using cystoscopic volume assessment at 6 months post-treatment 3. Nocturia episodes measured using patient-reported sleep logs at baseline, 2 weeks, 1 month, 2 months, 3 months, and 6 months post-treatment 4. Postoperative complications (bleeding, bladder rupture) recorded via clinical documentation at 2 weeks and 6 months post-treatment 5. Treatment satisfaction measured using a 5-point Likert scale questionnaire (developed by the study team) at 6 months post-treatment | — |
Countries
China
Contacts
Public ContactJinyi Yang
Outcome results
None listed