Bladder Pain Syndrome, Interstitial Cystitis, Platelet Enriched Plasma
Conditions
Brief summary
A prospective randomized trial will be conducted aiming at evaluation the efficacy and safety of platelet enriched plasma for management of bladder pain syndrome .
Interventions
BIOLOGICALplatelet enriched plasma
PRP is prepared via a two-step centrifugation preparation of a blood sample, which is cured with an anticoagulant. Then either with be applied through urethral catheter in one arm or via submucos injection in anther one.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with diagnosis of Interstitial cystitis/ Bladder pain syndrome
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of interstitial cystitis/ Bladder painful Syndrome for more than 3 months will be enrolled
Exclusion criteria
* Patients with Anemia, blood disorders, history of pelvic irradiation, pelvic malignancy, and active urinary tract infection unless treated, vesical stone, gynecological disorders e.g. uterine fibroid and neurological disorders will be excluded. Patients less than 18 years old will not be allowed to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy as measured by global response assessment GRA | 3 month for each case. Expected time about 18-24 months for whole study period | It will be measured by global response assessment as main tool. Other measurable outcomes including visual analogue scale for pain, Interstitial Cystitis Symptom Index (4 questions) and Problem Index (4 questions) (ICSI/ICPI). These measures will be collected after each session during period of administration of treatment then at 3 months after end of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety : rate of complication and grade of complications graded by Dindo-Clavien classification | 3 month for each case. Expected time about 18-24 months for whole study period | patients will be asked and observed for any anticipated adverse events as hematuria, dysurea, any drug reaction. They will be kept for observation in hospital for 4 hours after delivery for treatment. Periodic reporting of any adverse event by phone call or during next visit. |
| incidence of urinary tract infection and gynecological infection among this group | 3 month for each case. Expected time about 18-24 months for whole study period | by doing urine analysis+/- culture if indicated. By doing vaginal swap for culture if indicated |
Countries
Egypt
Contacts
Primary ContactAhmed S El Hefnawy, MD
Backup ContactMohamed Attia
Outcome results
None listed