A prospective randomized trial will be conducted aiming at evaluation the efficacy and safety of platelet enriched plasma for management of bladder pain syndrome .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
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.
Ahmed S EL Hefnawy
Al Mansurah, Egypt
RECRUITINGefficacy as measured by global response assessment "GRA"
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
Time frame: 3 month for each case. Expected time about 18-24 months for whole study period
safety : rate of complication and grade of complications graded by Dindo-Clavien classification
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.
Time frame: 3 month for each case. Expected time about 18-24 months for whole study period
incidence of urinary tract infection and gynecological infection among this group
by doing urine analysis+/- culture if indicated. By doing vaginal swap for culture if indicated
Time frame: 3 month for each case. Expected time about 18-24 months for whole study period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.