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A prospective randomized trial will be conducted aiming at evaluation the efficacy and safety of platelet enriched plasma for management of bladder pain syndrome .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravesical instillation | Active Comparator | Intravesical instillation of platelet enriched plasma every week for 6 weeks |
|
| submucosal injection | Active Comparator | submucosal injectionof platelet enriched plasma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| platelet enriched plasma | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy 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 | 3 month for each case. Expected time about 18-24 months for whole study period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 month for each case. Expected time about 18-24 months for whole study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed S El Hefnawy, MD | Contact | 01224285870 | a_s_elhefnawy@yahoo.com | |
| Mohamed Attia | Contact | 00201090988587 | drmohamedattya4@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed El Hefnawy, Msc, MD | Assistant professor of urology .Mansoura Urology and Nephrology Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahmed S EL Hefnawy | Recruiting | Al Mansurah | Egypt |
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Patients with diagnosis of Interstitial cystitis/ Bladder pain syndrome
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| 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 | 3 month for each case. Expected time about 18-24 months for whole study period |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |