Status:
COMPLETED
Submucosal Intravesical Injection of Platelet-rich Plasma in the Treatment of Painful Bladder Syndrome
Lead Sponsor:
Ain Shams University
Conditions:
Painful Bladder Syndrome (PBS)
Interstitial Cystitis
Eligibility:
All Genders
30-50 years
Phase:
PHASE3
Brief Summary
Interstitial cystitis/painful bladder syndrome (IC/PBS) is characterized by a constellation of bladder symptoms, including urinary frequency, urgency, nocturia, and pelvic pain. Current intravesical ...
Detailed Description
A Prospective clinical trial to assess the effectiveness of submucosal intravesical injection of autologous platelet-rich plasma in the treatment of IC/PBS resistant to conventional methods of treatme...
Eligibility Criteria
Inclusion
- History of symptoms of bladder pain/discomfort related to bladder filling and accompanied by other symptoms such as frequency and urgency.
- The symptoms are lasting for not less than 6 months.
- Failed medical treatment in the form of IC/PBS symptoms not relieved by antimicrobials, anticholinergics or antispasmodics after 6 months.
Exclusion
- Pregnancy or lactation.
- Prior therapy with intravesical treatment.
- Incomplete medical therapy (Receiving therapy for \<3 months with antidepressants, anti-histaminics, hormonal agonists or antagonists).
- Previous bladder or pelvic surgery or procedure having affected the bladder function.
- Urodynamic study showing detrusor overactivity.
- Elevated serum Prostatic Specific Antigen (PSA) level in males
- Other causes of IC/PBS symptoms including :
- i) Urinary bladder malignancy: bladder masses shown by ultrasonography or malignant cells by urine cytology.
- ii) Indwelling catheters. iii) Infection: urinary tract infection, sexually transmitted disease and vaginitis.
- iv) Chronic bacterial prostatitis. v) Chemical, tuberculous or radiation cystitis. vi) Bladder or lower ureteral calculi by non-contrast computed tomography (CT). vii) Pelvic organ prolapse (POP) by POP-Q assessment system. viii) Bladder outlet obstruction (BOO) diagnosed by urodynamic study.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06209008
Start Date
April 1 2021
End Date
December 1 2023
Last Update
January 17 2024
Active Locations (1)
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1
Demerdash hospital, Faculty of medicine, Ain Shams University
Cairo, Abbassia, Egypt, 1181