Submucosal Intravesical Injection of Platelet-rich Plasma in the Treatment of Painful Bladder Syndrome
Condition: Painful Bladder Syndrome (PBS); Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial; Syndrome; Pain
Study type: Interventional
Phase: Phase 3

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 IC/PBS treatment strategies include substances injected submucosally
      such as botulinum toxin A (BoNTA), or installed intravesically such as bacillus
      Calmette-Guerin (BCG), resiniferatoxin (RTX), lidocaine, chondroitin sulfate (CS),
      oxybutynin, and pentosan polysulfate (PPS).

      Plasma Rich Protein (PRP) is rich in growth factors, such as platelet-derived growth factor,
      epidermal growth factor, and transforming growth factor. With the help of these growth
      factors the defective epithelium can undergo proliferation, differentiation, and wound
      healing.
    

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 treatment. It was held in the hospitals of Ain Shams University.

      after meeting inclusion and exclusion criteria and attaining the written consent from the
      patients, they were submitted to intravesical injection of PRP.

      All procedures were performed under spinal or general anaesthesia and all patients had
      received a third generation cephalosporin at the induction of anaesthesia.

      Patients received 20 submucosal injections of PRP solution, each injection site receives 0.5
      mL PRP. The injection needle was inserted about 1 mm into the at the posterior and lateral
      walls of the bladder, using a 23 gauge needle and 22 F rigid cystoscope.

      After the PRP was injected, a 16 Fr urethral Foley catheter was left for one night to monitor
      the urine colour and patients were discharged on the next day. Oral antibiotics were
      prescribed for 3 days.

      Patients were followed up in the outpatient clinic after one week with urine culture and then
      every month after the PRP treatment day. The results of Global Response Assessment (GRA), the
      O'Leary-Sant score and pain Visual Analogue Scale (VAS) were recorded at baseline, 1, 3 and 6
      months after the PRP treatment. The treatment outcome was assessed by the Global Response
      Assessment (GRA) at 6 months after the PRP injection. The GRA is a seven-point symmetric
      scale used with the following possible responses: markedly worse (-3), moderately worse (-2),
      slightly worse (-1), no change (0), slightly improved (+1), moderately improved (+2), and
      markedly improved (+3). The result was considered as excellent when patients reported
      improvement in the GRA by >2 or patients became free of bladder pain (VAS = 0). The outcome
      was considered improved if there is improvement in the GRA by =1 or the pain VAS score
      reduced by 2. Patients with excellent and improved results were considered as having
      successful treatment. Otherwise, the treatment was considered to have failed.

      Operative time measured in minutes after the induction of anaesthesia.

      Complications were recorded associated with the operation including:

        -  Macroscopic haematuria: detected on the 1st postoperative day.

        -  Urinary tract infection: detected either by postoperative fever or by positive urine
           culture collected 1 week postoperatively.
    

Intervention name(s): Intravesical injection of Platlet Rich Plasma (PRP)
Intervention type(s): Drug
Intervention description(s): Patients will receive 20 submucosal injections of PRP solution, each injection site receives 0.5 mL PRP. The injection needle will be inserted about 1 mm into the at the posterior and lateral walls of the bladder, using a 23 gauge needle and 22 F rigid cystoscope.
Other intervention name(s): PRP intradetrouser injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Platlet Rich Plasma; Intersticial cystitis; Endoscopic Management; Painful bladder syndrome