Clinical trial NCT06209008: Submucosal Intravesical Injection of Platelet-rich Plasma in the Treatment of Painful Bladder Syndrome
Official title: Efficacy and Safety of Submucosal Intravesical Injection of Platelet-rich Plasma in the Treatment of Interstitial Cystitis/Painful Bladder Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Painful Bladder Syndrome (PBS)
Interstitial Cystitis
Keywords: Platlet Rich Plasma
Intersticial cystitis
Endoscopic Management
Painful bladder syndrome
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. History of symptoms of bladder pain/discomfort related to bladder filling and accompanied by other symptoms such as frequency and urgency.
2. The symptoms are lasting for not less than 6 months.
3. Failed medical treatment in the form of IC/PBS symptoms not relieved by antimicrobials, anticholinergics or antispasmodics after 6 months.

Exclusion Criteria:

1. Pregnancy or lactation.
2. Prior therapy with intravesical treatment.
3. Incomplete medical therapy (Receiving therapy for \<3 months with antidepressants, anti-histaminics, hormonal agonists or antagonists).
4. Previous bladder or pelvic surgery or procedure having affected the bladder function.
5. Urodynamic study showing detrusor overactivity.
6. Elevated serum Prostatic Specific Antigen (PSA) level in males
7. 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.

Primary outcomes:
measure: Global Response Assessment (GRA) at 6 months after the PRP injection.
timeFrame: at 1, 3, 6 months
measure: Visual Analogue Scale (VAS)
timeFrame: 1, 3, 6 months
Secondary outcomes:
measure: Macroscopic hematuria
timeFrame: first postoperative day
measure: urinary tract infection
timeFrame: after hospital discharge by 48 hours.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Demerdash hospital, Faculty of medicine, Ain Shams University
state: Abbassia
Study officials:
affiliation: AinShams University
name: Ahmed T Hassan, Assisstant Professor
role: STUDY_DIRECTOR
References:
citation: van de Merwe JP, Nordling J, Bouchelouche P, Bouchelouche K, Cervigni M, Daha LK, Elneil S, Fall M, Hohlbrugger G, Irwin P, Mortensen S, van Ophoven A, Osborne JL, Peeker R, Richter B, Riedl C, Sairanen J, Tinzl M, Wyndaele JJ. Diagnostic criteria, classification, and nomenclature for painful bladder syndrome/interstitial cystitis: an ESSIC proposal. Eur Urol. 2008 Jan;53(1):60-7. doi: 10.1016/j.eururo.2007.09.019. Epub 2007 Sep 20.
citation: Pape J, Falconi G, De Mattos Lourenco TR, Doumouchtsis SK, Betschart C. Variations in bladder pain syndrome/interstitial cystitis (IC) definitions, pathogenesis, diagnostics and treatment: a systematic review and evaluation of national and international guidelines. Int Urogynecol J. 2019 Nov;30(11):1795-1805. doi: 10.1007/s00192-019-03970-5. Epub 2019 May 9.
citation: Hanno PM, Erickson D, Moldwin R, Faraday MM; American Urological Association. Diagnosis and treatment of interstitial cystitis/bladder pain syndrome: AUA guideline amendment. J Urol. 2015 May;193(5):1545-53. doi: 10.1016/j.juro.2015.01.086. Epub 2015 Jan 23.
citation: Etulain J. Platelets in wound healing and regenerative medicine. Platelets. 2018 Sep;29(6):556-568. doi: 10.1080/09537104.2018.1430357. Epub 2018 Feb 14.