Submucosal Intravesical Injection of Platelet-rich Plasma in the Treatment of Painful Bladder Syndrome

NCT06209008 | Completed Phase 3 DMC

• 1 other identifier: Intravesical injections 001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Painful Bladder Syndrome (PBS); Interstitial Cystitis

Keywords

Platlet Rich Plasma; Intersticial cystitis; Endoscopic Management; Painful bladder syndrome

Outcome Measures

Primary Outcomes (2)

• 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 and improved if there is improvement in the GRA by =1

  at 1, 3, 6 months

• Visual Analogue Scale (VAS)

  Visual analogue scale is a uni-dimensional measure of pain intensity, used to record patient's pain progression, or compare pain severity between patients with similar conditions. We used a straight horizontal line of fixed length (100 mm), divided into 5 points starting from 0. No pain, 1. Slight discomfort, 2. Bearable pain, 3. Strong Pain and 4. Agonizing unbearable pain. The result was considered as excellent when patients reported no bladder pain (VAS = 0). The outcome was considered improved if pain VAS score reduced by 2 points on the scale.

  1, 3, 6 months

Secondary Outcomes (2)

• Macroscopic hematuria

  first postoperative day

• urinary tract infection

  after hospital discharge by 48 hours.

Study Arms (1)

Intravesical PRP injection

EXPERIMENTAL

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.

Drug: Intravesical injection of Platlet Rich Plasma (PRP)

Interventions

Intravesical injection of Platlet Rich Plasma (PRP) DRUG

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.

Also known as: PRP intradetrouser injection

Intravesical PRP injection

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Demerdash hospital, Faculty of medicine, Ain Shams University

Cairo, Abbassia, 1181, Egypt

Location

Related Publications (4)

• 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.

  PMID: 17900797 BACKGROUND

• 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.

  PMID: 31073635 BACKGROUND

• 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.

  PMID: 25623737 BACKGROUND

• 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.

  PMID: 29442539 BACKGROUND

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ahmed T Hassan, Assisstant Professor

  AinShams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 17, 2024
• Study Start: April 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)