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

January 13, 2024 updated by: Younan Ramsis, Ain Shams University

Efficacy and Safety of Submucosal Intravesical Injection of Platelet-rich Plasma in the Treatment of Interstitial Cystitis/Painful Bladder Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbassia
      • Cairo, Abbassia, Egypt, 1181
        • Demerdash Hospital, Faculty of Medicine, Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravesical PRP injection
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)
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 Names:
  • PRP intradetrouser injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Response Assessment (GRA) at 6 months after the PRP injection.
Time Frame: at 1, 3, 6 months
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)
Time Frame: 1, 3, 6 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Macroscopic hematuria
Time Frame: first postoperative day
Presence of more than 100 Red blood cells (RBC's) / High power field (HPF) in urine analysis
first postoperative day
urinary tract infection
Time Frame: after hospital discharge by 48 hours.
Doing a nitrate dipstick test that will de done after discharge by 48 hours, if negative indicates that there is no infection. If positive, it is an indication of the presence of UTI, then a culture and senstivity will be ordered and antibiotic prescribed according to it.
after hospital discharge by 48 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Ahmed T Hassan, Assisstant Professor, Ainshams university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 13, 2024

First Posted (Estimated)

January 17, 2024

Study Record Updates

Last Update Posted (Estimated)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 13, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Intravesical injections 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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