Painful Bladder Syndrome (PBS)Phase 3PRPNCT06209008
Submucosal Intravesical Injection of Platelet-rich Plasma in the Treatment of Painful Bladder Syndrome
A Phase 3 study testing Intravesical injection of Platlet Rich Plasma (PRP) in people with Painful Bladder Syndrome (PBS) and Interstitial Cystitis, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Painful Bladder Syndrome (PBS), Interstitial Cystitis
- What is being tested?
- Intravesical injection of Platlet Rich Plasma (PRP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 1 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Other causes of IC/PBS symptoms including :
- Urinary bladder malignancy: bladder masses shown by ultrasonography or malignant cells by urine cytology.
- Indwelling catheters. iii) Infection: urinary tract infection, sexually transmitted disease and vaginitis.
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Demerdash hospital, Faculty of medicine, Ain Shams University
Cairo, Abbassia, 1181
About this study
Official title: 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.
Read the 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.
- Being tested
- Intravesical injection of Platlet Rich Plasma (PRP)
- Keywords
- Platlet Rich Plasma, Intersticial cystitis, Endoscopic Management, Painful bladder syndrome
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravesical injection of Platlet Rich Plasma (PRP)Drug
Also called PRP intradetrouser 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Intravesical injection of Platlet Rich Plasma (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 1, 3, 6 months
Secondary outcomes (2)
Macroscopic hematuria
Presence of more than 100 Red blood cells (RBC's) / High power field (HPF) in urine analysis
Measured: first postoperative day
urinary tract infection
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.
Measured: after hospital discharge by 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Apr 2021
- Primary completion1 Apr 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Painful Bladder Syndrome (PBS)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younan Ramsis, Ain Shams University
- Investigators
- Ahmed T Hassan, Assisstant Professor, Study director, AinShams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209008
- Sponsor's protocol ID
- Intravesical injections 001
- Acronym
- PRP
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17900797Pape 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.
PubMed 31073635Hanno 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.
PubMed 25623737Etulain 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.
PubMed 29442539
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Submucosal Intravesical Injection of Platelet-rich Plasma in the Treatment of Interstitial Cystitis/Painful Bladder Syndrome
- ClinicalTrials.gov ID
- NCT06209008
- Acronym / sponsor ID
- PRP / Intravesical injections 001
- Keywords
- Platlet Rich Plasma, Intersticial cystitis, Endoscopic Management, Painful bladder syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravesical PRP injection | Experimental | 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. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravesical injection of Platlet Rich Plasma (PRP)Also: PRP intradetrouser injectionPatients 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 PRP injection |
Primary outcome
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
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.
2 secondary outcomes
Macroscopic hematuria
Time frame: first postoperative day
urinary tract infection
Time frame: after hospital discharge by 48 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Background: PubMed 17900797van 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.
- Background: PubMed 31073635Pape 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.
- Background: PubMed 25623737Hanno 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.
- Background: PubMed 29442539Etulain 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed T Hassan, Assisstant Professor study director
AinShams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravesical injection of Platlet Rich Plasma (PRP) in people with Painful Bladder Syndrome (PBS) and Interstitial Cystitis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Response Assessment (GRA) at 6 months after the PRP injection. (time frame: at 1, 3, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06209008, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.