Overactive Bladder SyndromeNCT07184307
Platelet-Rich Plasma Versus Botulinum Toxin for Refractory Overactive Bladder: A Randomized Trial
A study testing Platelet-Rich Plasma and Intravesical Botulinum Toxin Injection in people with Overactive Bladder Syndrome and Urinary Urge Incontinence, run by Benha University at 1 site in Egypt.
Trial summary
Overactive bladder is a common condition that causes sudden urges to urinate, frequent urination, night-time urination, and sometimes leakage of urine. Many people with overactive bladder improve with lifestyle changes and medicines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder Syndrome, Urinary Urge Incontinence, Detrusor Overactivity
- What is being tested?
- Platelet-Rich Plasma and Intravesical Botulinum Toxin Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2025to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- History of urgency, frequency, nocturia, with or without urge urinary incontinence, lasting for at least 6 months
- Failure of standard medical treatment (antimuscarinics, beta-3 adrenergic agonists, or other appropriate therapy) for at least 6 months
- Willing and able to complete bladder diaries, questionnaires, and urodynamic testing
- Provides informed consent
Who cannot join
- Pregnancy or lactation
- Previous intravesical biological therapy (e.g., platelet-rich plasma or botulinum toxin)
- Prior pelvic or bladder surgery that may affect bladder function
- Active urinary tract infection or sexually transmitted infection
- Vaginitis or chronic bacterial prostatitis
- Bladder or lower ureteral stones confirmed by imaging
Show all 11Show fewer
- Bladder outlet obstruction on urodynamic study
- Bladder malignancy (mass on imaging or malignant cells on cytology)
- Use of indwelling urinary catheter
- Severe uncontrolled medical conditions (e.g., uncontrolled diabetes, advanced renal or hepatic impairment)
- Known hypersensitivity to botulinum toxin or contraindication to platelet-rich plasma preparation (e.g., coagulopathy, inability to discontinue anticoagulation safely)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Benha University Hospital, Faculty of Medicine, Department of Urology
Banhā, Qalyubia Governorate, 13511
Tamer A Diab, MD, 01003583264 ext. +2, Tamer.diab@fmed.bu.edu.eg
About this study
Official title: Intra-vesical Injection of Platelet-Rich Plasma Compared With Botox for Management of Patients With Refractory Overactive Bladder: A Comparative Randomized Study
Overactive bladder is a common condition that causes sudden urges to urinate, frequent urination, night-time urination, and sometimes leakage of urine. Many people with overactive bladder improve with lifestyle changes and medicines. However, some patients do not respond to these standard treatments and continue to suffer from bothersome symptoms. This study is designed to help patients who have not improved with available medical therapy.
Two treatments will be compared in this research. The first treatment uses platelet-rich plasma. Platelet-rich plasma is made from a patient's own blood and contains growth factors that may help repair the lining of the bladder and improve bladder function. The second treatment uses botulinum toxin. Botulinum toxin is a protein that can reduce unwanted bladder contractions and is already approved for use in patients with overactive bladder who did not respond to other treatments.
Read more
The purpose of this study is to evaluate whether platelet-rich plasma injection into the bladder wall is safe, effective, and durable when compared with botulinum toxin injection into the bladder muscle. We believe that platelet-rich plasma may improve bladder health by encouraging tissue repair and reducing inflammation, while botulinum toxin may reduce bladder overactivity by blocking chemical signals that cause muscle contractions.
This study will take place at Benha University Hospital in Egypt. About 48 adult participants with overactive bladder that has not improved after at least six months of medical therapy will be enrolled. Participants will be randomly assigned to one of two groups. One group will receive platelet-rich plasma injections into the bladder lining, and the other group will receive botulinum toxin injections into the bladder muscle. The procedures will be performed under anesthesia using a cystoscope, which is a thin instrument inserted into the bladder.
Participants will be followed for one year. At several time points during follow-up, they will complete bladder symptom questionnaires, keep a voiding diary, and undergo urodynamic studies to measure bladder capacity and function. Researchers will also monitor safety by recording any side effects, such as urinary tract infections or temporary difficulty emptying the bladder.
The main goal of this study is to determine whether platelet-rich plasma can reduce symptoms of overactive bladder as effectively as botulinum toxin, with fewer side effects and longer-lasting results. If successful, platelet-rich plasma could offer a new treatment option for patients who continue to struggle with overactive bladder despite standard medical therapy.
- Being tested
- Platelet-Rich Plasma, Intravesical Botulinum Toxin Injection
- Keywords
- Platelet-Rich Plasma, Botulinum Toxin Type A, Overactive Bladder, Refractory Overactive Bladder, Urinary Urgency, Urinary Frequency, Urge Urinary Incontinence, Detrusor Overactivity, Intravesical Injection, Regenerative Therapy
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich PlasmaBiological
Autologous platelet-rich plasma prepared from approximately 50 milliliters of venous blood using a two-step centrifugation protocol. Ten milliliters of platelet-rich plasma are obtained and injected into the sub-urothelial layer of the bladder wall during cystoscopy under anesthesia.
Intravesical Botulinum Toxin InjectionDrug
Botulinum toxin (100 units) reconstituted in 10 milliliters of saline and injected into the bladder detrusor muscle at multiple sites under cystoscopic guidance, sparing the trigone.
| Study group | Role | What they receive |
|---|---|---|
| Platelet-Rich Plasma Injection | Experimental | Participants will receive intravesical platelet-rich plasma prepared from their own blood. Approximately 50 milliliters of venous blood will be processed with a two-step centrifugation protocol to concentrate platelets. Ten milliliters of platelet-rich plasma will be injected sub-urothelially at 20 sites (0.5 milliliters per site) in the posterior and lateral bladder walls under cystoscopic guidance with spinal or general anesthesia. A 16-French urethral catheter will be left overnight. A short oral antibiotic course will be given for three days. Receives: Biological: Platelet-Rich Plasma |
| Botulinum Toxin Injection | Active comparator | Participants will receive intravesical injection of onabotulinumtoxinA. One hundred units of onabotulinumtoxinA will be reconstituted in 10 milliliters of saline and injected into the bladder detrusor muscle at 20 sites (0.5 milliliters per site), sparing the trigone, under cystoscopic guidance with spinal or general anesthesia. A 16-French urethral catheter will be left overnight. A short oral antibiotic course will be given for three days. Receives: Drug: Intravesical Botulinum Toxin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Overactive Bladder Symptom Score (OABSS) from baseline
The Overactive Bladder Symptom Score (OABSS) is a patient-reported questionnaire with 4 items: daytime frequency (0-2), night-time frequency (0-3), urgency (0-5), and urge urinary incontinence (0-5). The total score ranges from 0 to 15, with higher scores indicating more severe symptoms. The outcome measure is the change in total OABSS score from baseline to follow-up.
Measured: Baseline and 6 months after intervention
Change in Maximum Cystometric Capacity (MCC) from baseline
Maximum cystometric capacity (MCC) is measured during urodynamic testing as the bladder volume at which the patient can no longer delay urination, experiences strong desire to void, or involuntary detrusor contractions occur. Higher values indicate improved bladder storage capacity. The outcome measure is the change in MCC (in milliliters) from baseline to follow-up.
Measured: Baseline and 6 months after intervention
Secondary outcomes (4)
Change in International Consultation on Incontinence Questionnaire-Overactive Bladder (ICIQ-OAB) score from baseline
The ICIQ-OAB is a validated questionnaire assessing frequency, nocturia, urgency, and urge urinary incontinence. Each item is scored from 0 to 4, with a total score range of 0-16. Higher scores indicate worse symptoms. The outcome measure is the change in total ICIQ-OAB score from baseline to follow-up.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months after intervention
Incidence of urinary tract infection after intervention
Culture-proven urinary tract infection identified during follow-up visits or patient-reported symptoms confirmed with laboratory testing. Outcome measure is the number and proportion of participants experiencing at least one urinary tract infection.
Measured: Up to 12 months after intervention
Incidence of urinary retention requiring catheterization
Post-procedure urinary retention defined as inability to void with post-void residual volume greater than 300 milliliters, requiring temporary catheterization. Outcome measure is the number and proportion of participants who develop urinary retention.
Measured: Up to 12 months after intervention
Incidence of hematuria following intervention
Visible or microscopic hematuria documented within 7 days of the procedure. Outcome measure is the number and proportion of participants with procedure-related hematuria.
Measured: Within 7 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start15 Apr 2025
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either sub-urothelial platelet-rich plasma injections or intradetrusor botulinum toxin injections.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Abd El-Wahab Diab, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184307
- Sponsor's protocol ID
- MD: 8-19-2026
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including baseline characteristics, outcome measures, and safety data, will be made available to other qualified researchers for secondary analyses. Personal identifiers will be removed prior to sharing.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-vesical Injection of Platelet-Rich Plasma Compared With Botox for Management of Patients With Refractory Overactive Bladder: A Comparative Randomized Study
- ClinicalTrials.gov ID
- NCT07184307
- Acronym / sponsor ID
- MD: 8-19-2026
- Keywords
- Platelet-Rich Plasma, Botulinum Toxin Type A, Overactive Bladder, Refractory Overactive Bladder, Urinary Urgency, Urinary Frequency, Urge Urinary Incontinence, Detrusor Overactivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 19 Sep 2025 (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.
Overactive bladder is a common condition that causes sudden urges to urinate, frequent urination, night-time urination, and sometimes leakage of urine. Many people with overactive bladder improve with lifestyle changes and medicines. However, some patients do not respond to these standard treatments and continue to suffer from bothersome symptoms. This study is designed to help patients who have not improved with available medical therapy.
Two treatments will be compared in this research. The first treatment uses platelet-rich plasma. Platelet-rich plasma is made from a patient's own blood and contains growth factors that may help repair the lining of the bladder and improve bladder function. The second treatment uses botulinum toxin. Botulinum toxin is a protein that can reduce unwanted bladder contractions and is already approved for use in patients with overactive bladder who did not respond to other treatments.
The purpose of this study is to evaluate whether platelet-rich plasma injection into the bladder wall is safe, effective, and durable when compared with botulinum toxin injection into the bladder muscle. We believe that platelet-rich plasma may improve bladder health by encouraging tissue repair and reducing inflammation, while botulinum toxin may reduce bladder overactivity by blocking chemical signals that cause muscle contractions.
This study will take place at Benha University Hospital in Egypt. About 48 adult participants with overactive bladder that has not improved after at least six months of medical therapy will be enrolled. Participants will be randomly assigned to one of two groups. One group will receive platelet-rich plasma injections into the bladder lining, and the other group will receive botulinum toxin injections into the bladder muscle. The procedures will be performed under anesthesia using a cystoscope, which is a thin instrument inserted into the bladder.
Participants will be followed for one year. At several time points during follow-up, they will complete bladder symptom questionnaires, keep a voiding diary, and undergo urodynamic studies to measure bladder capacity and function. Researchers will also monitor safety by recording any side effects, such as urinary tract infections or temporary difficulty emptying the bladder.
The main goal of this study is to determine whether platelet-rich plasma can reduce symptoms of overactive bladder as effectively as botulinum toxin, with fewer side effects and longer-lasting results. If successful, platelet-rich plasma could offer a new treatment option for patients who continue to struggle with overactive bladder despite standard medical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either sub-urothelial platelet-rich plasma injections or intradetrusor botulinum toxin injections.
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich Plasma Injection | Experimental | Biological: Platelet-Rich PlasmaParticipants will receive intravesical platelet-rich plasma prepared from their own blood. Approximately 50 milliliters of venous blood will be processed with a two-step centrifugation protocol to concentrate platelets. Ten milliliters of platelet-rich plasma will be injected sub-urothelially at 20 sites (0.5 milliliters per site) in the posterior and lateral bladder walls under cystoscopic guidance with spinal or general anesthesia. A 16-French urethral catheter will be left overnight. A short oral antibiotic course will be given for three days. |
| Botulinum Toxin Injection | Active comparator | Drug: Intravesical Botulinum Toxin InjectionParticipants will receive intravesical injection of onabotulinumtoxinA. One hundred units of onabotulinumtoxinA will be reconstituted in 10 milliliters of saline and injected into the bladder detrusor muscle at 20 sites (0.5 milliliters per site), sparing the trigone, under cystoscopic guidance with spinal or general anesthesia. A 16-French urethral catheter will be left overnight. A short oral antibiotic course will be given for three days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- History of urgency, frequency, nocturia, with or without urge urinary incontinence, lasting for at least 6 months
- Failure of standard medical treatment (antimuscarinics, beta-3 adrenergic agonists, or other appropriate therapy) for at least 6 months
- Willing and able to complete bladder diaries, questionnaires, and urodynamic testing
- Provides informed consent
Key exclusion criteria (11 listed)
- Pregnancy or lactation
- Previous intravesical biological therapy (e.g., platelet-rich plasma or botulinum toxin)
- Prior pelvic or bladder surgery that may affect bladder function
- Active urinary tract infection or sexually transmitted infection
- Vaginitis or chronic bacterial prostatitis
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 |
|---|---|---|
| Platelet-Rich PlasmaAutologous platelet-rich plasma prepared from approximately 50 milliliters of venous blood using a two-step centrifugation protocol. Ten milliliters of platelet-rich plasma are obtained and injected into the sub-urothelial layer of the bladder wall during cystoscopy under anesthesia. | Biological | Platelet-Rich Plasma Injection |
| Intravesical Botulinum Toxin InjectionBotulinum toxin (100 units) reconstituted in 10 milliliters of saline and injected into the bladder detrusor muscle at multiple sites under cystoscopic guidance, sparing the trigone. | Drug | Botulinum Toxin Injection |
Primary outcome
Change in Overactive Bladder Symptom Score (OABSS) from baseline
Time frame: Baseline and 6 months after intervention
The Overactive Bladder Symptom Score (OABSS) is a patient-reported questionnaire with 4 items: daytime frequency (0-2), night-time frequency (0-3), urgency (0-5), and urge urinary incontinence (0-5). The total score ranges from 0 to 15, with higher scores indicating more severe symptoms. The outcome measure is the change in total OABSS score from baseline to follow-up.
Change in Maximum Cystometric Capacity (MCC) from baseline
Time frame: Baseline and 6 months after intervention
Maximum cystometric capacity (MCC) is measured during urodynamic testing as the bladder volume at which the patient can no longer delay urination, experiences strong desire to void, or involuntary detrusor contractions occur. Higher values indicate improved bladder storage capacity. The outcome measure is the change in MCC (in milliliters) from baseline to follow-up.
4 secondary outcomes
Change in International Consultation on Incontinence Questionnaire-Overactive Bladder (ICIQ-OAB) score from baseline
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months after intervention
Incidence of urinary tract infection after intervention
Time frame: Up to 12 months after intervention
Incidence of urinary retention requiring catheterization
Time frame: Up to 12 months after intervention
Incidence of hematuria following intervention
Time frame: Within 7 days of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including baseline characteristics, outcome measures, and safety data, will be made available to other qualified researchers for secondary analyses. Personal identifiers will be removed prior to sharing.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-Rich Plasma and Intravesical Botulinum Toxin Injection in people with Overactive Bladder Syndrome and Urinary Urge Incontinence, run by Benha 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 19 Sep 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tamer A Diab, MD (01003583264 ext. +2, Tamer.diab@fmed.bu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Overactive Bladder Symptom Score (OABSS) from baseline (time frame: Baseline and 6 months after intervention). 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?
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 19 Sep 2025; AzTrials last refreshed its copy on 31 Oct 2026.