Overactive BladderNCT07693192
Comparative Efficacy and Safety if Intravesical Botulinum Toxin A Versus Platelet-Rich Plasma in the Management of Refractory Overactive Bladder : A 2 Year Study
A study testing Intravesical Botulinum Toxin A (100U) and Intravesical Platelet-Rich Plasma in people with Overactive Bladder, run by Mahmoud Mohamed Farag Ali at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the efficacy and safety of intravesical Botulinum Toxin A versus intravesical Platelet-Rich Plasma (PRP) in adults with refractory overactive bladder who have not responded adequately to conventional medical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Intravesical Botulinum Toxin A (100U) and Intravesical Platelet-Rich Plasma
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 30 Dec 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
- Adults aged ≥18 years
- Diagnosis of refractory overactive bladder (OAB)
- Failed at least 2 pharmacological therapies
- Willing and able to provide informed consent
Who cannot join
- Neurogenic bladder
- Active urinary tract infection (UTI)
- Pregnancy or lactation
- Known allergy to botulinum toxin or any PRP components
- History of pelvic radiation or bladder malignancy
- Uncontrolled coagulopathy or bleeding disorder
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to compare the efficacy and safety of intravesical Botulinum Toxin A versus intravesical Platelet-Rich Plasma (PRP) in adults with refractory overactive bladder who have not responded adequately to conventional medical treatment. The main questions it aims to answer are:
- Whether intravesical PRP is as effective as intravesical Botulinum Toxin A in improving overactive bladder symptoms.
- Whether intravesical PRP has a better safety profile and lower incidence of adverse events during the 2-year follow-up period.
Read more
Researchers will compare participants receiving intravesical Botulinum Toxin A with those receiving intravesical PRP to determine differences in symptom improvement, quality of life, urodynamic outcomes, and treatment-related adverse events.
Participants will:
- Receive either intravesical Botulinum Toxin A injection or intravesical Platelet-Rich Plasma injection.
- Undergo baseline clinical assessment, symptom evaluation, and urodynamic studies as indicated.
- Attend scheduled follow-up visits over a 2-year period.
- Complete validated questionnaires assessing overactive bladder symptoms and quality of life.
- Be monitored for treatment efficacy and any adverse events throughout the study.
Read the detailed description
The purpose of this prospective randomized clinical trial is to compare the efficacy and safety of intravesical Platelet-Rich Plasma (PRP) injection with intravesical Botulinum Toxin A injection in adult patients with refractory overactive bladder (OAB) who have failed or were intolerant to conventional medical therapy. Overactive bladder is a chronic condition characterized by urinary urgency, usually accompanied by increased daytime frequency and nocturia, with or without urgency urinary incontinence, and has a significant negative impact on patients' quality of life.
Botulinum Toxin A is an established third-line treatment for refractory OAB; however, its use may be associated with adverse events such as urinary retention, increased post-void residual urine, and urinary tract infection. Platelet-Rich Plasma has recently emerged as a regenerative therapeutic option because of its anti-inflammatory and tissue-repair properties and may provide symptom improvement with fewer complications.
The primary objective of this study is to compare the improvement in overactive bladder symptoms between the two treatment groups over a 2-year follow-up period. Secondary objectives include comparing quality of life, urinary frequency, urgency episodes, urgency urinary incontinence episodes, nocturia, functional bladder capacity, post-void residual urine volume, patient satisfaction, durability of treatment response, and treatment-related adverse events.
Eligible participants will be randomly assigned to receive either intravesical Botulinum Toxin A injection or intravesical Platelet-Rich Plasma injection according to the study protocol. Baseline assessment will include medical history, physical examination, symptom evaluation using validated questionnaires, voiding diary, laboratory investigations, and other investigations as indicated. Participants will undergo scheduled follow-up visits throughout the 2-year study period to assess clinical response, monitor for adverse events, and evaluate the need for additional treatment.
- Conditions
- Overactive Bladder
- Being tested
- Intravesical Botulinum Toxin A (100U), Intravesical Platelet-Rich Plasma
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravesical Botulinum Toxin A (100U)Procedure or surgery
Also called Botox
Single intravesical injection of 100 units of Botulinum Toxin A (Botox) administered via cystoscopy under local or general anesthesia. The toxin is injected into 20-30 sites across the detrusor muscle, sparing the trigone. Patients are followed for efficacy and safety outcomes over 24 months.
Intravesical Platelet-Rich PlasmaProcedure or surgery
Also called PRP
Intravesical instillation of autologous platelet-rich plasma (PRP) prepared from patient's own blood, administered weekly for 3 consecutive sessions. Each session involves PRP instillation via urethral catheter, retained for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intravesical Botulinum Toxin A | Experimental | Participants in this arm will receive intravesical Botulinum Toxin A injection according to the study protocol and will be followed for 2 years to assess efficacy and safety outcomes. Receives: Procedure: Intravesical Botulinum Toxin A (100U) |
| Intravesical Platelet-Rich Plasma (PRP) | Experimental | Participants in this arm will receive intravesical Platelet-Rich Plasma (PRP) injection according to the study protocol and will be followed for 2 years to assess efficacy and safety outcomes. Receives: Procedure: Intravesical Platelet-Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Urgency Urinary Incontinence Episodes
Change from baseline in mean number of urgency urinary incontinence episodes per 24 hours, assessed by 3-day voiding diary at 3, 6, 12, and 24 months post-treatment.
Measured: Baseline, 3, 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Jun 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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 to one of two parallel treatment groups: intravesical Botulinum Toxin A or intravesical Platelet-Rich Plasma (PRP). Both groups will be followed for 2 years to compare efficacy and safety outcomes.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahmoud Mohamed Farag Ali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Mohamed Farag Ali, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693192
- Sponsor's protocol ID
- Rc.1.6.2026
- Status last verified
- Jun 2026
- First submitted
- 3 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy and Safety if Intravesical Botulinum Toxin A Versus Platelet-Rich Plasma in the Management of Refractory Overactive Bladder : A 2 Year Study
- ClinicalTrials.gov ID
- NCT07693192
- Acronym / sponsor ID
- Rc.1.6.2026
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mahmoud Mohamed Farag AliUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Jul 2026 (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.
The goal of this clinical trial is to compare the efficacy and safety of intravesical Botulinum Toxin A versus intravesical Platelet-Rich Plasma (PRP) in adults with refractory overactive bladder who have not responded adequately to conventional medical treatment. The main questions it aims to answer are:
- Whether intravesical PRP is as effective as intravesical Botulinum Toxin A in improving overactive bladder symptoms.
- Whether intravesical PRP has a better safety profile and lower incidence of adverse events during the 2-year follow-up period.
Researchers will compare participants receiving intravesical Botulinum Toxin A with those receiving intravesical PRP to determine differences in symptom improvement, quality of life, urodynamic outcomes, and treatment-related adverse events.
Participants will:
- Receive either intravesical Botulinum Toxin A injection or intravesical Platelet-Rich Plasma injection.
- Undergo baseline clinical assessment, symptom evaluation, and urodynamic studies as indicated.
- Attend scheduled follow-up visits over a 2-year period.
- Complete validated questionnaires assessing overactive bladder symptoms and quality of life.
- Be monitored for treatment efficacy and any adverse events throughout the study.
Detailed description
The purpose of this prospective randomized clinical trial is to compare the efficacy and safety of intravesical Platelet-Rich Plasma (PRP) injection with intravesical Botulinum Toxin A injection in adult patients with refractory overactive bladder (OAB) who have failed or were intolerant to conventional medical therapy. Overactive bladder is a chronic condition characterized by urinary urgency, usually accompanied by increased daytime frequency and nocturia, with or without urgency urinary incontinence, and has a significant negative impact on patients' quality of life.
Botulinum Toxin A is an established third-line treatment for refractory OAB; however, its use may be associated with adverse events such as urinary retention, increased post-void residual urine, and urinary tract infection. Platelet-Rich Plasma has recently emerged as a regenerative therapeutic option because of its anti-inflammatory and tissue-repair properties and may provide symptom improvement with fewer complications.
The primary objective of this study is to compare the improvement in overactive bladder symptoms between the two treatment groups over a 2-year follow-up period. Secondary objectives include comparing quality of life, urinary frequency, urgency episodes, urgency urinary incontinence episodes, nocturia, functional bladder capacity, post-void residual urine volume, patient satisfaction, durability of treatment response, and treatment-related adverse events.
Eligible participants will be randomly assigned to receive either intravesical Botulinum Toxin A injection or intravesical Platelet-Rich Plasma injection according to the study protocol. Baseline assessment will include medical history, physical examination, symptom evaluation using validated questionnaires, voiding diary, laboratory investigations, and other investigations as indicated. Participants will undergo scheduled follow-up visits throughout the 2-year study period to assess clinical response, monitor for adverse events, and evaluate the need for additional treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel treatment groups: intravesical Botulinum Toxin A or intravesical Platelet-Rich Plasma (PRP). Both groups will be followed for 2 years to compare efficacy and safety outcomes.
| Arm | Type | Receives |
|---|---|---|
| Intravesical Botulinum Toxin A | Experimental | Procedure: Intravesical Botulinum Toxin A (100U)Participants in this arm will receive intravesical Botulinum Toxin A injection according to the study protocol and will be followed for 2 years to assess efficacy and safety outcomes. |
| Intravesical Platelet-Rich Plasma (PRP) | Experimental | Procedure: Intravesical Platelet-Rich PlasmaParticipants in this arm will receive intravesical Platelet-Rich Plasma (PRP) injection according to the study protocol and will be followed for 2 years to assess efficacy and safety outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≥18 years
- Diagnosis of refractory overactive bladder (OAB)
- Failed at least 2 pharmacological therapies
- Willing and able to provide informed consent
Key exclusion criteria (6 listed)
- Neurogenic bladder
- Active urinary tract infection (UTI)
- Pregnancy or lactation
- Known allergy to botulinum toxin or any PRP components
- History of pelvic radiation or bladder malignancy
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 Botulinum Toxin A (100U)Also: BotoxSingle intravesical injection of 100 units of Botulinum Toxin A (Botox) administered via cystoscopy under local or general anesthesia. The toxin is injected into 20-30 sites across the detrusor muscle, sparing the trigone. Patients are followed for efficacy and safety outcomes over 24 months. | Procedure or surgery | Intravesical Botulinum Toxin A |
| Intravesical Platelet-Rich PlasmaAlso: PRPIntravesical instillation of autologous platelet-rich plasma (PRP) prepared from patient's own blood, administered weekly for 3 consecutive sessions. Each session involves PRP instillation via urethral catheter, retained for 30 minutes. | Procedure or surgery | Intravesical Platelet-Rich Plasma (PRP) |
Primary outcome
Reduction in Urgency Urinary Incontinence Episodes
Time frame: Baseline, 3, 6, 12, and 24 months
Change from baseline in mean number of urgency urinary incontinence episodes per 24 hours, assessed by 3-day voiding diary at 3, 6, 12, and 24 months post-treatment.
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 9 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravesical Botulinum Toxin A (100U) and Intravesical Platelet-Rich Plasma in people with Overactive Bladder, run by Mahmoud Mohamed Farag Ali 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. 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?
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?
Reduction in Urgency Urinary Incontinence Episodes (time frame: Baseline, 3, 6, 12, and 24 months). 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 9 Jul 2026.