Detrusor Overactivity, Overactive Bladder Syndrome, Urinary Urge Incontinence
Conditions
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
Brief 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. 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.
Interventions
BIOLOGICALPlatelet-Rich Plasma
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.
DRUGIntravesical Botulinum Toxin Injection
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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The study is single-blinded. The outcome assessors who evaluate bladder diaries, questionnaires, and urodynamic tests will be blinded to treatment assignment. Participants and treating physicians will be aware of the intervention due to differences in preparation and administration.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overactive Bladder Symptom Score (OABSS) from baseline | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Consultation on Incontinence Questionnaire-Overactive Bladder (ICIQ-OAB) score from baseline | Baseline, 3 months, 6 months, 9 months, and 12 months after intervention | 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. |
| Incidence of urinary tract infection after intervention | Up to 12 months 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. |
| Incidence of urinary retention requiring catheterization | Up to 12 months after intervention | 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. |
| Incidence of hematuria following intervention | Within 7 days of 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. |
Countries
Egypt
Contacts
Primary ContactTamer A Diab, MD
Outcome results
None listed