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NCT Number: NCT07184307

Platelet-Rich Plasma Versus Botulinum Toxin for Refractory Overactive Bladder: A Randomized Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospital, Faculty of Medicine, Department of Urology

Banhā, Qalyubia Governorate, 13511, Egypt

Location status: Recruiting

Location contact

Tamer A Diab, MD

CONTACT

[email protected]

01003583264 ext. +2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Platelet-Rich Plasma

Biological

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 Injection

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

    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.

  2. Incidence of urinary tract infection after intervention

    Time frame: 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.

  3. Incidence of urinary retention requiring catheterization

    Time frame: 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.

  4. Incidence of hematuria following intervention

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tamer A Diab, MD

CONTACT

[email protected]

01003583264 ext. +2

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Intra-vesical Injection of Platelet-Rich Plasma Compared With Botox for Management of Patients With Refractory Overactive Bladder: A Comparative Randomized Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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