MedTrace Logo

Comparative Efficacy and Safety if Intravesical Botulinum Toxin A Versus Platelet-Rich Plasma in the Management of Refractory Overactive Bladder : A 2 Year Study

NCT07693192 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-09

No results posted yet for this study

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. 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.

Conditions

Interventions

PROCEDURE

Intravesical Botulinum Toxin A (100U)

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.

PROCEDURE

Intravesical Platelet-Rich Plasma

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.

Sponsors & Collaborators

  • Mahmoud Mohamed Farag Ali

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-12-01
Completion
2026-12-30

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07693192 on ClinicalTrials.gov