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Neurotoxin

20 Botox Injections for Overactive Bladder

Phase 4
Waitlist Available
Led By Catherine Matthews, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female gender
Have already decided to undergo intradetrusor Botox® injections for treatment of refractory overactive bladder.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks post procedure
Awards & highlights

Study Summary

This trial is testing whether 10 injections of Botox is less painful and just as effective as 20 injections for treating urge incontinence.

Eligible Conditions
  • Overactive Bladder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are a woman.
Select...
You have already planned to receive Botox injections in your bladder to treat overactive bladder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain
Secondary outcome measures
Difference in Mean Urge Incontinence Episodes
Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life
Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life
+2 more

Trial Design

2Treatment groups
Active Control
Group I: 20 Botox InjectionsActive Control1 Intervention
100 units of Botox® (onabotulinumtoxinA) will be combined with 20 cc of sterile saline for the purpose of 20 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone.
Group II: 10 Botox InjectionsActive Control1 Intervention
100 units of Botox® (onabotulinumtoxinA) will be combined with 10 cc of sterile saline for the purpose of 10 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,230 Previous Clinical Trials
1,001,712 Total Patients Enrolled
Catherine Matthews, MDPrincipal InvestigatorWake Forest University Health Sciences
6 Previous Clinical Trials
632 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any risk associated with receiving twenty doses of Botox?

"The safety of 20 Botox Injections has been assessed and given a rating of 3 due to its approval as part of Phase 4 clinical trials."

Answered by AI

To what extent are 20 Botox Injections utilized in medical treatments?

"Botox injections are a popular method of managing urinary incontinence. 20 Botox Injections can also treat other medical issues such as spinal cord injury, botulism, and overactive bladder syndrome (OABs)."

Answered by AI

Are participants over 25 years of age eligible for this experiment?

"Individuals aged 18 to 90 years old are being considered for this trial."

Answered by AI

What precedent has been set with regard to 20 Botox Injections in other clinical trials?

"As of now, 61 medical trials for 20 Botox Injections are being conducted with a significant portion in their third phase. Of these studies, most are based out of Farmington Hills, Michigan but have spread to 759 other locations as well."

Answered by AI

Are there any vacancies in this medical experiment for participants?

"As outlined on clinicaltrials.gov, this medical trial is currently enrolling participants. The research was initially made public on November 10th 2019 with the latest update taking place in August 23rd 2022."

Answered by AI

How many participants are receiving treatment as part of this research?

"Affirmative. According to the clinicaltrials.gov website, this medical research project is actively seeking participants and was last updated on August 23rd 2022; it originally posted on November 10th 2019. The study seeks 40 patients from two locations."

Answered by AI

What are the qualifications for enrolling in this clinical research trial?

"This clinical trial has 40 openings for female participants, aged 18-90 with an overactive detrusor. The enrollees must be willing to learn or have a care provider perform intermittent catheterization, accept Botox® injections as treatment for refractory OAB and understand that they need to complete the required questionnaires throughout their follow up sessions after giving informed consent."

Answered by AI
~8 spots leftby Mar 2025