20 Botox Injections for Overactive Bladder

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Urology clinic locations at Wake Forest Baptist Medical Center, Winston-Salem, NCOveractive BladderOnabotulinumtoxinA 100 UNT - Drug
Eligibility
18 - 90
Female
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 12 weeks post procedure

12 weeks post procedure
Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life
Over Active Bladder (OAB) Questionnaire Short Form - Symptoms
Participant's Global Impression of Change (PGIC) Scale
Post-Void Residual (PVR)
Week 12
Difference in mean urge incontinence episodes
Post Procedure Day 1
Pain

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

20 Botox Injections
1 of 2
10 Botox Injections
1 of 2

Active Control

40 Total Participants · 2 Treatment Groups

Primary Treatment: 20 Botox Injections · No Placebo Group · Phase 4

20 Botox Injections
Drug
ActiveComparator Group · 1 Intervention: OnabotulinumtoxinA 100 UNT · Intervention Types: Drug
10 Botox Injections
Drug
ActiveComparator Group · 1 Intervention: OnabotulinumtoxinA 100 UNT · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks post procedure

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,149 Previous Clinical Trials
1,140,966 Total Patients Enrolled
Catherine Matthews, MDPrincipal InvestigatorWake Forest University Health Sciences
6 Previous Clinical Trials
632 Total Patients Enrolled

Eligibility Criteria

Age 18 - 90 · Female Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a woman.
You have already planned to receive Botox injections in your bladder to treat overactive bladder.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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)." - Anonymous Online Contributor

Unverified Answer

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

"Individuals aged 18 to 90 years old are being considered for this trial." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.