NCT04124939

Is 10 Injections of Bladder Botox Less Painful Than 20 Injections?

Completed Phase 4 Results posted Last updated 17 April 2024

What this trial tests

Phase 4 trial testing OnabotulinumtoxinA 100 Units in Overactive Bladder in 41 participants. Completed in 23 February 2023.

Timeline

10 November 2019

Primary endpoint
9 November 2022

23 February 2023

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	41
Start date	10 November 2019
Primary completion	9 November 2022
Estimated completion	23 February 2023
Sites	2 locations across United States

Drugs / interventions tested

• OnabotulinumtoxinA 100 Units — full drug profile →

Conditions studied

• Overactive Bladder — all drugs for Overactive Bladder →

Sponsor

Wake Forest University Health Sciences

Who can join

Adults 18 to 90, female only, with Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Numeric Pain Rating Scale (NPRS) Primary · Post Procedure Day 1

The patients will rate their level of pain from 0 as no pain to 10 as a severe pain immediately following the completion of bladder injections by selecting a whole number from 0 to 10 that represents their level of pain during the procedure.

Group	Value	95% CI
10 Botox Injections	4	1.5 – 5
20 Botox Injections	3	1 – 4

Difference in Mean Urge Incontinence Episodes Secondary · Week 12 after procedure

The mean urge incontinence episodes which will be calculated by averaging the amount of urge urinary incontinence episodes over 3 days as recorded in a bladder diary at week 12 after the procedure

Group	Value	95% CI
10 Botox Injections	1.64	1 – 1.82
20 Botox Injections	1.35	0 – 2

Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms Secondary · Baseline

Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life

Group	Value	95% CI
10 Botox Injections	29.67	± 5.43
20 Botox Injections	25.89	± 7.45

Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms Secondary · 2 weeks post procedure

Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life

Group	Value	95% CI
10 Botox Injections	17.1	± 7.21
20 Botox Injections	17.0	± 17.83

Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms Secondary · 12 weeks post procedure

Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life

Group	Value	95% CI
10 Botox Injections	15.53	± 6.18
20 Botox Injections	16.41	± 6.48

Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life Secondary · Baseline

Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.

Group	Value	95% CI
10 Botox Injections	56.04	± 13.46
20 Botox Injections	47.94	± 20.36

Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life Secondary · 2 weeks post procedure

Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.

Group	Value	95% CI
10 Botox Injections	28.71	± 14.26
20 Botox Injections	23.63	± 14.04

Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life Secondary · 12 weeks post procedure

Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.

Group	Value	95% CI
10 Botox Injections	27.74	± 12.92
20 Botox Injections	27.00	± 11.20

Post-Void Residual (PVR) Secondary · 2 weeks post procedure

PVR using bladder scanner evaluates the post void residual in the bladder.

Group	Value	95% CI
10 Botox Injections	93.87	± 79.37
20 Botox Injections	71.93	± 89.62

Post-Void Residual (PVR) Secondary · 12 weeks post procedure

PVR using bladder scanner evaluates the post void residual in the bladder.

Group	Value	95% CI
10 Botox Injections	17.5	0 – 91
20 Botox Injections	61	0 – 125

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

10 Botox Injections

Serious: 0/21 (0%)

Deaths: 0/21

20 Botox Injections

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (1 terms — click to expand)

Reaction	System	10 Botox Injections	20 Botox Injections
Urinary Tract Infection	Renal and urinary disorders	—	—

Data from ClinicalTrials.gov NCT04124939 adverse events section.

Sponsor's own description

The purpose of this research study is to help determine if 10 injections of Botox ® 100 units is less painful than 20 injections of Botox ® 100 units based on effectiveness in reducing urge incontinence episodes. Study will also be assessed for the pain of procedure and adverse outcomes of 20 injections versus 10 injections.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.