Overactive BladderPhase 4NCT04124939
Is 10 Injections of Bladder Botox Less Painful Than 20 Injections?
A Phase 4 study testing OnabotulinumtoxinA 100 Units in people with Overactive Bladder, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- OnabotulinumtoxinA 100 Units
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Nov 2019to 23 Feb 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female gender
- At least 18 years of age
- Have already decided to undergo intradetrusor Botox® injections for treatment of refractory overactive bladder.
- Able and willing to learn clean intermittent catheterization (or care provider is willing and able to perform intermittent catheterization).
- Understands and is willing to undergo follow up and complete questionnaires as described in this protocol
- Able to give informed consent
Who cannot join
- Male gender
- Neurological conditions (Examples: Cerebral vascular accident within 6 months prior to treatment, Parkinson's disease, Multiple Sclerosis, and Spina Bifida).
- Acute urinary tract infection
- Treatment with Botox® toxin for other conditions
- Allergy to Botox® toxin
- Hematuria that has not been worked up
Show all 12Show fewer
- Known bladder malignancy
- Previous history of bladder augmentation
- Currently pregnant (with no plans to become pregnant within 6 months of enrollment) or breastfeeding
- Currently taking aminoglycoside antibiotics
- Post-void residual (PVR) >150 cc (measured by bladder scan or by catheterization) prior to enrollment
- History of chronic pain or pain syndromes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Urology clinic locations at Wake Forest Baptist Medical Center
Greensboro, North Carolina, 27455
Urology clinic locations at Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized Clinical Trial of 100 Units of Intradetrusor Onabotulinum Toxin A for Refractory Overactive Bladder - Is 10 Injections Less Painful Than 20 Injections?
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.
Read the detailed description
This study is a randomized clinical trial to assess whether or not 10 injections of 100 units of intradetrusor Botox® toxin is perceived as less painful compared to 20 injections of 100 units of intradetrusor Botox® toxin for the treatment of refractory overactive bladder.
- Conditions
- Overactive Bladder
- Being tested
- OnabotulinumtoxinA 100 Units
- Keywords
- Overactive Bladder, Botox/OnabotulinumtoxinA, Pain, OAB, Non-neurogenic Overactive bladder
- Medical subject headings
- Urinary Bladder, Overactive, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinA 100 UnitsDrug
Also called BOTOX
BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:
- Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
| Study group | Role | What they receive |
|---|---|---|
| 10 Botox Injections | Active comparator | 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. Receives: Drug: OnabotulinumtoxinA 100 Units |
| 20 Botox Injections | Active comparator | 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. Receives: Drug: OnabotulinumtoxinA 100 Units |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
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.
Measured: Post Procedure Day 1
Secondary outcomes (9)
Difference in Mean Urge Incontinence Episodes
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
Measured: Week 12 after procedure
Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms
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
Measured: Baseline
Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms
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
Measured: 2 weeks post procedure
Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms
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
Measured: 12 weeks post procedure
Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life
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.
Measured: Baseline
Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life
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.
Measured: 2 weeks post procedure
Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life
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.
Measured: 12 weeks post procedure
Post-Void Residual (PVR)
PVR using bladder scanner evaluates the post void residual in the bladder.
Measured: 2 weeks post procedure
Post-Void Residual (PVR)
PVR using bladder scanner evaluates the post void residual in the bladder.
Measured: 12 weeks post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start10 Nov 2019
- Primary completion9 Nov 2022
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Matthews, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124939
- Sponsor's protocol ID
- IRB00059454
- Status last verified
- Aug 2022
- First submitted
- 10 Oct 2019
- Last updated
- 17 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zdroik A, El Haraki A, Smith W, Badlani G, Parker-Autry C, Matthews C. Injection site number and outcomes of intradetrusor onabotulinumtoxinA for refractory overactive bladder syndrome: a randomized clinical trial. Int Urogynecol J. 2024 Jan;35(1):119-126. doi: 10.1007/s00192-023-05685-0. Epub 2023 Nov 22.
PubMed 37991564
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of 100 Units of Intradetrusor Onabotulinum Toxin A for Refractory Overactive Bladder - Is 10 Injections Less Painful Than 20 Injections?
- ClinicalTrials.gov ID
- NCT04124939
- Acronym / sponsor ID
- IRB00059454
- Conditions
- Overactive Bladder
- Keywords
- Overactive Bladder, Botox/OnabotulinumtoxinA, Pain, OAB, Non-neurogenic Overactive bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 10 Nov 2019 (actual)
- Primary completion
- 9 Nov 2022 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 14 Oct 2019 (actual)
- Results
- Posted 13 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomized clinical trial to assess whether or not 10 injections of 100 units of intradetrusor Botox® toxin is perceived as less painful compared to 20 injections of 100 units of intradetrusor Botox® toxin for the treatment of refractory overactive bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 Botox Injections | Active comparator | Drug: OnabotulinumtoxinA 100 Units100 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. |
| 20 Botox Injections | Active comparator | Drug: OnabotulinumtoxinA 100 Units100 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female gender
- At least 18 years of age
- Have already decided to undergo intradetrusor Botox® injections for treatment of refractory overactive bladder.
- Able and willing to learn clean intermittent catheterization (or care provider is willing and able to perform intermittent catheterization).
- Understands and is willing to undergo follow up and complete questionnaires as described in this protocol
Key exclusion criteria (12 listed)
- Male gender
- Neurological conditions (Examples: Cerebral vascular accident within 6 months prior to treatment, Parkinson's disease, Multiple Sclerosis, and Spina Bifida).
- Acute urinary tract infection
- Treatment with Botox® toxin for other conditions
- Allergy to Botox® toxin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnabotulinumtoxinA 100 UnitsAlso: BOTOXBOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: • Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication. | Drug | 10 Botox Injections, 20 Botox Injections |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 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.
9 secondary outcomes
Difference in Mean Urge Incontinence Episodes
Time frame: Week 12 after procedure
Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms
Time frame: Baseline
Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms
Time frame: 2 weeks post procedure
Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms
Time frame: 12 weeks post procedure
Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life
Time frame: Baseline
Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life
Time frame: 2 weeks post procedure
Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life
Time frame: 12 weeks post procedure
Post-Void Residual (PVR)
Time frame: 2 weeks post procedure
Post-Void Residual (PVR)
Time frame: 12 weeks post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37991564Zdroik A, El Haraki A, Smith W, Badlani G, Parker-Autry C, Matthews C. Injection site number and outcomes of intradetrusor onabotulinumtoxinA for refractory overactive bladder syndrome: a randomized clinical trial. Int Urogynecol J. 2024 Jan;35(1):119-126. doi: 10.1007/s00192-023-05685-0. Epub 2023 Nov 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Matthews, MD principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OnabotulinumtoxinA 100 Units in people with Overactive Bladder, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: Post Procedure Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04124939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.