Urinary Bladder, OveractivePhase 4LO-BOTNCT03052764

Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence

A Phase 4 study testing onabotulinumtoxinA in people with Urinary Bladder, Overactive and Urinary Incontinence, run by Allergan at 31 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the efficacy and safety of onabotulinumtoxinA 100 U (BOTOX®), compared to placebo, when injected into the bladder using an alternative injection paradigm in reducing the number of daily urinary incontinence episodes in patients with overactive bladder (OAB) and urinary incontinence whose… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Urinary Bladder, Overactive, Urinary Incontinence
What is being tested?: onabotulinumtoxinA
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 31 sitesUnited States
Study dates: 12 Dec 2016to 10 Dec 2018
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant weighs ≥ 40 kg (88 lb)
Participant has symptoms of Over Active Bladder (OAB) (frequency and urgency) with urinary incontinence for a period of at least 6 months immediately prior to screening.

Who cannot join

Participant has symptoms of OAB due to any known neurological reason (eg, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.)
Participant has received pharmacologic therapy to treat symptoms of OAB, including nocturia, within 7 days of the start of the screening period procedures
Participant uses clean intermittent catheterization (CIC) or indwelling catheter to manage urinary incontinence
Participant has been treated with any intravesical pharmacologic agent (eg, capsaicin, resiniferatoxin) within 12 months of Day 1
Participant has had previous or current botulinum toxin therapy of any serotype for any urological condition
Participant has had previous or current botulinum toxin therapy of any serotype for any non-urological condition within 12 weeks of Day 1

Show all 18Show fewer

Participant has been immunized for any botulinum toxin serotype
Participant has history or evidence of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
Participant has an active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening
Participant has a history or current diagnosis of bladder cancer or other urothelial malignancy
Participant is male with previous or current diagnosis of prostate cancer
Participant has a history of 2 or more urinary tract infections (UTIs) within 6 months of Day 1 or is taking prophylactic antibiotics to prevent chronic UTIs
Participant has current or previous uninvestigated hematuria
Participant has hemophilia, or other clotting factor deficiencies, or disorders that cause bleeding diathesis
Participant cannot withhold any antiplatelet, anticoagulant therapy or medications with anticoagulant effects for 3 days prior to Day 1
Participant has a known allergy or sensitivity to any botulinum toxin preparation
Participant has any medical condition that may put him/her at increased risk with exposure to BOTOX® including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Participant has current swallowing or breathing difficulties.

Trial locations and contacts

31 sites in 1 country.

City, postcode or hospital

31 sites in 1 country

United States31 sites

Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004
PMG Research of Christie Clinic
Champaign, Illinois, 81820
Western New York Urology Associates
Cheektowaga, New York, 14225
Urology Clinics of North Texas
Dallas, Texas, 75231
Genitourinary Surgical Consultants
Denver, Colorado, 80220
Premier Urology LLC
Edison, New Jersey, 08837
Deaconess Clinic, Inc.
Evansville, Indiana, 47113
Women's Health Advantage
Fort Wayne, Indiana, 46825
Center for Pelvic Health
Franklin, Tennessee, 37067
Alliance Urology Specialists
Greensboro, North Carolina, 27403
Sandhills Medical Center
Hamlet, North Carolina, 28345
Urogynecology Associates
Indianapolis, Indiana, 46062
East Coast Institute for Research, LLC
Jacksonville, Florida, 32204
Beyer Research
Kalamazoo, Michigan, 49009
Orange County Urology Associates
Laguna Hills, California, 92653
Tower Urology
Los Angeles, California, 90048
Integrity Medical Research, LLC
Mountlake Terrace, Washington, 98043
Manhattan Medical Research
New York, New York, 10016
Urology of Indiana
Noblesville, Indiana, 46062
Adult and Pediatric Urology
Omaha, Nebraska, 68114
University of California, Irvine Medical Center
Orange, California, 92868
Chesapeake Urology
Owings Mills, Maryland, 21117
Advanced Urology Centers of NY A division of IMP
Plainview, New York, 11803
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601
Virginia Urology
Richmond, Virginia, 23230
Virginia Urology Center
Richmond, Virginia, 23235
Regional Urology
Shreveport, Louisiana, 71106
Michigan Institute of Urology, P.C.
Troy, Michigan, 48084
Urology of Virginia
Virginia Beach, Virginia, 23462
Iowa Clinic
West Des Moines, Iowa, 50266
PMG Research of Wilmington
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence (LO-BOT)

Conditions: Urinary Bladder, Overactive, Urinary Incontinence
Being tested: onabotulinumtoxinA, Placebo (saline)
Medical subject headings: Urinary Bladder, Overactive, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

onabotulinumtoxinABiological
Also called BOTOX®, botulinum toxin Type A
OnabotulinumtoxinA (BOTOX®) injection into the bladder.
Placebo (saline)Drug
Placebo (saline) injection into the bladder.

Study groups in NCT03052764
Study group	Role	What they receive
BOTOX® 100 U/BOTOX® 100 U	Active comparator	BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable. Receives: Biological: onabotulinumtoxinA
Placebo/BOTOX® 100 U	Placebo comparator	Placebo (saline) injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable. Receives: Biological: onabotulinumtoxinA; Drug: Placebo (saline)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Daily Average Number of Urinary Incontinence Episodes
The participant recorded urinary incontinence in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An analysis of covariance (ANCOVA) model with treatment as a factor at 2 levels, and the number of Urgency Urinary Incontinence (UUI) episodes reported at Baseline (<= 9 versus > 9 daily episodes) and Baseline daily average number of episodes of incontinence as covariates was used for analyses.
Measured: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12

Secondary outcomes (5)

Percentage of Participants Who Achieved Complete Continence
Complete continence is defined as 100% reduction in urinary incontinence from Baseline.
Measured: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12]
Change From Baseline in Daily Average Number of Micturition Episodes
The participant recorded the number of micturition episodes in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (<= 9 versus > 9 daily episodes) and Baseline daily average number of micturition as covariates was used for analyses.
Measured: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12
Change From Baseline in Daily Average Number of Urgency Episodes
The participant recorded the number of urgency episode in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (<= 9 versus > 9 daily episodes) and Baseline daily average number of urgency episodes as covariates was used for analyses.
Measured: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12
Change From Baseline in Daily Average Number of Nocturia Episodes
The participants recorded the number of nocturia episodes in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (<= 9 versus > 9 daily episodes) and Baseline daily average number of nocturia episodes as covariates was used for analyses.
Measured: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to, 3 consecutive days prior to Week 12
Percentage of Participants Who Have a Positive Treatment Response on the Treatment Benefit Scale (TBS)
The participant rated their condition during treatment using the TBS 4-point scale where: 1=greatly improved, 2=improved, 3=not changed or 4=worsened. A positive treatment response is either as score of 1=greatly improved or 2=improved.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 201610 Dec 2018

First posted14 Feb 2017
Study start12 Dec 2016
Primary completion10 Dec 2018
Study completion10 Dec 2018

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 Urinary Bladder, OveractiveStudies of the same condition, open and under way.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03052764
Sponsor's protocol ID: CMO-US-URO-0470
Acronym: LO-BOT
Status last verified: Dec 2019
First submitted: 10 Feb 2017
Last updated: 24 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Poster. Female Pelvic Med Reconstr Surg. 2020 Oct 1;26(10S Suppl 1):S89-S189. doi: 10.1097/SPV.0000000000000936. No abstract available.
PubMed 33955921

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Overactive Bladder (OAB)

All Urinary Bladder, Overactive trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence (LO-BOT)
ClinicalTrials.gov ID: NCT03052764
Acronym / sponsor ID: LO-BOT / CMO-US-URO-0470
Conditions: Urinary Bladder, Overactive, Urinary Incontinence
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 12 Dec 2016 (actual)
Primary completion: 10 Dec 2018 (actual)
Study completion: 10 Dec 2018 (actual)
First posted: 14 Feb 2017 (actual)
Results: Posted 24 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
BOTOX® 100 U/BOTOX® 100 U	Active comparator	Biological: onabotulinumtoxinABOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable.
Placebo/BOTOX® 100 U	Placebo comparator	Biological: onabotulinumtoxinA, Drug: Placebo (saline)Placebo (saline) injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Participant weighs ≥ 40 kg (88 lb)
Participant has symptoms of Over Active Bladder (OAB) (frequency and urgency) with urinary incontinence for a period of at least 6 months immediately prior to screening.

Key exclusion criteria (18 listed)

Participant has symptoms of OAB due to any known neurological reason (eg, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.)
Participant has received pharmacologic therapy to treat symptoms of OAB, including nocturia, within 7 days of the start of the screening period procedures
Participant uses clean intermittent catheterization (CIC) or indwelling catheter to manage urinary incontinence
Participant has been treated with any intravesical pharmacologic agent (eg, capsaicin, resiniferatoxin) within 12 months of Day 1
Participant has had previous or current botulinum toxin therapy of any serotype for any urological condition

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
onabotulinumtoxinAAlso: BOTOX®, botulinum toxin Type AOnabotulinumtoxinA (BOTOX®) injection into the bladder.	Biological	BOTOX® 100 U/BOTOX® 100 U, Placebo/BOTOX® 100 U
Placebo (saline)Placebo (saline) injection into the bladder.	Drug	Placebo/BOTOX® 100 U

Primary outcome

Change From Baseline in Daily Average Number of Urinary Incontinence Episodes
Time frame: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12
The participant recorded urinary incontinence in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An analysis of covariance (ANCOVA) model with treatment as a factor at 2 levels, and the number of Urgency Urinary Incontinence (UUI) episodes reported at Baseline (<= 9 versus > 9 daily episodes) and Baseline daily average number of episodes of incontinence as covariates was used for analyses.

5 secondary outcomes

Percentage of Participants Who Achieved Complete Continence
Time frame: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12]
Change From Baseline in Daily Average Number of Micturition Episodes
Time frame: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12
Change From Baseline in Daily Average Number of Urgency Episodes
Time frame: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12
Change From Baseline in Daily Average Number of Nocturia Episodes
Time frame: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to, 3 consecutive days prior to Week 12
Percentage of Participants Who Have a Positive Treatment Response on the Treatment Benefit Scale (TBS)
Time frame: Week 12

Results and safety

Results posted to the registry on 24 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BOTOX® 100 U/BOTOX® 100 U	80	70
Placebo/BOTOX® 100 U	40	37

Primary outcome: Change From Baseline in Daily Average Number of Urinary Incontinence Episodes

Time frame: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12. Least squares mean (Standard Error). Unit: incontinence episodes per day

Measure	BOTOX® 100 U/BOTOX® 100 U n = 78	Placebo/BOTOX® 100 U n = 39
Value	-2.99 (0.488)	-0.42 (0.612)

BOTOX® 100 U/BOTOX® 100 U vs Placebo/BOTOX® 100 U: Least Squares Mean Difference: -2.57 (95% CI -3.68 to -1.46), p <.0001, ANCOVA

Population analysed: Modified Intent-to-treat (mITT) Population included all randomized participants who had at least one efficacy assessment at Baseline and a postbaseline visit.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Randomization to the Study Exit Visit (Up to 70 Weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Double Blind: BOTOX® 100 U	5 of 78 (6.4%)	31 of 78 (39.7%)	0 of 80
Double Blind: Placebo	2 of 39 (5.1%)	13 of 39 (33.3%)	0 of 40
Open Label: BOTOX® 100 U/BOTOX® 100 U	2 of 58 (3.4%)	14 of 58 (24.1%)	0 of 58
Open Label: Placebo/BOTOX® 100 U	1 of 33 (3%)	16 of 33 (48.5%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33955921Poster. Female Pelvic Med Reconstr Surg. 2020 Oct 1;26(10S Suppl 1):S89-S189. doi: 10.1097/SPV.0000000000000936. No abstract available.

Related trials for Urinary Bladder, Overactive

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Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
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Overactive Bladder (OAB)

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.

Dana Fetterolf study director

Allergan

Amin Boroujerdi study director

Allergan

31 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 in people with Urinary Bladder, Overactive and Urinary Incontinence, run by Allergan at 31 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 2 inclusion and 18 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 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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. Some participants in this study may receive a placebo. 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 24 Dec 2019). 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?

Change From Baseline in Daily Average Number of Urinary Incontinence Episodes (time frame: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12). 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 NCT03052764, 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 24 Dec 2019.