Urinary Incontinence Clinical Trial
— LO-BOTOfficial 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)
Verified date | December 2019 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 symptoms have not been adequately managed with an anticholinergic.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 10, 2018 |
Est. primary completion date | December 10, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Urologic Consultants of Southeastern Pennsylvania | Bala-Cynwyd | Pennsylvania |
United States | PMG Research of Christie Clinic | Champaign | Illinois |
United States | Western New York Urology Associates | Cheektowaga | New York |
United States | Urology Clinics of North Texas | Dallas | Texas |
United States | Genitourinary Surgical Consultants | Denver | Colorado |
United States | Premier Urology LLC | Edison | New Jersey |
United States | Deaconess Clinic, Inc. | Evansville | Indiana |
United States | Women's Health Advantage | Fort Wayne | Indiana |
United States | Center for Pelvic Health | Franklin | Tennessee |
United States | Alliance Urology Specialists | Greensboro | North Carolina |
United States | Sandhills Medical Center | Hamlet | North Carolina |
United States | Urogynecology Associates | Indianapolis | Indiana |
United States | East Coast Institute for Research, LLC | Jacksonville | Florida |
United States | Beyer Research | Kalamazoo | Michigan |
United States | Orange County Urology Associates | Laguna Hills | California |
United States | Tower Urology | Los Angeles | California |
United States | Integrity Medical Research, LLC | Mountlake Terrace | Washington |
United States | Manhattan Medical Research | New York | New York |
United States | Urology of Indiana | Noblesville | Indiana |
United States | Adult and Pediatric Urology | Omaha | Nebraska |
United States | University of California, Irvine Medical Center | Orange | California |
United States | Chesapeake Urology | Owings Mills | Maryland |
United States | Advanced Urology Centers of NY A division of IMP | Plainview | New York |
United States | Premier Medical Group of the Hudson Valley | Poughkeepsie | New York |
United States | Virginia Urology | Richmond | Virginia |
United States | Virginia Urology Center | Richmond | Virginia |
United States | Regional Urology | Shreveport | Louisiana |
United States | Michigan Institute of Urology, P.C. | Troy | Michigan |
United States | Urology of Virginia | Virginia Beach | Virginia |
United States | Iowa Clinic | West Des Moines | Iowa |
United States | PMG Research of Wilmington | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12 | |
Secondary | Percentage of Participants Who Achieved Complete Continence | Complete continence is defined as 100% reduction in urinary incontinence from Baseline. | Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12] | |
Secondary | 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. | Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12 | |
Secondary | 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. | Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12 | |
Secondary | 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. | Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to, 3 consecutive days prior to Week 12 | |
Secondary | 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. | Week 12 |
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