Urinary IncontinencePhase 3NCT02097121
OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)
A Phase 3 study testing BOTOX® in people with Urinary Incontinence and Urinary Bladder, run by Allergan at 39 sites in 13 countries.
Trial summary
This was a multicenter, randomized, double-blind, parallel-group, multiple-dose study to evaluate the efficacy and safety of BOTOX in adolescents with urinary incontinence due to overactive bladder (OAB) with inadequate management with anticholinergic therapy. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Urinary Incontinence, Urinary Bladder, Overactive
- What is being tested?
- BOTOX®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 39 sitesin 13 countries
- Study dates
- 23 May 2014to 10 Feb 2022
- Phase
- Phase 3
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Symptoms of overactive bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months
- OAB symptoms not adequately managed by 1 or more anticholinergic agents
Who cannot join
- OAB caused by a neurological condition
- Use of anticholinergics or other medications to treat OAB symptoms within 7 days
- Current use of indwelling catheter or clean intermittent catheterization to empty the bladder
- Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype within 3 months for any other condition or use
- Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Trial locations and contacts
39 sites in 13 countries.
39 sites in 13 countries
United States8 sites
Alaska Urological Institute /ID# 238189
Anchorage, Alaska, 99503-3902
Children's Hospital Colorado /ID# 237621
Aurora, Colorado, 80045
Cook Children's Med. Center /ID# 237539
Fort Worth, Texas, 76104
Arkansas Children's Hospital /ID# 237787
Little Rock, Arkansas, 72202
Children's Hospital Wisconsin - Milwaukee Campus /ID# 237544
Milwaukee, Wisconsin, 53226
Yale New Haven Hospital - Yale School of Medicine /ID# 238222
New Haven, Connecticut, 06510-3206
Orlando Health-Arnold Palmer Hospital for Children Pediatric Urology /ID# 235283
Orlando, Florida, 32806
Associated Urologist of North Carolina /ID# 235437
Raleigh, North Carolina, 27612
United Kingdom7 sites
NHS Grampian /ID# 237379
Aberdeen, AB15 6RE
NHS Greater Glasgow and Clyde /ID# 237430
Glasgow, Scotland, G12 0XH
Alder Hey Children's NHS Foundation Trust /ID# 237279
Liverpool, L12 2AP
Manchester University NHS Foundation Trust /ID# 234380
Manchester, Lancashire, M13 9WL
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 234819
Norwich, Norfolk, NR4 7UY
Royal Berkshire NHS Foundation Trust /ID# 236915
Reading, RG1 5AN
Sheffield Children's NHS Foundation Trust /ID# 237854
Sheffield, S10 2TH
Australia3 sites
Monash Children's Hospital /ID# 234388
Clayton, Victoria, 3168
Sydney Children's Hospital /ID# 237191
Randwick, New South Wales, 2031
The Children's Hospital at Westmead /ID# 234337
Sydney, New South Wales, 2145
Belgium3 sites
Universitair Ziekenhuis Antwerpen /ID# 237997
Edegem, Antwerpen, 2650
UZ Gent /ID# 237588
Ghent, Oost-Vlaanderen, 9000
Universitair Ziekenhuis Leuven /ID# 237218
Leuven, Vlaams-Brabant, 3000
Canada3 sites
Alberta Children's Hospital /ID# 237510
Calgary, Alberta, T3B 6A8
London Health Sciences Center /ID# 234304
London, Ontario, N6A 5W9
CHUS - Hopital Fleurimont /ID# 237668
Sherbrooke, Quebec, J1H 5N4
France3 sites
Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 237392
Bordeaux, 33076
Hôpital de la Mère et de l'Enfant /ID# 235227
Limoges, 87042
Hôpitaux Pédiatriques de Nice CHU-LENVAL /ID# 235278
Nice, 06200
Germany3 sites
Evangelisches Krankenhaus Bielefeld /ID# 235234
Bielefeld, 33617
Urologische Gemeinschaftspraxis /ID# 234978
Emmendingen, 79312
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 234288
Lübeck, 23538
Poland3 sites
Specjalistyczny Gabinet Lekarski /ID# 235257
Poznan, 61-512
Medical Concierge Centrum Medyczne /ID# 235200
Warsaw, 02-798
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 238166
Wroclaw, Lower Silesian Voivodeship, 50-556
Netherlands2 sites
Maastricht Universitair Medisch Centrum /ID# 237678
Maastricht, 6229 HX
Radboud Universitair Medisch Centrum /ID# 237043
Nijmegen, Gelderland, 6525 GA
Italy1 site
AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 237308
Naples, 80138
About this study
Official title: BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age
This was a multicenter, randomized, double-blind, parallel-group, multiple-dose study to evaluate the efficacy and safety of BOTOX in adolescents with urinary incontinence due to overactive bladder (OAB) with inadequate management with anticholinergic therapy. Participants were randomized in a 1:1:1 ratio to receive a single Tx of 25 U, 50 U, or 100 U BOTOX (not to exceed 6 U/kg) on Day 1, were seen after each treatment at Weeks 2, 6, and 12 post-treatment, and thereafter at alternating telephone and clinic visits every 6 weeks until they qualified for further retreatment/exited the study. Participants could receive multiple treatments dependent upon the number and timing of patient requests/qualification for retreatment. At each retreatment the investigator could keep the dose the same or increase it one dose level in a blinded fashion. Participants exited the study once 96 weeks have elapsed since entry on Day 1 and at least 12 weeks follow-up since their last study treatment had occurred.
- Conditions
- Urinary Incontinence, Urinary Bladder, Overactive
- Being tested
- BOTOX®
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOTOX®Biological
Also called Botulinum Toxin Type A
Each vial of BOTOX (Botulinum Toxin Type A) purified neurotoxin complex, formulation No. 9060X contains 100 U of Clostridium botulinum toxin Type A, 0.5 mg albumin (human), and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. The study medication was to be reconstituted with 0.9% sodium chloride (preservative-free). The 10 mL of study drug was to be administered as 20 injections each of 0.5 mL. Under direct cystoscopic visualization, injections were to be distributed evenly across the detrusor wall and spaced approximately 1 cm apart. To avoid injecting the trigone, the injections were to be at least 1 cm above the trigone. The injection needle was to be inserted approximately 2 mm into the detrusor for each injection.
| Study group | Role | What they receive |
|---|---|---|
| Botox 25 U | Experimental | Participants randomized to receive 25 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment. Receives: Biological: BOTOX® |
| Botox 50 U | Experimental | Participants randomized to receive 50 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment. Receives: Biological: BOTOX® |
| Botox 100 U | Experimental | Participants randomized to receive 100 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment. Receives: Biological: BOTOX® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Measured: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Secondary outcomes (11)
Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Micturition Episodes
Micturition was defined as toilet voids recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime micturition episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Measured: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Urgency Episodes
Participants recorded daytime urgency episodes in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime urgency episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Measured: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Percentage of Participants With Night Time Urinary Incontinence
Urinary incontinence was defined as involuntary loss of urine. Participants recorded night time urinary incontinence episodes in a bladder diary during 2 consecutive days in the week prior to the study visit. Night time is defined as the time between going to bed to sleep for the night and waking up to start the next day. The number of daily night time urinary incontinence episodes were averaged during the 2-day period. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Measured: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Change From Study Baseline in the Daily Average Volume Voided Per Micturition (mL)
The volume per micturition was derived from the total urine volume voided over 1 daytime period during the 2-day bladder diary collection period divided by the number of voids in the same daytime period. Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Measured: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Change From Study Baseline in Pediatric Urinary Incontinence Quality of Life Total Score (PinQ)
The PinQ is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time) and a total sum score is calculated (from 0 to 80), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Measured: From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Change From Study Baseline in PinQ Item 'I am Worried That People Might Think my Clothes Smell Like Pee"
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Measured: From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Change From Study Baseline in PinQ Item 'My Bladder Problem Makes me Feel Bad About Myself"
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Measured: From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Change From Study Baseline in PinQ Item 'I Miss Out on Being With Friends Because of my Bladder Problems"
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Measured: From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Percentage of Participants With a Positive Treatment Response in the Modified Treatment Benefit Scale
The Modified Treatment Benefit Scale (Modified TBS) is a single-item scale designed to assess the change in the participant's overactive bladder (OAB) condition following treatment. The participant's current condition (urinary problems, urinary incontinence) is compared to their condition prior to receipt of any study treatment by selection of "greatly improved", "improved", "not changed" or "worsened". Participants who selected "greatly improved" or "improved" were considered to have a positive treatment response.
Measured: At Week 12 in Treatment Cycle 1
Time to Participant's First Request for Retreatment
The time from the day of BOTOX treatment to the request for the subsequent treatment was estimated using a Kaplan-Meier survival method for each treatment group. Participants who did not request retreatment were treated as censored at the time of their last study visit or study exit.
Measured: From the day of BOTOX treatment in Treatment Cycle 1 to the request for subsequent treatment
Time to Participant's Qualification for Retreatment
The time from the day of BOTOX treatment to the qualification for retreatment was estimated using a Kaplan-Meier survival method for each treatment group. Participants who did not qualify for retreatment were treated as censored at the time of their last study visit or study exit.
Measured: From the day of BOTOX treatment in Treatment Cycle 1 to the qualification for retreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study start23 May 2014
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
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.
- Other trials for Urinary IncontinenceStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ALLERGAN INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097121
- Sponsor's protocol ID
- 191622-137
- Other IDs
- 2014-000464-17, 2014
- Status last verified
- Nov 2022
- First submitted
- 24 Mar 2014
- Last updated
- 28 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age
- ClinicalTrials.gov ID
- NCT02097121
- Acronym / sponsor ID
- 191622-137
- Conditions
- Urinary Incontinence, Urinary Bladder, Overactive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 56 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 23 May 2014 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Posted 28 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a multicenter, randomized, double-blind, parallel-group, multiple-dose study to evaluate the efficacy and safety of BOTOX in adolescents with urinary incontinence due to overactive bladder (OAB) with inadequate management with anticholinergic therapy. Participants were randomized in a 1:1:1 ratio to receive a single Tx of 25 U, 50 U, or 100 U BOTOX (not to exceed 6 U/kg) on Day 1, were seen after each treatment at Weeks 2, 6, and 12 post-treatment, and thereafter at alternating telephone and clinic visits every 6 weeks until they qualified for further retreatment/exited the study. Participants could receive multiple treatments dependent upon the number and timing of patient requests/qualification for retreatment. At each retreatment the investigator could keep the dose the same or increase it one dose level in a blinded fashion. Participants exited the study once 96 weeks have elapsed since entry on Day 1 and at least 12 weeks follow-up since their last study treatment had occurred.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Botox 25 U | Experimental | Biological: BOTOX®Participants randomized to receive 25 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment. |
| Botox 50 U | Experimental | Biological: BOTOX®Participants randomized to receive 50 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment. |
| Botox 100 U | Experimental | Biological: BOTOX®Participants randomized to receive 100 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Symptoms of overactive bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months
- OAB symptoms not adequately managed by 1 or more anticholinergic agents
Key exclusion criteria (5 listed)
- OAB caused by a neurological condition
- Use of anticholinergics or other medications to treat OAB symptoms within 7 days
- Current use of indwelling catheter or clean intermittent catheterization to empty the bladder
- Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype within 3 months for any other condition or use
- Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
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 |
|---|---|---|
| BOTOX®Also: Botulinum Toxin Type AEach vial of BOTOX (Botulinum Toxin Type A) purified neurotoxin complex, formulation No. 9060X contains 100 U of Clostridium botulinum toxin Type A, 0.5 mg albumin (human), and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. The study medication was to be reconstituted with 0.9% sodium chloride (preservative-free). The 10 mL of study drug was to be administered as 20 injections each of 0.5 mL. Under direct cystoscopic visualization, injections were to be distributed evenly across the detrusor wall and spaced approximately 1 cm apart. To avoid injecting the trigone, the injections were to be at least 1 cm above the trigone. The injection needle was to be inserted approximately 2 mm into the detrusor for each injection. | Biological | Botox 100 U, Botox 25 U, Botox 50 U |
Primary outcome
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1
Time frame: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
11 secondary outcomes
Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Micturition Episodes
Time frame: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Urgency Episodes
Time frame: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Percentage of Participants With Night Time Urinary Incontinence
Time frame: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Change From Study Baseline in the Daily Average Volume Voided Per Micturition (mL)
Time frame: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Change From Study Baseline in Pediatric Urinary Incontinence Quality of Life Total Score (PinQ)
Time frame: From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Change From Study Baseline in PinQ Item 'I am Worried That People Might Think my Clothes Smell Like Pee"
Time frame: From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Change From Study Baseline in PinQ Item 'My Bladder Problem Makes me Feel Bad About Myself"
Time frame: From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Change From Study Baseline in PinQ Item 'I Miss Out on Being With Friends Because of my Bladder Problems"
Time frame: From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Percentage of Participants With a Positive Treatment Response in the Modified Treatment Benefit Scale
Time frame: At Week 12 in Treatment Cycle 1
Time to Participant's First Request for Retreatment
Time frame: From the day of BOTOX treatment in Treatment Cycle 1 to the request for subsequent treatment
Time to Participant's Qualification for Retreatment
Time frame: From the day of BOTOX treatment in Treatment Cycle 1 to the qualification for retreatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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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.
ALLERGAN INC. study director
Allergan
39 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BOTOX® in people with Urinary Incontinence and Urinary Bladder, run by Allergan at 39 sites in 13 countries.
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 5 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: stopped early, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, United Kingdom, Australia, Belgium, Canada and 8 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 28 Dec 2022). 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 Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1 (time frame: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2022.