A Phase 3 interventional study of BOTOX® in Urinary Incontinence, Urinary Bladder and Overactive, sponsored by Allergan. Terminated at 39 sites in 13 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-12-28.
Sponsored by Allergan · Phase 3, Interventional, and Treatment
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 56 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
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Exclusion Criteria
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.
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.
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.
Biological: BOTOX®
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.
Also known as: Botulinum Toxin Type A
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.
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 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.
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
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.
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
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.
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)
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.
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)
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.
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"
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.
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"
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.
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"
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.
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
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.
Time frame: 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.
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
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.
Time frame: From the day of BOTOX treatment in Treatment Cycle 1 to the qualification for retreatment
Number of Participants With Treatment Emergent Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Time frame: From the first dose of study drug until the last dose, up to 147 weeks
| Milestone | Botox 25 U | Botox 50 U | Botox 100 U |
|---|---|---|---|
| Started | 19 | 18 | 19 |
| Received any treatment | 19 | 17 | 19 |
| Actual treatment received in cycle 1 | 18 | 17 | 20 |
| Actual treatment received in cycle 2 | 1 | 17 | 28 |
| Actual treatment received in cycle 3 | 2 | 7 | 13 |
| Actual treatment received in cycle 4 | 0 | 1 | 3 |
| Completed | 12 | 12 | 9 |
| Not completed | 7 | 6 | 10 |
| Withdrew: Other, not specified | 4 | 2 | 3 |
| Withdrew: Lack of efficacy | 2 | 1 | 3 |
| Withdrew: Withdrawal by subject | 0 | 1 | 2 |
| Withdrew: Adverse event | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 | 2 |
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.
| urinary incontinence episodes per day | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) |
|---|---|---|---|
| Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1 | -1.37 ± 0.801 | -0.97 ± 0.811 | -2.35 ± 0.746 |
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.
| micturition episodes per day | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) |
|---|---|---|---|
| Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Micturition Episodes | -1.84 ± 1.027 | 0.31 ± 1.014 | -1.02 ± 0.983 |
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.
| urgency episodes per day | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) |
|---|---|---|---|
| Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Urgency Episodes | -1.85 ± 1.014 | -1.78 ± 0.998 | -2.18 ± 0.945 |
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.
| percentage of participants | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) |
|---|---|---|---|
| Baseline-0 nights | 22.2 | 52.9 | 35.0 |
| Baseline-1 night | 27.8 | 11.8 | 15.0 |
| Baseline-2 nights | 50.0 | 35.3 | 50.0 |
| Week 12-0 nights | 50.0 | 76.5 | 50.0 |
| Week 12-1 night | 22.2 | 5.9 | 15.0 |
| Week 12-2 nights | 27.8 | 17.6 | 35.0 |
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.
| mL | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) |
|---|---|---|---|
| Change From Study Baseline in the Daily Average Volume Voided Per Micturition (mL) | -9.17 ± 15.924 | 24.94 ± 17.047 | 26.16 ± 15.900 |
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.
| units on a scale | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) |
|---|---|---|---|
| Change From Study Baseline in Pediatric Urinary Incontinence Quality of Life Total Score (PinQ) | -6.96 ± 2.841 | -5.11 ± 3.243 | -8.28 ± 2.979 |
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.
| units on a scale | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) |
|---|---|---|---|
| Change From Study Baseline in PinQ Item 'I am Worried That People Might Think my Clothes Smell Like Pee" | -0.06 ± 0.238 | -0.37 ± 0.273 | -0.09 ± 0.251 |
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.
| units on a scale | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) |
|---|---|---|---|
| Change From Study Baseline in PinQ Item 'My Bladder Problem Makes me Feel Bad About Myself" | -0.54 ± 0.209 | -0.15 ± 0.238 | -0.24 ± 0.220 |
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.
| units on a scale | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) |
|---|---|---|---|
| Change From Study Baseline in PinQ Item 'I Miss Out on Being With Friends Because of my Bladder Problems" | -0.39 ± 0.193 | -0.24 ± 0.218 | -0.27 ± 0.201 |
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.
| percentage of participants | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) |
|---|---|---|---|
| Percentage of Participants With a Positive Treatment Response in the Modified Treatment Benefit Scale | 52.9 (27.81 to 77.02) | 70.6 (44.04 to 89.69) | 68.4 (43.45 to 87.42) |
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.
| weeks | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) |
|---|---|---|---|
| Time to Participant's First Request for Retreatment | 16.6 (12.71 to 25.29) | 17.6 (11.29 to 38.57) | 21.3 (12.86 to 30.14) |
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.
| weeks | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) |
|---|---|---|---|
| Time to Participant's Qualification for Retreatment | 22.5 (13.57 to 36.29) | 18.1 (12.29 to 52.57) | 24.1 (12.86 to 41.57) |
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
| Participants | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) |
|---|---|---|---|
| Cycle 1 | 13 | 12 | 14 |
| Cycle 2 | 1 | 13 | 18 |
| Cycle 3 | 1 | 3 | 8 |
| Cycle 4 | — | 1 | 1 |
Collected over All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 25 U BOTOX All | 0/18 (0%) | 1/18 (5.6%) | 12/18 (66.7%) |
| 50 U BOTOX All | 0/29 (0%) | 0/29 (0%) | 23/29 (79.3%) |
| 100 U BOTOX All | 0/33 (0%) | 1/33 (3%) | 24/33 (72.7%) |
| 25 U BOTOX Cycle 1 | 0/18 (0%) | 1/18 (5.6%) | 12/18 (66.7%) |
| 50 U BOTOX Cycle 1 | 0/17 (0%) | 0/17 (0%) | 12/17 (70.6%) |
| 100 U BOTOX Cycle 1 | 0/20 (0%) | 0/20 (0%) | 14/20 (70%) |
| All BOTOX Cycle 1 | 0/55 (0%) | 1/55 (1.8%) | 38/55 (69.1%) |
| 25 U BOTOX Cycle 2 | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| 50 U BOTOX Cycle 2 | 0/17 (0%) | 0/17 (0%) | 13/17 (76.5%) |
| 100 U BOTOX Cycle 2 | 0/28 (0%) | 1/28 (3.6%) | 18/28 (64.3%) |
| All BOTOX Cycle 2 | 0/46 (0%) | 1/46 (2.2%) | 32/46 (69.6%) |
| 25 U BOTOX Cycle 3 | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| 50 U BOTOX Cycle 3 | 0/7 (0%) | 0/7 (0%) | 3/7 (42.9%) |
| 100 U BOTOX Cycle 3 | 0/13 (0%) | 1/13 (7.7%) | 8/13 (61.5%) |
| All BOTOX Cycle 3 | 0/22 (0%) | 1/22 (4.5%) | 12/22 (54.5%) |
| 25 U BOTOX Cycle 4 | — | — | — |
| 50 U BOTOX Cycle 4 | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| 100 U BOTOX Cycle 4 | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| All BOTOX Cycle 4 | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| Event | 25 U BOTOX All | 50 U BOTOX All | 100 U BOTOX All | 25 U BOTOX Cycle 1 | 50 U BOTOX Cycle 1 | 100 U BOTOX Cycle 1 | All BOTOX Cycle 1 | 25 U BOTOX Cycle 2 | 50 U BOTOX Cycle 2 | 100 U BOTOX Cycle 2 | All BOTOX Cycle 2 | 25 U BOTOX Cycle 3 | 50 U BOTOX Cycle 3 | 100 U BOTOX Cycle 3 | All BOTOX Cycle 3 | 25 U BOTOX Cycle 4 | 50 U BOTOX Cycle 4 | 100 U BOTOX Cycle 4 | All BOTOX Cycle 4 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MALAISEGeneral disorders | 0/18 | 0/29 | 0/33 | 0/18 | 0/17 | 0/20 | 0/55 | 0/1 | 0/17 | 0/28 | 0/46 | 0/2 | 0/7 | 1/13 | 1/22 | — | 0/1 | 0/3 | 0/4 |
| PALLORVascular disorders | 0/18 | 0/29 | 0/33 | 0/18 | 0/17 | 0/20 | 0/55 | 0/1 | 0/17 | 0/28 | 0/46 | 0/2 | 0/7 | 1/13 | 1/22 | — | 0/1 | 0/3 | 0/4 |
| ABDOMINAL PAINGastrointestinal disorders | 1/18 | 0/29 | 0/33 | 1/18 | 0/17 | 0/20 | 1/55 | 0/1 | 0/17 | 0/28 | 0/46 | 0/2 | 0/7 | 0/13 | 0/22 | — | 0/1 | 0/3 | 0/4 |
| BACK PAINMusculoskeletal and connective tissue disorders | 1/18 | 0/29 | 0/33 | 1/18 | 0/17 | 0/20 | 1/55 | 0/1 | 0/17 | 0/28 | 0/46 | 0/2 | 0/7 | 0/13 | 0/22 | — | 0/1 | 0/3 | 0/4 |
| SOCIAL PROBLEMSocial circumstances | 1/18 | 0/29 | 0/33 | 1/18 | 0/17 | 0/20 | 1/55 | 0/1 | 0/17 | 0/28 | 0/46 | 0/2 | 0/7 | 0/13 | 0/22 | — | 0/1 | 0/3 | 0/4 |
| ANXIETY DISORDERPsychiatric disorders | 0/18 | 0/29 | 1/33 | 0/18 | 0/17 | 0/20 | 0/55 | 0/1 | 0/17 | 1/28 | 1/46 | 0/2 | 0/7 | 0/13 | 0/22 | — | 0/1 | 0/3 | 0/4 |
| Event | 25 U BOTOX All | 50 U BOTOX All | 100 U BOTOX All | 25 U BOTOX Cycle 1 | 50 U BOTOX Cycle 1 | 100 U BOTOX Cycle 1 | All BOTOX Cycle 1 | 25 U BOTOX Cycle 2 | 50 U BOTOX Cycle 2 | 100 U BOTOX Cycle 2 | All BOTOX Cycle 2 | 25 U BOTOX Cycle 3 | 50 U BOTOX Cycle 3 | 100 U BOTOX Cycle 3 | All BOTOX Cycle 3 | 25 U BOTOX Cycle 4 | 50 U BOTOX Cycle 4 | 100 U BOTOX Cycle 4 | All BOTOX Cycle 4 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CHRONIC FATIGUE SYNDROMEGeneral disorders | 0/18 | 0/29 | 0/33 | 0/18 | 0/17 | 0/20 | 0/55 | 1/1 | 0/17 | 0/28 | 1/46 | 0/2 | 0/7 | 0/13 | 0/22 | — | 0/1 | 0/3 | 0/4 |
| URINE LEUKOCYTE ESTERASE POSITIVEInvestigations | 0/18 | 0/29 | 0/33 | 0/18 | 0/17 | 0/20 | 0/55 | 0/1 | 0/17 | 0/28 | 0/46 | 0/2 | 0/7 | 0/13 | 0/22 | — | 1/1 | 0/3 | 1/4 |
| ANAEMIABlood and lymphatic system disorders | 0/18 | 0/29 | 0/33 | 0/18 | 0/17 | 0/20 | 0/55 | 0/1 | 0/17 | 0/28 | 0/46 | 1/2 | 0/7 | 0/13 | 1/22 | — | 0/1 | 0/3 | 0/4 |
| CONSTIPATIONGastrointestinal disorders | 0/18 | 1/29 | 0/33 | 0/18 | 1/17 | 0/20 | 1/55 | 0/1 | 0/17 | 0/28 | 0/46 | 1/2 | 0/7 | 0/13 | 1/22 | — | 0/1 | 0/3 | 0/4 |
| FUNGAL SKIN INFECTIONInfections and infestations | 0/18 | 0/29 | 0/33 | 0/18 | 0/17 | 0/20 | 0/55 | 0/1 | 0/17 | 0/28 | 0/46 | 1/2 | 0/7 | 0/13 | 1/22 | — | 0/1 | 0/3 | 0/4 |
| DIZZINESSNervous system disorders | 0/18 | 2/29 | 0/33 | 0/18 | 1/17 | 0/20 | 1/55 | 0/1 | 1/17 | 0/28 | 1/46 | 1/2 | 0/7 | 0/13 | 1/22 | — | 0/1 | 0/3 | 0/4 |
| DYSURIARenal and urinary disorders | 2/18 | 5/29 | 3/33 | 2/18 | 1/17 | 2/20 | 5/55 | 0/1 | 4/17 | 2/28 | 6/46 | 1/2 | 0/7 | 0/13 | 1/22 | — | 0/1 | 0/3 | 0/4 |
| PERIPHERAL SWELLINGGeneral disorders | 0/18 | 0/29 | 1/33 | 0/18 | 0/17 | 1/20 | 1/55 | 0/1 | 0/17 | 0/28 | 0/46 | 0/2 | 0/7 | 0/13 | 0/22 | — | 0/1 | 1/3 | 1/4 |
| RESIDUAL URINE VOLUMEInvestigations | 0/18 | 0/29 | 0/33 | 0/18 | 0/17 | 0/20 | 0/55 | 0/1 | 0/17 | 0/28 | 0/46 | 0/2 | 0/7 | 0/13 | 0/22 | — | 0/1 | 1/3 | 1/4 |
| MUSCULOSKELETAL PAINMusculoskeletal and connective tissue disorders | 0/18 | 0/29 | 0/33 | 0/18 | 0/17 | 0/20 | 0/55 | 0/1 | 0/17 | 0/28 | 0/46 | 0/2 | 0/7 | 0/13 | 0/22 | — | 0/1 | 1/3 | 1/4 |
The BOTOX-treated population (all participants enrolled into the study who received at least 1 BOTOX treatment) according to the dose received in the first treatment cycle.
| Age, Categorical(Participants) | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) | Total |
|---|---|---|---|---|
| <=18 years | 18 | 17 | 20 | 55 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) | Total |
|---|---|---|---|---|
| Mean | 13.7 ± 1.49 | 14.3 ± 1.86 | 14.0 ± 1.75 | 14.0 ± 1.69 |
| Sex: Female, Male(Participants) | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) | Total |
|---|---|---|---|---|
| Female | 16 | 17 | 14 | 47 |
| Male | 2 | 0 | 6 | 8 |
| Race/Ethnicity, Customized(Participants) | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) | Total |
|---|---|---|---|---|
| White | 12 | 12 | 17 | 41 |
| Black or African American | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 0 | 1 |
| Hispanic | 0 | 0 | 0 | 0 |
| Other | 1 | 1 | 1 | 3 |
| Not reported | 2 | 1 | 1 | 4 |
| Unknown | 3 | 2 | 1 | 6 |
| Daily Frequency of Daytime Urinary Incontinence Episodes(number of episodes) | BOTOX 25 U (BOTOX-Treated Population) | BOTOX 50 U (BOTOX-Treated Population) | BOTOX 100 U (BOTOX-Treated Population) | Total |
|---|---|---|---|---|
| Mean | 5.29 ± 3.447 | 3.54 ± 2.696 | 3.64 ± 2.951 | 4.15 ± 3.100 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Csr
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