Dysport® Treatment of Urinary Incontinence in Adults Subj... | NCT02660138

NCT02660138

ID	Type	Description	Link
2015-003471-30	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
600 U Dysport® Group	Experimental	Biological: Botulinum toxin type A
600 U Dysport® Placebo Group	Placebo Comparator	Drug: Placebo
800 U Dysport® Group	Experimental	Biological: Botulinum toxin type A
800 U Dysport® Placebo Group	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botulinum toxin type A	Biological	600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points	600 U Dysport® Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle	The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The least square (LS) mean of the change in weekly number of UI episodes at 6 weeks after the first study treatment was calculated using a mixed model repeated measures (MMRM) analysis.	Baseline and Week 6 of DBPC Cycle

Secondary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 6 of DBPC Cycle	All subjects had a standardised urodynamic (filling cystometry) assessment at baseline (screening) and again at Week 6 to determine the MCC. The LS mean of the change in MCC at 6 weeks after the first study treatment was calculated using an analysis of covariance (ANCOVA).	Baseline and Week 6 of DBPC Cycle

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Ipsen Medical Director	Ipsen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
UAB School of Medicine Spain Rehabilitation Center (SRC)		Birmingham	Alabama	35249	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35400537	Derived	Kennelly M, Cruz F, Herschorn S, Abrams P, Onem K, Solomonov VK, Del Rosario Figueroa Coz E, Manu-Marin A, Giannantoni A, Thompson C, Vilain C, Volteau M, Denys P; Dysport CONTENT Program Group. Efficacy and Safety of AbobotulinumtoxinA in Patients with Neurogenic Detrusor Overactivity Incontinence Performing Regular Clean Intermittent Catheterization: Pooled Results from Two Phase 3 Randomized Studies (CONTENT1 and CONTENT2). Eur Urol. 2022 Aug;82(2):223-232. doi: 10.1016/j.eururo.2022.03.010. Epub 2022 Apr 7.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 millilitres (mL) divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 16, 2018	Apr 7, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Modified intention to treat (mITT) population: All randomised subjects who received at least 1 administration of study treatment. Subjects were analysed as randomised (planned treatment).

Arm/Group Information

ID	Title	Description
BG000	Placebo	Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
BG001	Dysport® 600 U	Subjects were administered Dysport® 600 U for the first study treatment administration on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
BG002	Dysport® 800 U	Subjects were administered Dysport® 800 U for the first study treatment administration on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00045.9± 13.15 BG00143.0± 12.38 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00038 BG00127 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Aetiology of NDO

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
SCI	BG00051 BG00149 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle

The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The least square (LS) mean of the change in weekly number of UI episodes at 6 weeks after the first study treatment was calculated using a mixed model repeated measures (MMRM) analysis.

mITT population: All randomised subjects who received at least 1 administration of study treatment. Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented.

Posted

Least Squares Mean

Standard Error

Weekly UI episodes

Baseline and Week 6 of DBPC Cycle

ID	Title	Description
OG000	Placebo	Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
OG001	Dysport® 600 U	Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
OG002	Dysport® 800 U	Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.

Units	Counts
Participants	OG00064 OG00162 OG00267

Title

Denominators

Categories

Title	Measurements
	OG000-12.7± 2.01 OG001-23.5± 2.04 OG002-24.9± 1.97

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO [SCI or MS], prior intradetrusor [Botulinum toxin [BTX]-naïve or BTX-non-naïve]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.	MMRM		0.0001		LS Mean Difference	-10.83			2-Sided	95	-16.36	-5.31					Superiority	If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025.

Secondary

Mean Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 6 of DBPC Cycle

All subjects had a standardised urodynamic (filling cystometry) assessment at baseline (screening) and again at Week 6 to determine the MCC. The LS mean of the change in MCC at 6 weeks after the first study treatment was calculated using an analysis of covariance (ANCOVA).

Posted

Least Squares Mean

Standard Error

Baseline and Week 6 of DBPC Cycle

ID	Title	Description
OG000	Placebo	Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
OG001	Dysport® 600 U	Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.

Secondary

Mean Change From Baseline in Maximum Detrusor Pressure (MDP) at Week 6 of DBPC Cycle

All subjects had a standardised urodynamic filling cystometry assessment at baseline (screening) and again at Week 6 to determine the MDP. The LS mean of the change in MDP at 6 weeks after the first study treatment was calculated using an ANCOVA.

Posted

Least Squares Mean

Standard Error

centimetres of water

Baseline and Week 6 of DBPC Cycle

ID	Title	Description
OG000	Placebo	Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
OG001	Dysport® 600 U	Subjects were administered Dysport® 600 U for the first study treatment administration on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.

Secondary

Mean Change From Baseline in Volume at First Involuntary Detrusor Contraction (Vol@1stIDC) at Week 6 of DBPC Cycle

All subjects had a standardised urodynamic (filling cystometry) assessment at baseline (screening) and again at Week 6 to determine the Vol@1stIDC which is the instilled volume when first IDC commences. Subjects who did not exhibit a post-treatment IDC at Week 6 had Vol@1stIDC imputed using the recorded corrected MCC volume at Week 6. The LS mean of the change in Vol@1stIDC at 6 weeks after the first study treatment was calculated using an ANCOVA.

Posted

Least Squares Mean

Standard Error

Baseline and Week 6 of DBPC Cycle

ID	Title	Description
OG000	Placebo	Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
OG001	Dysport® 600 U	Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.

Secondary

Number of Subjects With No Episodes of UI at Week 6 of DBPC Cycle

The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The number of subjects with no UI episodes at 6 weeks after the first study treatment was recorded and the percentage of subjects was also calculated from the total number of subjects with any number of UI events at Week 6.

mITT population: All randomised subjects who received at least 1 administration of study treatment . Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented.

Posted

Count of Participants

Participants

Baseline and Week 6 of DBPC Cycle

ID	Title	Description
OG000	Placebo	Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
OG001	Dysport® 600 U	Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.

Secondary

Number of Subjects With No IDCs During Storage at Week 6 of DBPC Cycle

All subjects had a standardised urodynamic filling cystometry assessment at baseline (screening) and again at Week 6 to determine the occurrence of IDCs. The number of subjects without IDCs at 6 weeks after the first study treatment was recorded and the percentage of subjects was also calculated from the total number of subjects with data available for analysis at Week 6.

Posted

Count of Participants

Participants

Baseline and Week 6 of DBPC Cycle

ID	Title	Description
OG000	Placebo	Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
OG001	Dysport® 600 U	Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.

Secondary

Mean Change From Baseline in Incontinence Quality of Life (I-QoL) Questionnaire Total Summary Score at Week 6 of DBPC Cycle

The I-QoL questionnaire is a validated, disease-specific questionnaire designed to measure the effect of UI on subjects' QoL. It consists of 22 items in 3 domains (avoidance and limiting behaviour, psychosocial impact and social embarrassment). Subjects used a 5-point response scale for each of the 22 items with values ranging from 1 (extremely) to 5 (not at all). The total summary score was transformed to a 100 point scale ranging from 0 to 100, with higher scores indicating a better QoL. The LS mean of the change in the I-QoL total summary score at 6 weeks after the first study treatment was calculated using a MMRM analysis.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline and Week 6 of DBPC Cycle

ID	Title	Description
OG000	Placebo	Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
OG001

Secondary

Number of Subjects With a UI Response at Improvement Levels ≥30%, ≥50%, and ≥75% at Week 6 of the DBPC Cycle

The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The number of baseline UI episodes was compared with the number of UI episodes at Week 6 to determine the level of response each subject reached, i.e. a decrease of ≥30%, ≥50% or ≥75% . The number of subjects showing an improvement of ≥30%, ≥50% and ≥75% were recorded and the percentage of subjects was also calculated from the total number of subjects with any number of UI events at Week 6.

mITT population: All randomised subjects who received at least 1 administration of study treatment . Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented.

Posted

Count of Participants

Participants

Baseline and Week 6 of DBPC Cycle

ID	Title	Description
OG000	Placebo	Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
OG001	Dysport® 600 U

Secondary

Mean Change From Baseline in Volume Per Void at Week 6 of DBPC Cycle

The volume per void was measured during one 24-hour period of the 7-day bladder diary. The LS mean of the change in volume per void at 6 weeks after the first study treatment was calculated using a MMRM analysis.

Posted

Least Squares Mean

Standard Error

Baseline and Week 6 of DBPC Cycle

ID	Title	Description
OG000	Placebo	Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
OG001	Dysport® 600 U	Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.

Secondary

Median Time Between Treatments

Duration of effect for time between treatments was calculated by: (the date of the first retreatment visit - date of first treatment administration in the DBPC cycle). The median number of days between treatments was determined based on the Kaplan-Meier method. Subjects with no retreatment were censored at the last visit.

mITT population: All randomised subjects who received at least 1 administration of study treatment. Subjects were analysed as randomised (planned treatment).

Posted

Median

Full Range

days

Day of first treatment (baseline) and day of retreatment, up to 2 years

ID	Title	Description
OG000	Placebo	Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
OG001	Dysport® 600 U	Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	76	8	76	23	76
EG001	Dysport® 600 U	Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	73	9	73	20	73
EG002	Dysport® 800 U	Subjects were administered Dysport® 800 U for on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	77	6	77	23	77

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ileus	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected73 at risk EG0020 events0 affected77 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected73 at risk EG0020 events0 affected77 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected76 at risk EG0015 events3 affected73 at risk EG0021 events1 affected77 at risk
Appendicitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected76 at risk EG0010 affected73 at risk EG0021 affected77 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0010 events0 affected73 at risk EG0021 affected77 at risk
Cystitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0010 events0 affected73 at risk EG0021 events1 affected77 at risk
Epididymitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected73 at risk EG0020 events0 affected77 at risk
Erysipelas	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0010 events0 affected73 at risk EG0021 events1 affected77 at risk
Osteomyelitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected73 at risk EG0020 events0 affected77 at risk
Pneumonia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected76 at risk EG0011 events1 affected73 at risk EG0020 events0 affected77 at risk
Bacteraemia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected76 at risk EG0010 events0 affected73 at risk EG0020 events0 affected77 at risk
Fournier's gangrene	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected76 at risk EG0010 events0 affected73 at risk EG0020 events0 affected77 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected73 at risk EG0020 events0 affected77 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected73 at risk EG0020 events0 affected77 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected76 at risk EG0010 events0 affected73 at risk EG0020 events0 affected77 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected76 at risk EG0010 events0 affected73 at risk EG0020 events0 affected77 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected76 at risk EG0010 events0 affected73 at risk EG0020 events0 affected77 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected73 at risk EG0020 events0 affected77 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected76 at risk EG0010 events0 affected73 at risk EG0020 events0 affected77 at risk
Metastases to abdominal cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected73 at risk EG0020 events0 affected77 at risk
Haematuria	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected73 at risk EG0021 events1 affected77 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected73 at risk EG0020 events0 affected77 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected76 at risk EG0010 events0 affected73 at risk EG0020 events0 affected77 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0010 events0 affected73 at risk EG0021 events1 affected77 at risk
Hypertension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected73 at risk EG0020 events0 affected77 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected73 at risk EG0020 events0 affected77 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected76 at risk EG0012 events2 affected73 at risk EG0021 events1 affected77 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected76 at risk EG0011 events1 affected73 at risk EG0020 events0 affected77 at risk
Pyrexia	General disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected76 at risk EG0012 events2 affected73 at risk EG0020 events0 affected77 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00026 events13 affected76 at risk EG00126 events13 affected73 at risk EG00227 events21 affected77 at risk
Influenza	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0010 events0 affected73 at risk EG0022 events2 affected77 at risk
Pharyngitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0012 events2 affected73 at risk EG0020 events0 affected77 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected76 at risk EG0011 events1 affected73 at risk EG0020 events0 affected77 at risk
Paraesthesia	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0012 events2 affected73 at risk EG0020 events0 affected77 at risk
Dizziness	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected76 at risk EG0011 events1 affected73 at risk EG0020 events0 affected77 at risk
Haematuria	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected76 at risk EG0013 events3 affected73 at risk EG0022 events2 affected77 at risk
Dysuria	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected76 at risk EG0012 events2 affected73 at risk EG0022 events2 affected77 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected76 at risk EG0012 events2 affected73 at risk EG0020 events0 affected77 at risk

This study was terminated early by the sponsor on 01 October 2018, due to low subject recruitment.

Certain Agreements

ID	Term
D014549	Urinary Incontinence
D053201	Urinary Bladder, Overactive

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D059411	Lower Urinary Tract Symptoms
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001745	Urinary Bladder Diseases

ID	Term
D019274	Botulinum Toxins, Type A
C542869	abobotulinumtoxinA

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes
D045726	Metalloproteases
D001426	Bacterial Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D001427	Bacterial Toxins
D014118	Toxins, Biological
D001685	Biological Factors