Trial Outcomes & Findings for Sling vs Botox for Mixed Incontinence (NCT NCT04171531)

Last Updated: 2025-06-03

Results Overview

The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

150 participants

Primary outcome timeframe

3, 6, 9, and 12 Months

Results posted on

2025-06-03

Participant Flow

Participant milestones

Participant milestones
Measure	Botox A Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling Mid-Urethral Sling for treatment of urinary incontinence
Overall Study STARTED	72	78
Overall Study Received Treatment	71	69
Overall Study Provided Follow-up Data	71	66
Overall Study COMPLETED	66	63
Overall Study NOT COMPLETED	6	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Botox A Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling Mid-Urethral Sling for treatment of urinary incontinence
Overall Study Lost to Follow-up	4	5
Overall Study Consent only through 6 months	1	1
Overall Study Insurance did not cover procedure	0	1
Overall Study Physician Decision	0	3
Overall Study Withdrawal by Subject	1	5

Baseline Characteristics

Sling vs Botox for Mixed Incontinence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont	Total n=137 Participants Total of all reporting groups
Age, Continuous	59.1 years STANDARD_DEVIATION 11.4 • n=5 Participants	59 years STANDARD_DEVIATION 11.7 • n=7 Participants	59 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex/Gender, Customized Female	71 Participants n=5 Participants	66 Participants n=7 Participants	137 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	55 Participants n=5 Participants	54 Participants n=7 Participants	109 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latina	15 Participants n=5 Participants	6 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic/Not Latina	56 Participants n=5 Participants	59 Participants n=7 Participants	115 Participants n=5 Participants
Race/Ethnicity, Customized Unknown/Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Menopausal Status, Customized Not sure	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Menopausal Status, Customized Post-menopausal	56 Participants n=5 Participants	49 Participants n=7 Participants	105 Participants n=5 Participants
Menopausal Status, Customized Pre-menopausal	7 Participants n=5 Participants	14 Participants n=7 Participants	21 Participants n=5 Participants
Education 4-Year College Degree	21 Participants n=5 Participants	11 Participants n=7 Participants	32 Participants n=5 Participants
Education Associate College Degree	17 Participants n=5 Participants	13 Participants n=7 Participants	30 Participants n=5 Participants
Education Graduate Degree	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Education High School/GED	19 Participants n=5 Participants	29 Participants n=7 Participants	48 Participants n=5 Participants
Education Less than High School	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Education Unknown/Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3, 6, 9, and 12 Months

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
UDI-LF Total Score Change From Baseline 3.0	-82.2 units on a scale Interval -100.0 to -64.4	-84.6 units on a scale Interval -101.0 to -68.3
UDI-LF Total Score Change From Baseline 6.0	-74.9 units on a scale Interval -93.6 to -56.1	-89.1 units on a scale Interval -104.7 to -73.5
UDI-LF Total Score Change From Baseline 9.0	-63.1 units on a scale Interval -81.8 to -44.5	-85.6 units on a scale Interval -102.7 to -68.6
UDI-LF Total Score Change From Baseline 12.0	-67.7 units on a scale Interval -85.7 to -49.8	-89.2 units on a scale Interval -107.5 to -70.9

SECONDARY outcome

Timeframe: 3, 6, 9, and 12 Months

The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Stress subscale has a range from 0 to 100 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
UDI-LF Stress Score Change From Baseline 3.0	-27.9 units on a scale Interval -37.7 to -18.1	-46.4 units on a scale Interval -55.4 to -37.3
UDI-LF Stress Score Change From Baseline 6.0	-30.2 units on a scale Interval -39.6 to -20.9	-45.1 units on a scale Interval -53.6 to -36.7
UDI-LF Stress Score Change From Baseline 9.0	-20.2 units on a scale Interval -30.1 to -10.4	-42.3 units on a scale Interval -53.1 to -31.4
UDI-LF Stress Score Change From Baseline 12.0	-24.3 units on a scale Interval -34.6 to -14.1	-44.4 units on a scale Interval -53.8 to -35.1

SECONDARY outcome

Timeframe: 3, 6, 9, and 12 Months

The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Irritative subscale has a range from 0 to 100 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
UDI-LF Irritative Score Change From Baseline 6.0	-35.8 units on a scale Interval -43.3 to -28.3	-30.6 units on a scale Interval -37.4 to -23.8
UDI-LF Irritative Score Change From Baseline 3.0	-40.8 units on a scale Interval -47.3 to -34.2	-28.1 units on a scale Interval -35.6 to -20.6
UDI-LF Irritative Score Change From Baseline 9.0	-32.7 units on a scale Interval -40.5 to -25.0	-30.8 units on a scale Interval -38.8 to -22.7
UDI-LF Irritative Score Change From Baseline 12.0	-31.6 units on a scale Interval -39.0 to -24.2	-33 units on a scale Interval -41.4 to -24.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Obstructive subscale has a range from 0 to 100 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
UDI-LF Obstructive Score Change From Baseline 6.0	-8.9 units on a scale Interval -13.8 to -4.0	-13.4 units on a scale Interval -17.5 to -9.3
UDI-LF Obstructive Score Change From Baseline 9.0	-10.2 units on a scale Interval -15.7 to -4.7	-12.6 units on a scale Interval -17.0 to -8.2
UDI-LF Obstructive Score Change From Baseline 12.0	-11.8 units on a scale Interval -16.4 to -7.2	-11.7 units on a scale Interval -16.5 to -6.9
UDI-LF Obstructive Score Change From Baseline 3.0	-13.5 units on a scale Interval -18.8 to -8.1	-10.1 units on a scale Interval -14.6 to -5.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

Based on data collected from participant-completed diaries, average daily frequency of combined mixed stress/urge and non-categorized incontinence epsiodes. The outcome variable is computed as the difference in number of episodes at 3, 6, and 12 months and the number of episodes at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=65 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=65 Participants Mid-Urethral Sling for treatment of urinary incont
Average Daily Frequency of Combined Mixed Stress/Urge and Non-categorized Incontinence Epsiodes Change From Baseline 12.0	-0.2 incontinence episodes/day Interval -0.6 to 0.2	-0.7 incontinence episodes/day Interval -1.3 to -0.2
Average Daily Frequency of Combined Mixed Stress/Urge and Non-categorized Incontinence Epsiodes Change From Baseline 3.0	-0.4 incontinence episodes/day Interval -0.9 to 0.0	-0.4 incontinence episodes/day Interval -0.9 to 0.1
Average Daily Frequency of Combined Mixed Stress/Urge and Non-categorized Incontinence Epsiodes Change From Baseline 6.0	-0.2 incontinence episodes/day Interval -0.5 to 0.1	-0.7 incontinence episodes/day Interval -1.1 to -0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

Based on data collected from participant-completed diaries, average daily frequency of all incontinence epsiodes. The outcome variable is computed as the difference in number of episodes at 3, 6, and 12 months and the number of episodes at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=67 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=65 Participants Mid-Urethral Sling for treatment of urinary incont
Average Daily Frequency of All Incontinence Epsiodes Change From Baseline 3.0	-4 incontinence episodes/day Interval -4.9 to -3.2	-3.9 incontinence episodes/day Interval -5.0 to -2.8
Average Daily Frequency of All Incontinence Epsiodes Change From Baseline 6.0	-3.2 incontinence episodes/day Interval -3.9 to -2.4	-4.1 incontinence episodes/day Interval -5.2 to -3.1
Average Daily Frequency of All Incontinence Epsiodes Change From Baseline 12.0	-3.6 incontinence episodes/day Interval -4.7 to -2.6	-4.5 incontinence episodes/day Interval -5.8 to -3.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

Based on data collected from participant-completed diaries, average daily frequency of diurnal voids. The outcome variable is computed as the difference in number of voids at 3, 6, and 12 months and the number of voids at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=67 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=65 Participants Mid-Urethral Sling for treatment of urinary incont
Average Daily Frequency of Diurnal Voids Change From Baseline 3.0	-1.2 diurnal voids/day Interval -1.7 to -0.7	0 diurnal voids/day Interval -0.6 to 0.6
Average Daily Frequency of Diurnal Voids Change From Baseline 6.0	-0.8 diurnal voids/day Interval -1.3 to -0.2	-0.2 diurnal voids/day Interval -0.9 to 0.6
Average Daily Frequency of Diurnal Voids Change From Baseline 12.0	-0.8 diurnal voids/day Interval -1.5 to -0.2	-0.3 diurnal voids/day Interval -1.0 to 0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

Based on data collected from participant-completed diaries, average daily frequency of nocturnal voids. The outcome variable is computed as the difference in number of voids at 3, 6, and 12 months and the number of voids at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=66 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=65 Participants Mid-Urethral Sling for treatment of urinary incont
Average Daily Frequency of Nocturnal Voids Change From Baseline 3.0	-0.5 nocturnal voids/day Interval -0.7 to -0.2	-0.5 nocturnal voids/day Interval -0.8 to -0.1
Average Daily Frequency of Nocturnal Voids Change From Baseline 6.0	-0.3 nocturnal voids/day Interval -0.6 to -0.1	-0.2 nocturnal voids/day Interval -0.5 to 0.2
Average Daily Frequency of Nocturnal Voids Change From Baseline 12.0	-0.4 nocturnal voids/day Interval -0.7 to -0.1	-0.4 nocturnal voids/day Interval -0.9 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

Based on data collected from participant-completed diaries, average daily frequency of all voids. The outcome variable is computed as the difference in number of voids at 3, 6, and 12 months and the number of voids at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=67 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=65 Participants Mid-Urethral Sling for treatment of urinary incont
Average Daily Frequency of All Voids Change From Baseline 3.0	-1.6 voids/day Interval -2.2 to -1.0	-0.4 voids/day Interval -1.1 to 0.2
Average Daily Frequency of All Voids Change From Baseline 6.0	-1.1 voids/day Interval -1.7 to -0.5	-0.4 voids/day Interval -1.1 to 0.4
Average Daily Frequency of All Voids Change From Baseline 12.0	-1.2 voids/day Interval -2.0 to -0.5	-0.7 voids/day Interval -1.6 to 0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

Based on data collected from participant-completed diaries at baseline and 3, 6, and 12 months, for participants with \>8 voids at baseline, the outcome is calculated as Yes=no more than 8 voids noted at the time point, No=Otherwise

Outcome measures

Outcome measures
Measure	Botox A n=43 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=40 Participants Mid-Urethral Sling for treatment of urinary incont
Normalization of Voiding Frequency 6.0 · No	17 Participants	25 Participants
Normalization of Voiding Frequency 6.0 · Yes	18 Participants	10 Participants
Normalization of Voiding Frequency 12.0 · No	13 Participants	21 Participants
Normalization of Voiding Frequency 3.0 · No	17 Participants	24 Participants
Normalization of Voiding Frequency 3.0 · Yes	23 Participants	13 Participants
Normalization of Voiding Frequency 12.0 · Yes	24 Participants	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

Based on data collected from participant-completed diaries at baseline and 3, 6, and 12 months, the outcome is calculated as Yes=at least 50% reduction in the number of voids between the timepoint and baseline, No=Otherwise

Outcome measures

Outcome measures
Measure	Botox A n=67 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=65 Participants Mid-Urethral Sling for treatment of urinary incont
Improvement of 50% or More in Voiding Frequency Post Baseline 3.0 · No	60 Participants	61 Participants
Improvement of 50% or More in Voiding Frequency Post Baseline 3.0 · Yes	1 Participants	0 Participants
Improvement of 50% or More in Voiding Frequency Post Baseline 6.0 · No	53 Participants	59 Participants
Improvement of 50% or More in Voiding Frequency Post Baseline 6.0 · Yes	0 Participants	1 Participants
Improvement of 50% or More in Voiding Frequency Post Baseline 12.0 · No	50 Participants	54 Participants
Improvement of 50% or More in Voiding Frequency Post Baseline 12.0 · Yes	3 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

Based on data collected from participant-completed diaries at baseline and 3, 6, and 12 months, the outcome is calculated as Yes=greater than baseline number of voids at the time point or with greater than 8 voids at the time point, No=Otherwise

Outcome measures

Outcome measures
Measure	Botox A n=67 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=65 Participants Mid-Urethral Sling for treatment of urinary incont
Worsening Voiding Frequency Post Baseline 3.0 · No	49 Participants	39 Participants
Worsening Voiding Frequency Post Baseline 3.0 · Yes	12 Participants	22 Participants
Worsening Voiding Frequency Post Baseline 6.0 · No	36 Participants	32 Participants
Worsening Voiding Frequency Post Baseline 6.0 · Yes	17 Participants	28 Participants
Worsening Voiding Frequency Post Baseline 12.0 · No	37 Participants	34 Participants
Worsening Voiding Frequency Post Baseline 12.0 · Yes	16 Participants	22 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.5 Months (2 Weeks) and 3, 6, and 12 Months

EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The visual analog scale (VAS) score ranges from 0 to 100 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=68 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=64 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline EQ-5D Visual Analog Score 3.0	2.2 units on a scale Interval -2.1 to 6.5	6.7 units on a scale Interval 1.9 to 11.5
Change From Baseline EQ-5D Visual Analog Score 6.0	1.5 units on a scale Interval -2.9 to 5.9	7.1 units on a scale Interval 3.0 to 11.3
Change From Baseline EQ-5D Visual Analog Score 9.0	1.4 units on a scale Interval -3.6 to 6.4	6.9 units on a scale Interval 2.8 to 11.1
Change From Baseline EQ-5D Visual Analog Score 0.5	3.1 units on a scale Interval -0.6 to 6.8	9.3 units on a scale Interval 4.7 to 13.8
Change From Baseline EQ-5D Visual Analog Score 12.0	1.6 units on a scale Interval -2.7 to 5.8	7.4 units on a scale Interval 2.3 to 12.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.5 Months (2 Weeks) and 3, 6, and 12 Months

EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The index score ranges from 0 to 1 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=70 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=64 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline EQ-5D Index Score 0.5	0 units on a scale Interval 0.0 to 0.0	0 units on a scale Interval 0.0 to 0.0
Change From Baseline EQ-5D Index Score 3.0	0 units on a scale Interval 0.0 to 0.1	0 units on a scale Interval 0.0 to 0.1
Change From Baseline EQ-5D Index Score 6.0	0 units on a scale Interval 0.0 to 0.1	0 units on a scale Interval 0.0 to 0.1
Change From Baseline EQ-5D Index Score 9.0	0 units on a scale Interval -0.1 to 0.0	0 units on a scale Interval 0.0 to 0.1
Change From Baseline EQ-5D Index Score 12.0	0 units on a scale Interval 0.0 to 0.1	0 units on a scale Interval 0.0 to 0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Physical Activity score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline IIQ-LF Physical Activity Score 3.0	-19.5 units on a scale Interval -27.1 to -12.0	-20.3 units on a scale Interval -28.0 to -12.6
Change From Baseline IIQ-LF Physical Activity Score 6.0	-20.7 units on a scale Interval -26.2 to -15.2	-21.1 units on a scale Interval -28.5 to -13.8
Change From Baseline IIQ-LF Physical Activity Score 9.0	-16.9 units on a scale Interval -23.2 to -10.6	-21.2 units on a scale Interval -29.0 to -13.4
Change From Baseline IIQ-LF Physical Activity Score 12.0	-18.1 units on a scale Interval -24.5 to -11.7	-25.3 units on a scale Interval -32.9 to -17.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Travel score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline IIQ-LF Travel Score 12.0	-19.7 units on a scale Interval -26.2 to -13.3	-28.1 units on a scale Interval -36.7 to -19.6
Change From Baseline IIQ-LF Travel Score 3.0	-19.6 units on a scale Interval -27.6 to -11.7	-22.2 units on a scale Interval -30.5 to -13.9
Change From Baseline IIQ-LF Travel Score 6.0	-23.3 units on a scale Interval -29.4 to -17.1	-25.4 units on a scale Interval -33.7 to -17.1
Change From Baseline IIQ-LF Travel Score 9.0	-14.3 units on a scale Interval -21.0 to -7.7	-25.8 units on a scale Interval -34.5 to -17.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Social Relationship score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline IIQ-LF Social/Relationships Score 3.0	-15.7 units on a scale Interval -22.6 to -8.7	-18.9 units on a scale Interval -26.8 to -11.0
Change From Baseline IIQ-LF Social/Relationships Score 6.0	-16.9 units on a scale Interval -22.8 to -11.0	-20.3 units on a scale Interval -27.8 to -12.8
Change From Baseline IIQ-LF Social/Relationships Score 9.0	-10.3 units on a scale Interval -15.8 to -4.7	-19.9 units on a scale Interval -27.8 to -12.0
Change From Baseline IIQ-LF Social/Relationships Score 12.0	-15.7 units on a scale Interval -21.8 to -9.5	-22.3 units on a scale Interval -30.7 to -13.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Emotional Health score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline IIQ-LF Emotional Health Score 3.0	-17.7 units on a scale Interval -24.8 to -10.6	-19.5 units on a scale Interval -26.0 to -12.9
Change From Baseline IIQ-LF Emotional Health Score 6.0	-20.2 units on a scale Interval -26.5 to -13.9	-21.5 units on a scale Interval -28.3 to -14.8
Change From Baseline IIQ-LF Emotional Health Score 9.0	-12.5 units on a scale Interval -19.4 to -5.6	-19.7 units on a scale Interval -26.0 to -13.5
Change From Baseline IIQ-LF Emotional Health Score 12.0	-17.5 units on a scale Interval -24.5 to -10.5	-26.8 units on a scale Interval -35.2 to -18.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Total score ranges from 0 to 400 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline IIQ-LF Total Score 3.0	-72.9 units on a scale Interval -99.5 to -46.2	-80.8 units on a scale Interval -108.4 to -53.2
Change From Baseline IIQ-LF Total Score 6.0	-81.1 units on a scale Interval -101.3 to -60.9	-88.4 units on a scale Interval -115.4 to -61.4
Change From Baseline IIQ-LF Total Score 9.0	-54 units on a scale Interval -75.7 to -32.2	-86.6 units on a scale Interval -113.9 to -59.3
Change From Baseline IIQ-LF Total Score 12.0	-71 units on a scale Interval -93.4 to -48.6	-102.5 units on a scale Interval -133.1 to -71.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Symptom Severity score ranges from 0 to 100 with higher score indicating worse quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline OABq-LF Symptom Severity Score 3.0	-41 units on a scale Interval -47.9 to -34.0	-28.7 units on a scale Interval -36.6 to -20.7
Change From Baseline OABq-LF Symptom Severity Score 6.0	-34.3 units on a scale Interval -41.0 to -27.6	-32 units on a scale Interval -39.6 to -24.3
Change From Baseline OABq-LF Symptom Severity Score 9.0	-26.7 units on a scale Interval -33.9 to -19.4	-28.8 units on a scale Interval -37.5 to -20.1
Change From Baseline OABq-LF Symptom Severity Score 12.0	-30.6 units on a scale Interval -38.3 to -22.8	-36.1 units on a scale Interval -44.3 to -27.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Coping score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline OABq-LF Coping Score 3.0	29.7 units on a scale Interval 21.7 to 37.8	29.5 units on a scale Interval 21.9 to 37.1
Change From Baseline OABq-LF Coping Score 6.0	24.3 units on a scale Interval 17.2 to 31.4	29.8 units on a scale Interval 22.0 to 37.5
Change From Baseline OABq-LF Coping Score 9.0	18.8 units on a scale Interval 11.8 to 25.8	26.4 units on a scale Interval 18.0 to 34.9
Change From Baseline OABq-LF Coping Score 12.0	24.7 units on a scale Interval 17.9 to 31.5	34.4 units on a scale Interval 25.6 to 43.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Concern score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline OABq-LF Concern Score 3.0	32.3 units on a scale Interval 24.6 to 40.0	29.6 units on a scale Interval 22.3 to 36.9
Change From Baseline OABq-LF Concern Score 6.0	26.1 units on a scale Interval 19.7 to 32.5	31.2 units on a scale Interval 23.7 to 38.7
Change From Baseline OABq-LF Concern Score 9.0	16.7 units on a scale Interval 9.2 to 24.2	28.2 units on a scale Interval 20.3 to 36.1
Change From Baseline OABq-LF Concern Score 12.0	24.5 units on a scale Interval 16.8 to 32.2	35.6 units on a scale Interval 27.1 to 44.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Sleep score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline OABq-LF Sleep Score 3.0	23.8 units on a scale Interval 16.3 to 31.3	20.7 units on a scale Interval 12.4 to 29.0
Change From Baseline OABq-LF Sleep Score 6.0	21.6 units on a scale Interval 14.4 to 28.8	18.4 units on a scale Interval 10.8 to 25.9
Change From Baseline OABq-LF Sleep Score 9.0	15.6 units on a scale Interval 8.4 to 22.7	19 units on a scale Interval 11.4 to 26.7
Change From Baseline OABq-LF Sleep Score 12.0	16.8 units on a scale Interval 9.3 to 24.3	19.8 units on a scale Interval 9.7 to 29.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Social score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline OABq-LF Social Score 3.0	15.1 units on a scale Interval 8.7 to 21.5	20 units on a scale Interval 13.0 to 27.0
Change From Baseline OABq-LF Social Score 6.0	11.8 units on a scale Interval 5.5 to 18.0	19.6 units on a scale Interval 13.4 to 25.8
Change From Baseline OABq-LF Social Score 9.0	4.8 units on a scale Interval -0.5 to 10.1	18.4 units on a scale Interval 10.9 to 26.0
Change From Baseline OABq-LF Social Score 12.0	11 units on a scale Interval 4.7 to 17.4	21 units on a scale Interval 13.6 to 28.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF HRQL score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline OABq-LF HRQL Total Score 3.0	26.4 units on a scale Interval 19.8 to 33.0	25.9 units on a scale Interval 19.2 to 32.6
Change From Baseline OABq-LF HRQL Total Score 6.0	21.8 units on a scale Interval 16.0 to 27.5	25.9 units on a scale Interval 19.4 to 32.3
Change From Baseline OABq-LF HRQL Total Score 9.0	14.8 units on a scale Interval 9.2 to 20.4	23.9 units on a scale Interval 16.8 to 30.9
Change From Baseline OABq-LF HRQL Total Score 12.0	20.3 units on a scale Interval 14.3 to 26.4	29.1 units on a scale Interval 21.4 to 36.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Satisfaction score ranges from 0 to 100 with higher scores indicating higher satisfaction.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
OAB-SATq-LF Satisfaction Score 3.0	65.7 units on a scale Interval 58.7 to 72.7	60.1 units on a scale Interval 51.9 to 68.3
OAB-SATq-LF Satisfaction Score 6.0	64.5 units on a scale Interval 57.6 to 71.3	60.3 units on a scale Interval 52.5 to 68.2
OAB-SATq-LF Satisfaction Score 9.0	64.4 units on a scale Interval 57.5 to 71.2	57.5 units on a scale Interval 48.8 to 66.2
OAB-SATq-LF Satisfaction Score 12.0	60.4 units on a scale Interval 53.0 to 67.8	56.3 units on a scale Interval 46.8 to 65.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Side Effect score ranges from 0 to 100 with higher scores indicating fewer side effects.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
OAB-SATq-LF Side Effects Score 3.0	91.9 units on a scale Interval 87.5 to 96.4	93.5 units on a scale Interval 89.7 to 97.3
OAB-SATq-LF Side Effects Score 6.0	89 units on a scale Interval 83.5 to 94.5	87.4 units on a scale Interval 81.5 to 93.4
OAB-SATq-LF Side Effects Score 9.0	90.2 units on a scale Interval 84.4 to 95.9	86.3 units on a scale Interval 79.7 to 92.9
OAB-SATq-LF Side Effects Score 12.0	91.8 units on a scale Interval 87.0 to 96.6	88.5 units on a scale Interval 82.2 to 94.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Endorsement score ranges from 0 to 100 with higher scores indicating greater endorsement.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
OAB-SATq-LF Endorsement Score 3.0	74.3 units on a scale Interval 67.8 to 80.9	67.9 units on a scale Interval 59.8 to 76.0
OAB-SATq-LF Endorsement Score 6.0	72 units on a scale Interval 64.4 to 79.6	68.3 units on a scale Interval 60.5 to 76.0
OAB-SATq-LF Endorsement Score 9.0	77.7 units on a scale Interval 70.5 to 84.9	73.6 units on a scale Interval 65.6 to 81.7
OAB-SATq-LF Endorsement Score 12.0	71.7 units on a scale Interval 63.8 to 79.5	68.2 units on a scale Interval 59.0 to 77.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Convenience score ranges from 0 to 100 with higher scores indicating greater convenience.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
OAB-SATq-LF Convenience Score 3.0	64.2 units on a scale Interval 57.6 to 70.7	64.1 units on a scale Interval 56.7 to 71.4
OAB-SATq-LF Convenience Score 6.0	66.5 units on a scale Interval 59.3 to 73.6	66.8 units on a scale Interval 60.0 to 73.5
OAB-SATq-LF Convenience Score 9.0	67.6 units on a scale Interval 62.5 to 72.8	64.7 units on a scale Interval 58.1 to 71.3
OAB-SATq-LF Convenience Score 12.0	65.6 units on a scale Interval 59.7 to 71.4	66.3 units on a scale Interval 58.5 to 74.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The preference score is a binary \[yes/no\] indicator as to whether a subject indicated slight or definite preference for the treatment among women that have had previous treatment for overactive bladder. The outcome is the percentage of participants that prefer the current treatment to previous treatments.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
OAB-SAT-q Preference Indicator 3.0 · Unknown	16 Participants	24 Participants
OAB-SAT-q Preference Indicator 3.0 · No	5 Participants	5 Participants
OAB-SAT-q Preference Indicator 3.0 · Yes	47 Participants	35 Participants
OAB-SAT-q Preference Indicator 6.0 · Unknown	17 Participants	21 Participants
OAB-SAT-q Preference Indicator 6.0 · No	6 Participants	8 Participants
OAB-SAT-q Preference Indicator 6.0 · Yes	41 Participants	36 Participants
OAB-SAT-q Preference Indicator 9.0 · Unknown	17 Participants	15 Participants
OAB-SAT-q Preference Indicator 9.0 · No	5 Participants	5 Participants
OAB-SAT-q Preference Indicator 9.0 · Yes	33 Participants	36 Participants
OAB-SAT-q Preference Indicator 12.0 · Unknown	15 Participants	19 Participants
OAB-SAT-q Preference Indicator 12.0 · No	10 Participants	7 Participants
OAB-SAT-q Preference Indicator 12.0 · Yes	36 Participants	34 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better).

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
PGI-I Score Binary Improvement Indicator 3.0 · No	28 Participants	30 Participants
PGI-I Score Binary Improvement Indicator 3.0 · Yes	40 Participants	34 Participants
PGI-I Score Binary Improvement Indicator 6.0 · No	25 Participants	33 Participants
PGI-I Score Binary Improvement Indicator 6.0 · Yes	39 Participants	32 Participants
PGI-I Score Binary Improvement Indicator 9.0 · No	22 Participants	25 Participants
PGI-I Score Binary Improvement Indicator 9.0 · Yes	34 Participants	31 Participants
PGI-I Score Binary Improvement Indicator 12.0 · No	35 Participants	31 Participants
PGI-I Score Binary Improvement Indicator 12.0 · Yes	26 Participants	29 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3, 6, 9, and 12 Months

The Patient Global Impression of Severity (PGI-S) is a patient-reported measure of perceived severity of condition, as assessed on a scale of 1 (Normal) to 4 (Severe). Included here are participants who reported Normal or Mild severity as indicated by a rating of 1 or 2.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
PGI-S Score Binary Condition Severity Indicator Baseline · No	57 Participants	53 Participants
PGI-S Score Binary Condition Severity Indicator Baseline · Yes	13 Participants	10 Participants
PGI-S Score Binary Condition Severity Indicator 3.0 · No	29 Participants	30 Participants
PGI-S Score Binary Condition Severity Indicator 3.0 · Yes	39 Participants	34 Participants
PGI-S Score Binary Condition Severity Indicator 6.0 · No	29 Participants	29 Participants
PGI-S Score Binary Condition Severity Indicator 6.0 · Yes	35 Participants	36 Participants
PGI-S Score Binary Condition Severity Indicator 9.0 · No	27 Participants	24 Participants
PGI-S Score Binary Condition Severity Indicator 9.0 · Yes	29 Participants	32 Participants
PGI-S Score Binary Condition Severity Indicator 12.0 · No	28 Participants	24 Participants
PGI-S Score Binary Condition Severity Indicator 12.0 · Yes	33 Participants	36 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 Months

Patient GLobal Impression of Symptom Control(PGSC) is a patient-reported measure of perceived adequate symptom control, as assessed on a scale of 1 (disagree strongly) to 5 (agree strongly). Included here are participants who had adequate control as indicated by a rating of 5 (agree strongly) or 4 (agree).

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
PGSC Score Binary Improvement Indicator 3.0 · No	32 Participants	28 Participants
PGSC Score Binary Improvement Indicator 3.0 · Yes	36 Participants	36 Participants
PGSC Score Binary Improvement Indicator 6.0 · No	30 Participants	33 Participants
PGSC Score Binary Improvement Indicator 6.0 · Yes	34 Participants	32 Participants
PGSC Score Binary Improvement Indicator 9.0 · No	28 Participants	27 Participants
PGSC Score Binary Improvement Indicator 9.0 · Yes	28 Participants	29 Participants
PGSC Score Binary Improvement Indicator 12.0 · No	33 Participants	24 Participants
PGSC Score Binary Improvement Indicator 12.0 · Yes	29 Participants	36 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Partner Related (NSA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=33 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=35 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline PISQ-IR NSA-PR Score 3.0	0.3 units on a scale Interval -0.1 to 0.7	0.3 units on a scale Interval 0.1 to 0.5
Change From Baseline PISQ-IR NSA-PR Score 6.0	0 units on a scale Interval -0.4 to 0.4	0.3 units on a scale Interval 0.0 to 0.6
Change From Baseline PISQ-IR NSA-PR Score 9.0	0.1 units on a scale Interval -0.3 to 0.6	0.1 units on a scale Interval -0.3 to 0.5
Change From Baseline PISQ-IR NSA-PR Score 12.0	0.3 units on a scale Interval 0.0 to 0.6	0.1 units on a scale Interval -0.3 to 0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Specific (NSA-CS) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=32 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=34 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline PISQ-IR NSA-CS Score 3.0	-0.2 units on a scale Interval -0.5 to 0.0	-0.1 units on a scale Interval -0.5 to 0.2
Change From Baseline PISQ-IR NSA-CS Score 6.0	-0.2 units on a scale Interval -0.7 to 0.2	0 units on a scale Interval -0.3 to 0.4
Change From Baseline PISQ-IR NSA-CS Score 9.0	-0.2 units on a scale Interval -0.4 to 0.1	-0.1 units on a scale Interval -0.4 to 0.2
Change From Baseline PISQ-IR NSA-CS Score 12.0	0.2 units on a scale Interval -0.1 to 0.6	-0.3 units on a scale Interval -0.7 to 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Global Quality Rating (NSA-GQA) ranges from 1 to 4.5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=32 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=34 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline PISQ-IR NSA-GQA Score 3.0	-0.1 units on a scale Interval -0.5 to 0.2	-0.3 units on a scale Interval -0.6 to 0.1
Change From Baseline PISQ-IR NSA-GQA Score 6.0	-0.3 units on a scale Interval -0.8 to 0.2	-0.3 units on a scale Interval -0.8 to 0.1
Change From Baseline PISQ-IR NSA-GQA Score 9.0	-0.2 units on a scale Interval -0.8 to 0.4	-0.4 units on a scale Interval -0.8 to -0.1
Change From Baseline PISQ-IR NSA-GQA Score 12.0	-0.4 units on a scale Interval -0.9 to 0.1	-0.2 units on a scale Interval -0.7 to 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Impact (NSA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=32 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=35 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline PISQ-IR NSA-CI Score 3.0	-0.3 units on a scale Interval -0.6 to 0.0	-0.4 units on a scale Interval -0.8 to 0.0
Change From Baseline PISQ-IR NSA-CI Score 6.0	-0.3 units on a scale Interval -0.7 to 0.1	-0.3 units on a scale Interval -0.8 to 0.1
Change From Baseline PISQ-IR NSA-CI Score 9.0	-0.3 units on a scale Interval -0.8 to 0.1	-0.2 units on a scale Interval -0.7 to 0.2
Change From Baseline PISQ-IR NSA-CI Score 12.0	-0.2 units on a scale Interval -0.5 to 0.1	-0.4 units on a scale Interval -0.8 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Arousal Orgasm (SA-AO) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=31 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=28 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline PISQ-IR SA-AO Score 12.0	0 units on a scale Interval -0.3 to 0.3	0 units on a scale Interval -0.3 to 0.2
Change From Baseline PISQ-IR SA-AO Score 3.0	0 units on a scale Interval -0.1 to 0.2	-0.1 units on a scale Interval -0.5 to 0.3
Change From Baseline PISQ-IR SA-AO Score 6.0	0 units on a scale Interval -0.2 to 0.2	0.1 units on a scale Interval -0.2 to 0.3
Change From Baseline PISQ-IR SA-AO Score 9.0	-0.1 units on a scale Interval -0.4 to 0.2	0.1 units on a scale Interval -0.2 to 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Partner Related (SA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=28 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=26 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline PISQ-IR SA-PR Score 3.0	0 units on a scale Interval -0.3 to 0.2	0 units on a scale Interval -0.3 to 0.2
Change From Baseline PISQ-IR SA-PR Score 6.0	0 units on a scale Interval -0.2 to 0.3	0.1 units on a scale Interval -0.2 to 0.5
Change From Baseline PISQ-IR SA-PR Score 9.0	-0.1 units on a scale Interval -0.3 to 0.2	-0.3 units on a scale Interval -0.6 to 0.0
Change From Baseline PISQ-IR SA-PR Score 12.0	-0.1 units on a scale Interval -0.5 to 0.2	-0.1 units on a scale Interval -0.4 to 0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Specific (SA-CS) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=30 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=25 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline PISQ-IR SA-CS Score 9.0	0.3 units on a scale Interval -0.1 to 0.6	0.2 units on a scale Interval -0.4 to 0.8
Change From Baseline PISQ-IR SA-CS Score 12.0	0.3 units on a scale Interval -0.1 to 0.6	0.4 units on a scale Interval -0.2 to 1.1
Change From Baseline PISQ-IR SA-CS Score 3.0	0.5 units on a scale Interval 0.2 to 0.7	0.5 units on a scale Interval 0.1 to 0.8
Change From Baseline PISQ-IR SA-CS Score 6.0	0.3 units on a scale Interval 0.0 to 0.6	0.6 units on a scale Interval 0.1 to 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Global Quality Rating (SA-GQR) ranges from 1 to 4.75 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=30 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=28 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline PISQ-IR SA-GQR Score 6.0	0 units on a scale Interval -0.3 to 0.4	0.2 units on a scale Interval -0.2 to 0.5
Change From Baseline PISQ-IR SA-GQR Score 9.0	-0.1 units on a scale Interval -0.6 to 0.3	-0.4 units on a scale Interval -0.9 to 0.1
Change From Baseline PISQ-IR SA-GQR Score 3.0	0 units on a scale Interval -0.4 to 0.3	0.3 units on a scale Interval -0.1 to 0.7
Change From Baseline PISQ-IR SA-GQR Score 12.0	-0.1 units on a scale Interval -0.4 to 0.3	-0.2 units on a scale Interval -0.5 to 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Impact (SA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=31 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=28 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline PISQ-IR SA-CI Score 3.0	0.4 units on a scale Interval 0.1 to 0.7	0.6 units on a scale Interval 0.3 to 1.0
Change From Baseline PISQ-IR SA-CI Score 6.0	0.2 units on a scale Interval -0.1 to 0.5	0.8 units on a scale Interval 0.4 to 1.1
Change From Baseline PISQ-IR SA-CI Score 9.0	0.3 units on a scale Interval 0.0 to 0.6	0.3 units on a scale Interval -0.1 to 0.7
Change From Baseline PISQ-IR SA-CI Score 12.0	0.3 units on a scale Interval -0.1 to 0.6	0.9 units on a scale Interval 0.5 to 1.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Desire (SA-D) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=30 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=28 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline PISQ-IR SA-D Score 3.0	0.1 units on a scale Interval -0.1 to 0.4	0.1 units on a scale Interval -0.2 to 0.3
Change From Baseline PISQ-IR SA-D Score 6.0	0 units on a scale Interval -0.2 to 0.1	-0.1 units on a scale Interval -0.3 to 0.1
Change From Baseline PISQ-IR SA-D Score 9.0	0 units on a scale Interval -0.3 to 0.2	0.1 units on a scale Interval -0.2 to 0.4
Change From Baseline PISQ-IR SA-D Score 12.0	-0.2 units on a scale Interval -0.5 to 0.1	0 units on a scale Interval -0.3 to 0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 9, and 12 months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=31 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=28 Participants Mid-Urethral Sling for treatment of urinary incont
Change From Baseline PISQ-IR SA Average Score 12.0	0 units on a scale Interval -0.2 to 0.2	0.2 units on a scale Interval 0.0 to 0.4
Change From Baseline PISQ-IR SA Average Score 3.0	0.2 units on a scale Interval 0.0 to 0.3	0.2 units on a scale Interval 0.1 to 0.4
Change From Baseline PISQ-IR SA Average Score 6.0	0.1 units on a scale Interval -0.1 to 0.2	0.3 units on a scale Interval 0.1 to 0.5
Change From Baseline PISQ-IR SA Average Score 9.0	0 units on a scale Interval -0.1 to 0.2	0 units on a scale Interval -0.2 to 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for physical function domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
SF-36 Physical Functioning Score 0.5	12.9 units on a scale Interval 6.3 to 19.5	12.2 units on a scale Interval 6.3 to 18.1
SF-36 Physical Functioning Score 3.0	10.9 units on a scale Interval 4.8 to 17.0	13.9 units on a scale Interval 7.1 to 20.6
SF-36 Physical Functioning Score 6.0	10.5 units on a scale Interval 4.6 to 16.3	14 units on a scale Interval 7.1 to 20.9
SF-36 Physical Functioning Score 9.0	8.9 units on a scale Interval 1.8 to 15.9	9.7 units on a scale Interval 3.6 to 15.7
SF-36 Physical Functioning Score 12.0	10 units on a scale Interval 4.1 to 15.9	13.3 units on a scale Interval 6.5 to 20.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for physical role limitations domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
SF-36 Role Physical Score 12.0	8.6 units on a scale Interval -1.2 to 18.4	4.9 units on a scale Interval -7.3 to 17.1
SF-36 Role Physical Score 0.5	14.1 units on a scale Interval 3.1 to 25.2	-1.2 units on a scale Interval -12.7 to 10.3
SF-36 Role Physical Score 3.0	12.5 units on a scale Interval 2.2 to 22.8	11.3 units on a scale Interval 1.6 to 21.1
SF-36 Role Physical Score 6.0	12.3 units on a scale Interval 1.7 to 22.9	12.1 units on a scale Interval 2.0 to 22.2
SF-36 Role Physical Score 9.0	3.6 units on a scale Interval -8.3 to 15.6	7.7 units on a scale Interval -4.3 to 19.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for bodily pain domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
SF-36 Bodily Pain Score 0.5	2.6 units on a scale Interval -3.0 to 8.2	2.4 units on a scale Interval -3.6 to 8.5
SF-36 Bodily Pain Score 3.0	5.1 units on a scale Interval -0.6 to 10.9	0.6 units on a scale Interval -5.4 to 6.5
SF-36 Bodily Pain Score 12.0	-0.8 units on a scale Interval -6.9 to 5.2	6.4 units on a scale Interval 0.1 to 12.7
SF-36 Bodily Pain Score 6.0	-0.4 units on a scale Interval -6.3 to 5.5	0.8 units on a scale Interval -5.1 to 6.6
SF-36 Bodily Pain Score 9.0	-1.6 units on a scale Interval -8.1 to 5.0	4.2 units on a scale Interval -1.8 to 10.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
SF-36 General Health Score 9.0	-1.6 units on a scale Interval -6.0 to 2.7	-2.2 units on a scale Interval -6.5 to 2.2
SF-36 General Health Score 0.5	5.2 units on a scale Interval 1.9 to 8.4	2.5 units on a scale Interval -1.2 to 6.3
SF-36 General Health Score 3.0	2.4 units on a scale Interval -1.3 to 6.0	-1.7 units on a scale Interval -5.8 to 2.5
SF-36 General Health Score 6.0	2.6 units on a scale Interval -1.4 to 6.7	-0.6 units on a scale Interval -4.4 to 3.2
SF-36 General Health Score 12.0	-1.1 units on a scale Interval -5.3 to 3.1	-0.3 units on a scale Interval -4.8 to 4.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for vitality domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
SF-36 Vitality Score 3.0	3.5 units on a scale Interval -1.7 to 8.6	5.3 units on a scale Interval 0.6 to 10.1
SF-36 Vitality Score 0.5	6.1 units on a scale Interval 1.0 to 11.1	6.5 units on a scale Interval 1.8 to 11.3
SF-36 Vitality Score 6.0	4.7 units on a scale Interval -0.1 to 9.5	3.4 units on a scale Interval -1.2 to 8.1
SF-36 Vitality Score 9.0	-0.8 units on a scale Interval -5.8 to 4.2	-1.3 units on a scale Interval -6.5 to 4.0
SF-36 Vitality Score 12.0	2.7 units on a scale Interval -2.3 to 7.7	0.4 units on a scale Interval -5.2 to 6.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for social functioning domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
SF-36 Social Functioning Score 9.0	4.5 units on a scale Interval -1.3 to 10.4	12.3 units on a scale Interval 5.0 to 19.5
SF-36 Social Functioning Score 12.0	6.4 units on a scale Interval -0.4 to 13.1	7.1 units on a scale Interval 0.3 to 13.8
SF-36 Social Functioning Score 0.5	10.9 units on a scale Interval 5.0 to 16.7	9.1 units on a scale Interval 3.2 to 15.0
SF-36 Social Functioning Score 3.0	11 units on a scale Interval 4.9 to 17.2	5.7 units on a scale Interval -1.4 to 12.7
SF-36 Social Functioning Score 6.0	11.5 units on a scale Interval 5.6 to 17.4	6.6 units on a scale Interval 0.1 to 13.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for emotional role limitation domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
SF-36 Emotional Role Limitations Score 12.0	9.8 units on a scale Interval 1.8 to 17.8	13.3 units on a scale Interval 2.0 to 24.7
SF-36 Emotional Role Limitations Score 0.5	16.4 units on a scale Interval 5.8 to 27.0	12.2 units on a scale Interval 0.9 to 23.5
SF-36 Emotional Role Limitations Score 3.0	19.9 units on a scale Interval 9.1 to 30.6	14.6 units on a scale Interval 3.0 to 26.2
SF-36 Emotional Role Limitations Score 6.0	12.7 units on a scale Interval 4.7 to 20.7	12.5 units on a scale Interval 0.9 to 24.1
SF-36 Emotional Role Limitations Score 9.0	13 units on a scale Interval 1.9 to 24.2	7.4 units on a scale Interval -3.3 to 18.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for social functioning domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
SF-36 Mental Health Score 0.5	0.2 units on a scale Interval -3.7 to 4.1	5 units on a scale Interval 1.3 to 8.7
SF-36 Mental Health Score 3.0	0.8 units on a scale Interval -3.1 to 4.7	1.8 units on a scale Interval -3.4 to 7.0
SF-36 Mental Health Score 6.0	-2 units on a scale Interval -6.4 to 2.5	1 units on a scale Interval -3.5 to 5.6
SF-36 Mental Health Score 9.0	-2.4 units on a scale Interval -6.5 to 1.8	0.6 units on a scale Interval -4.2 to 5.5
SF-36 Mental Health Score 12.0	-0.7 units on a scale Interval -4.8 to 3.3	1.3 units on a scale Interval -3.7 to 6.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

SF-36 is a standardized survey evaluating 8 domains of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The physical composite score is a normalized t-score which combines the all 8 domains with a mean of 50 and standard deviation of 10 (higher scores indicate greater physical function). A t-score below 50 is a good all-around cutoff for detecting physical condition (per the Ware manual). The outcome is calculated as the difference in score at 2 weeks and 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
SF-36 Physical Composite Score 6.0	3 T-score Interval 0.7 to 5.3	3.1 T-score Interval 0.7 to 5.4
SF-36 Physical Composite Score 9.0	1.1 T-score Interval -1.6 to 3.8	2.2 T-score Interval -0.5 to 4.9
SF-36 Physical Composite Score 12.0	2 T-score Interval -0.2 to 4.2	2.8 T-score Interval 0.5 to 5.2
SF-36 Physical Composite Score 0.5	3.9 T-score Interval 1.7 to 6.2	1.5 T-score Interval -0.6 to 3.6
SF-36 Physical Composite Score 3.0	3.1 T-score Interval 0.8 to 5.3	2.6 T-score Interval 0.2 to 5.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

SF-36 is a standardized survey evaluating 8 domains of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The mental composite score is a normalized t-score which combines the all 8 domains with a mean of 50 and standard deviation of 10 (higher scores indicate greater mental health). A t-score below 52 is a well-documented cutoff for detecting depression (per the Ware manual). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
SF-36 Mental Composite Score 0.5	2.2 T-score Interval 0.0 to 4.5	3.5 T-score Interval 1.2 to 5.8
SF-36 Mental Composite Score 6.0	1.6 T-score Interval -0.8 to 3.9	1.2 T-score Interval -1.2 to 3.6
SF-36 Mental Composite Score 9.0	0.6 T-score Interval -1.9 to 3.1	1 T-score Interval -1.8 to 3.7
SF-36 Mental Composite Score 12.0	0.9 T-score Interval -1.3 to 3.1	1.2 T-score Interval -1.7 to 4.1
SF-36 Mental Composite Score 3.0	2.7 T-score Interval 0.1 to 5.4	1.9 T-score Interval -0.8 to 4.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3, 6, and 12 Months

Postvoid Residual Volume

Outcome measures

Outcome measures
Measure	Botox A n=71 Participants Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=66 Participants Mid-Urethral Sling for treatment of urinary incont
Postvoid Residual Volume Baseline	20.4 mL Interval 14.6 to 26.3	22.7 mL Interval 15.9 to 29.5
Postvoid Residual Volume 0.5	49.4 mL Interval 33.8 to 65.1	26.5 mL Interval 19.5 to 33.5
Postvoid Residual Volume 3.0	39.4 mL Interval 25.0 to 53.7	27.2 mL Interval 19.2 to 35.3
Postvoid Residual Volume 6.0	31.7 mL Interval 19.2 to 44.2	37.1 mL Interval 23.9 to 50.3

Adverse Events

Botox A

Serious events: 3 serious events

Other events: 40 other events

Deaths: 0 deaths

Mid-Urethral Sling

Serious events: 8 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Botox A n=71 participants at risk Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=69 participants at risk Mid-Urethral Sling for treatment of urinary incont
Cardiac disorders Cardiac failure	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Cardiac disorders Cardiac failure congestive	1.4% 1/71 • Number of events 2 • 12 Months	0.00% 0/69 • 12 Months
Cardiac disorders Myocardial infarction	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Cardiac disorders Ventricular extrasystoles	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Infections and infestations Chronic sinusitis	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Infections and infestations Pyelonephritis	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Metabolism and nutrition disorders Obesity	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Nervous system disorders Ischaemic stroke	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Nervous system disorders Syncope	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Renal and urinary disorders Acute kidney injury	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months

Other adverse events

Other adverse events
Measure	Botox A n=71 participants at risk Up to 2 administrations of Botulinum Toxin A	Mid-Urethral Sling n=69 participants at risk Mid-Urethral Sling for treatment of urinary incont
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/71 • 12 Months	2.9% 2/69 • Number of events 2 • 12 Months
Injury, poisoning and procedural complications Contusion	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Injury, poisoning and procedural complications Fall	1.4% 1/71 • Number of events 1 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 1/71 • Number of events 2 • 12 Months	2.9% 2/69 • Number of events 2 • 12 Months
Injury, poisoning and procedural complications Ligament sprain	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Musculoskeletal and connective tissue disorders Arthritis	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Musculoskeletal and connective tissue disorders Back pain	1.4% 1/71 • Number of events 1 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Flank pain	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Nervous system disorders Dizziness	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Nervous system disorders Migraine	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Psychiatric disorders Anxiety	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Investigations Biopsy breast	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Investigations Blood cholesterol increased	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Investigations Blood triglycerides increased	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Investigations Residual urine volume	4.2% 3/71 • Number of events 3 • 12 Months	0.00% 0/69 • 12 Months
Metabolism and nutrition disorders Diabetes mellitus	1.4% 1/71 • Number of events 1 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Cardiac disorders Atrial fibrillation	1.4% 1/71 • Number of events 2 • 12 Months	0.00% 0/69 • 12 Months
Ear and labyrinth disorders Ear pain	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Gastrointestinal disorders Abdominal pain	1.4% 1/71 • Number of events 1 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Gastrointestinal disorders Constipation	0.00% 0/71 • 12 Months	2.9% 2/69 • Number of events 2 • 12 Months
Gastrointestinal disorders Defaecation urgency	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Gastrointestinal disorders Diarrhoea	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Gastrointestinal disorders Dyschezia	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Gastrointestinal disorders Gastrooesophageal reflux disease	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Gastrointestinal disorders Levator syndrome	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
General disorders Adverse drug reaction	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
General disorders Chest pain	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
General disorders Fatigue	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
General disorders Medical device site erosion	0.00% 0/71 • 12 Months	2.9% 2/69 • Number of events 2 • 12 Months
General disorders Oedema	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
General disorders Oedema peripheral	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
General disorders Suprapubic pain	0.00% 0/71 • 12 Months	2.9% 2/69 • Number of events 2 • 12 Months
Immune system disorders Multiple allergies	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Infections and infestations Cellulitis	0.00% 0/71 • 12 Months	2.9% 2/69 • Number of events 2 • 12 Months
Infections and infestations Coronavirus infection	5.6% 4/71 • Number of events 4 • 12 Months	0.00% 0/69 • 12 Months
Infections and infestations Ear infection	0.00% 0/71 • 12 Months	2.9% 2/69 • Number of events 2 • 12 Months
Infections and infestations Fungal skin infection	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Infections and infestations Gastroenteritis	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Infections and infestations Gonococcal pelvic inflammatory disease	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Infections and infestations Laryngitis	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Infections and infestations Otitis externa fungal	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Infections and infestations Pharyngitis	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Infections and infestations Pyelonephritis	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Infections and infestations Sinusitis	2.8% 2/71 • Number of events 2 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Infections and infestations Skin candida	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Infections and infestations Upper respiratory tract infection	1.4% 1/71 • Number of events 1 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Infections and infestations Urinary tract infection	33.8% 24/71 • Number of events 31 • 12 Months	37.7% 26/69 • Number of events 34 • 12 Months
Psychiatric disorders Depression	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Renal and urinary disorders Dysuria	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Renal and urinary disorders Urinary retention	4.2% 3/71 • Number of events 3 • 12 Months	8.7% 6/69 • Number of events 6 • 12 Months
Reproductive system and breast disorders Atrophic vulvovaginitis	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Reproductive system and breast disorders Dyspareunia	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Reproductive system and breast disorders Pelvic discomfort	0.00% 0/71 • 12 Months	2.9% 2/69 • Number of events 2 • 12 Months
Reproductive system and breast disorders Pelvic pain	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Reproductive system and breast disorders Vaginal prolapse	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Respiratory, thoracic and mediastinal disorders Cough	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Respiratory, thoracic and mediastinal disorders Respiratory symptom	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Skin and subcutaneous tissue disorders Alopecia areata	1.4% 1/71 • Number of events 1 • 12 Months	0.00% 0/69 • 12 Months
Skin and subcutaneous tissue disorders Lichen sclerosus	0.00% 0/71 • 12 Months	2.9% 2/69 • Number of events 2 • 12 Months
Social circumstances Contraindication to vaccination	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Surgical and medical procedures Cataract operation	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 2 • 12 Months
Surgical and medical procedures Eye operation	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Surgical and medical procedures Knee arthroplasty	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Surgical and medical procedures Spinal nerve stimulator removal	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Surgical and medical procedures Tooth extraction	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Surgical and medical procedures Vaginal mesh removal surgery	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Vascular disorders Haemorrhage	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months
Vascular disorders Hypertension	0.00% 0/71 • 12 Months	1.4% 1/69 • Number of events 1 • 12 Months

Additional Information

Marie Gantz

RTI International

Phone: 919-541-5110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place