21 and older, female only, with Urinary Incontinence, Stress or Urinary Incontinence, Urge. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
UDI-LF Total Score Change From BaselinePrimary· 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 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.
3.0
Group
Value
95% CI
Botox A
-82.2
-100 – -64.4
Mid-Urethral Sling
-84.6
-101 – -68.3
6.0
Group
Value
95% CI
Botox A
-74.9
-93.6 – -56.1
Mid-Urethral Sling
-89.1
-104.7 – -73.5
9.0
Group
Value
95% CI
Botox A
-63.1
-81.8 – -44.5
Mid-Urethral Sling
-85.6
-102.7 – -68.6
12.0
Group
Value
95% CI
Botox A
-67.7
-85.7 – -49.8
Mid-Urethral Sling
-89.2
-107.5 – -70.9
UDI-LF Stress Score Change From BaselineSecondary· 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.
3.0
Group
Value
95% CI
Botox A
-27.9
-37.7 – -18.1
Mid-Urethral Sling
-46.4
-55.4 – -37.3
6.0
Group
Value
95% CI
Botox A
-30.2
-39.6 – -20.9
Mid-Urethral Sling
-45.1
-53.6 – -36.7
9.0
Group
Value
95% CI
Botox A
-20.2
-30.1 – -10.4
Mid-Urethral Sling
-42.3
-53.1 – -31.4
12.0
Group
Value
95% CI
Botox A
-24.3
-34.6 – -14.1
Mid-Urethral Sling
-44.4
-53.8 – -35.1
UDI-LF Irritative Score Change From BaselineSecondary· 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.
3.0
Group
Value
95% CI
Botox A
-40.8
-47.3 – -34.2
Mid-Urethral Sling
-28.1
-35.6 – -20.6
6.0
Group
Value
95% CI
Botox A
-35.8
-43.3 – -28.3
Mid-Urethral Sling
-30.6
-37.4 – -23.8
9.0
Group
Value
95% CI
Botox A
-32.7
-40.5 – -25
Mid-Urethral Sling
-30.8
-38.8 – -22.7
12.0
Group
Value
95% CI
Botox A
-31.6
-39 – -24.2
Mid-Urethral Sling
-33
-41.4 – -24.6
UDI-LF Obstructive Score Change From BaselineSecondary· 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.
3.0
Group
Value
95% CI
Botox A
-13.5
-18.8 – -8.1
Mid-Urethral Sling
-10.1
-14.6 – -5.7
6.0
Group
Value
95% CI
Botox A
-8.9
-13.8 – -4
Mid-Urethral Sling
-13.4
-17.5 – -9.3
9.0
Group
Value
95% CI
Botox A
-10.2
-15.7 – -4.7
Mid-Urethral Sling
-12.6
-17 – -8.2
12.0
Group
Value
95% CI
Botox A
-11.8
-16.4 – -7.2
Mid-Urethral Sling
-11.7
-16.5 – -6.9
Average Daily Frequency of Combined Mixed Stress/Urge and Non-categorized Incontinence Epsiodes Change From BaselineSecondary· 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.
3.0
Group
Value
95% CI
Botox A
-0.4
-0.90 – 0.00
Mid-Urethral Sling
-0.4
-0.90 – 0.10
6.0
Group
Value
95% CI
Botox A
-0.2
-0.50 – 0.10
Mid-Urethral Sling
-0.7
-1.10 – -0.30
12.0
Group
Value
95% CI
Botox A
-0.2
-0.60 – 0.20
Mid-Urethral Sling
-0.7
-1.30 – -0.20
Average Daily Frequency of All Incontinence Epsiodes Change From BaselineSecondary· 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.
3.0
Group
Value
95% CI
Botox A
-4
-4.90 – -3.20
Mid-Urethral Sling
-3.9
-5.00 – -2.80
6.0
Group
Value
95% CI
Botox A
-3.2
-3.90 – -2.40
Mid-Urethral Sling
-4.1
-5.20 – -3.10
12.0
Group
Value
95% CI
Botox A
-3.6
-4.70 – -2.60
Mid-Urethral Sling
-4.5
-5.80 – -3.20
Average Daily Frequency of Diurnal Voids Change From BaselineSecondary· 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.
3.0
Group
Value
95% CI
Botox A
-1.2
-1.70 – -0.70
Mid-Urethral Sling
0
-0.60 – 0.60
6.0
Group
Value
95% CI
Botox A
-0.8
-1.30 – -0.20
Mid-Urethral Sling
-0.2
-0.90 – 0.60
12.0
Group
Value
95% CI
Botox A
-0.8
-1.50 – -0.20
Mid-Urethral Sling
-0.3
-1.00 – 0.40
Average Daily Frequency of Nocturnal Voids Change From BaselineSecondary· 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.
3.0
Group
Value
95% CI
Botox A
-0.5
-0.70 – -0.20
Mid-Urethral Sling
-0.5
-0.80 – -0.10
6.0
Group
Value
95% CI
Botox A
-0.3
-0.60 – -0.10
Mid-Urethral Sling
-0.2
-0.50 – 0.20
12.0
Group
Value
95% CI
Botox A
-0.4
-0.70 – -0.10
Mid-Urethral Sling
-0.4
-0.90 – 0.00
Average Daily Frequency of All Voids Change From BaselineSecondary· 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.
3.0
Group
Value
95% CI
Botox A
-1.6
-2.20 – -1.00
Mid-Urethral Sling
-0.4
-1.10 – 0.20
6.0
Group
Value
95% CI
Botox A
-1.1
-1.70 – -0.50
Mid-Urethral Sling
-0.4
-1.10 – 0.40
12.0
Group
Value
95% CI
Botox A
-1.2
-2.00 – -0.50
Mid-Urethral Sling
-0.7
-1.60 – 0.10
Normalization of Voiding FrequencySecondary· 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
3.0
Group
Value
95% CI
Botox A
17
Mid-Urethral Sling
24
Botox A
23
Mid-Urethral Sling
13
6.0
Group
Value
95% CI
Botox A
17
Mid-Urethral Sling
25
Botox A
18
Mid-Urethral Sling
10
12.0
Group
Value
95% CI
Botox A
13
Mid-Urethral Sling
21
Botox A
24
Mid-Urethral Sling
12
Improvement of 50% or More in Voiding Frequency Post BaselineSecondary· 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
3.0
Group
Value
95% CI
Botox A
60
Mid-Urethral Sling
61
Botox A
1
Mid-Urethral Sling
0
6.0
Group
Value
95% CI
Botox A
53
Mid-Urethral Sling
59
Botox A
0
Mid-Urethral Sling
1
12.0
Group
Value
95% CI
Botox A
50
Mid-Urethral Sling
54
Botox A
3
Mid-Urethral Sling
2
Worsening Voiding Frequency Post BaselineSecondary· 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
3.0
Group
Value
95% CI
Botox A
49
Mid-Urethral Sling
39
Botox A
12
Mid-Urethral Sling
22
6.0
Group
Value
95% CI
Botox A
36
Mid-Urethral Sling
32
Botox A
17
Mid-Urethral Sling
28
12.0
Group
Value
95% CI
Botox A
37
Mid-Urethral Sling
34
Botox A
16
Mid-Urethral Sling
22
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 Months.
Reporting threshold: 0.00%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03616067 — Evaluation of the Efficacy of the Injection of Botulinum Toxin A vs Scopolamine Patches in the Treatment of Drooling in
· Phase 3
· terminated
Other recruiting trials for Urinary Incontinence, Stress
Currently open trials in the same condition.
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· recruiting
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Other NICHD Pelvic Floor Disorders Network trials
Trials by the same sponsor.
NCT07218016 — The AccelERate Trial
· NA
· recruiting
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· NA
· recruiting
NCT06480227 — Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
· NA
· recruiting
NCT03278613 — Neuromodulation for Accidental Bowel Leakage
· NA
· completed
NCT02676973 — Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
· NA
· active not recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NICHD Pelvic Floor Disorders Network
Last refreshed: 3 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04171531.