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Study Title and Description

OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial.



Key Questions Addressed
1 KQ 1: What are the benefits and harms of nonpharmacological treatments of UI in women, and how do they compare with each other? KQ 2: What are the benefits and harms of pharmacological treatments of UI in women, and how do they compare with each other? KQ 3: What are the comparative benefits and harms of nonpharmacological versus pharmacological treatments of UI in women? KQ 4: What are the benefits and harms of combined nonpharmacological and pharmacological treatment of UI in women?
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Primary Publication Information
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TitleData
Title OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial.
Author Amundsen CL., Richter HE., Menefee SA., Komesu YM., Arya LA., Gregory WT., Myers DL., Zyczynski HM., Vasavada S., Nolen TL., Wallace D., Meikle SF.
Country Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina.
Year 2016
Numbers Pubmed ID: 27701661

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: All studies
Arms
Number Title Description Comments
1 OnabotulinumtoxinA
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2 Sacral Neuromodulation
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries USA
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Funding source Explicitly not industry funded
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Inclusion criteria Refractory urgency UI; a minimum of 6 urgency incontinence episodes on a baseline 3-day diary
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Exclusion criteria Relevant neurologic diseases; history of using either of the study interventions; or a postvoid residual of more than 150 mL
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UI type 100
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Persistent symptoms despite at least 1 supervised behavioral or physical therapy intervention and the use of a minimum of 2 anticholinergics (or inability to tolerate or contraindications to the medication)
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Age 63
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mean
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11.6
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nd
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Men included 0
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Special populations
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311
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85.4
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Post-menopause
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Race
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303
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83.2
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38
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10.4
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23
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6.32
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Other
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Notes
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Did participants fail previous treatment? ... Some ... supervised behavioral or physical therapy intervention; a minimum of 2 anticholinergics (or inability to tolerate or contraindications to the medication)
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Study years 2012-2015
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Baseline Characteristics
Question OnabotulinumtoxinA Sacral Neuromodulation Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 192 194 386
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190 174 364
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6 11 17
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Lost to follow up (2), Withdrew consent (1), Withdrawn by investigator (1), Excluded from analysis (2) Lost to follow up (4), Withdrew consent (2), excluded from primary analysis (5)
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Quality of life      Population: All Participants
Time Point Measure OnabotulinumtoxinA Sacral Neuromodulation


0 months

N Analyzed


6 months

N Analyzed
Net P value
Outcome: Urgency Severity      Population: All Participants Between-Arm Comparisons
Time Point Measure OnabotulinumtoxinA Sacral Neuromodulation Comparison Measure OnabotulinumtoxinA vs. Sacral Neuromodulation


0 months

N Analyzed 190 174
n mild 2 1
n moderate 27 25
n severe 155 143
note Mild = slight, Severe = Severe and Very Severe Mild = slight, Severe = Severe and Very Severe


6 months

N Analyzed 190 174 .14
n mild 29 23
n moderate 33 33
n severe 64 68
note Mild = slight, Severe = Severe and Very Severe Mild = slight, Severe = Severe and Very Severe
Outcome: Cure etc.      Population: All Participants
Time Point Measure OnabotulinumtoxinA Sacral Neuromodulation


0 months

N Analyzed 190 174


6 months

N Analyzed 169 189
Counts 142 159
Proportion 84 84
Net P value
Outcome: Other patient-centered outcomes (placeholder)      Population: All Participants Between-Arm Comparisons
Time Point Measure OnabotulinumtoxinA Sacral Neuromodulation Comparison Measure OnabotulinumtoxinA vs. Sacral Neuromodulation


0 months

N Analyzed 190 174


6 months

N Analyzed 190 174 .49
Counts 113 89
Proportion 92 89
Net P value
Outcome: Incontinence count/frequency (urgency)      Population: All Participants Between-Arm Comparisons
Time Point Measure OnabotulinumtoxinA Sacral Neuromodulation Comparison Measure OnabotulinumtoxinA vs. Sacral Neuromodulation


0 months

N Analyzed 190 174


6 months

N Analyzed 127 99 <0.001 (Cured); 0.004 (improved)
note Cured = complete resolution; improved = 75%+ reduction Cured = complete resolution; improved = 75%+ reduction
n cured 26 2
n improved 63 27
Mean Difference (Net) 95% CI low 95% CI high Net P value
Outcome: Incontinence count/frequency (urgency)      Population: All Participants Between-Arm Comparisons
Time Point Measure OnabotulinumtoxinA Sacral Neuromodulation Comparison Measure OnabotulinumtoxinA vs. Sacral Neuromodulation


0 months

N Analyzed 190 174
Mean 5.4 5.2
SD 2.7 2.7


6 months

N Analyzed 190 174 .63
0.13
1.14
0.01
Within-Arm Comparisons
Comparison Measure OnabotulinumtoxinA Sacral Neuromodulation
6 months vs. 0 months Mean Difference -3.89 -3.25
95% CI low -4.26 -3.64
95% CI high -3.52 -2.87
Adjusted For: stratification variables of age and clinical site. stratification variables of age and clinical site.
Mean Difference (Net) 95% CI low 95% CI high Net P value
Outcome: Urgency Severity      Population: All Participants Between-Arm Comparisons
Time Point Measure OnabotulinumtoxinA Sacral Neuromodulation Comparison Measure OnabotulinumtoxinA vs. Sacral Neuromodulation


0 months

N Analyzed 190 174
Mean 74.6 76.1
SD 19.5 16.8


6 months

N Analyzed 190 174 8.1
3.0
13.3
0.002
Mean Difference (Net) 95% CI low 95% CI high Net P value
Outcome: Urgency Severity      Population: All Participants Between-Arm Comparisons
Time Point Measure OnabotulinumtoxinA Sacral Neuromodulation Comparison Measure OnabotulinumtoxinA vs. Sacral Neuromodulation


0 months

N Analyzed 190 174
Mean 60.9 59.2
SD 18.3 16.9


6 months

N Analyzed 190 174 -1.4
-4.4
1.6
0.36
Mean Difference (Net) 95% CI low 95% CI high Net P value
Outcome: Urgency Severity      Population: All Participants Between-Arm Comparisons
Time Point Measure OnabotulinumtoxinA Sacral Neuromodulation Comparison Measure OnabotulinumtoxinA vs. Sacral Neuromodulation


0 months

N Analyzed 190 174
Mean 52.7 25.5
SD 27.6 25.8


6 months

N Analyzed 190 174 -2.0
-5.4
1.4
.25
Mean Difference (Net) 95% CI low 95% CI high Net P value
Outcome: Cure etc.      Population: All Participants Between-Arm Comparisons
Time Point Measure OnabotulinumtoxinA Sacral Neuromodulation Comparison Measure OnabotulinumtoxinA vs. Sacral Neuromodulation


0 months

N Analyzed 190 174
Mean 0.71 0.74
SD 0.3 0.28


6 months

N Analyzed 190 174 -0.005
-0.029
0.020
.72


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment Low RoB
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RCT:.....Blinding of PATIENTS High RoB
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RCT.....Intention-to-treat-analysis Low RoB modified intention-to-treat population for the primary analysis included all eligible participants who provided at least 1 post-baseline bladder diary assessment.
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ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") High RoB
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ALL.....Incomplete results data (attrition bias) Low RoB
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ALL....Group similarity at baseline (selection bias) Low RoB
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ALL.....Compliance with interventions Low RoB
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NRCS.....Patients in different intervention groups selected in an equivalent manner
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NRCS....Baseline differences between groups accounted for (Adjusted analysis)?
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ALL.....Other issues No
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.