Trial · NCT04171531
Sling vs Botox for Mixed Incontinence
NCT04171531, Phase 3, Completed, NICHD Pelvic Floor Disorders Network; results first posted 2025-03-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sling vs Botox for Mixed Incontinence. Trials, record NCT04171531. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04171531
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sling vs Botox for Mixed Incontinence
- NCT number
- NCT04171531
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 150 participants, actual
- Lead sponsor
- NICHD Pelvic Floor Disorders Network
- Conditions
- Urinary Incontinence, Stress, Urinary Incontinence, Urge
- Interventions
- Botox® injection, Mid-urethral sling
- First posted
- 2019-11-21
- Last updated
- 2025-06-03
- Results first posted
- 2025-03-20
Source ClinicalTrials.gov
Registered outcomes55
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | UDI-LF Total Score Change From Baseline | 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. |
| Secondary | UDI-LF Stress Score Change From Baseline | 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. |
| Secondary | UDI-LF Irritative Score Change From Baseline | 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. |
| Other | UDI-LF Obstructive Score Change From Baseline | 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. |
| Other | Average Daily Frequency of Combined Mixed Stress/Urge and Non-categorized Incontinence Epsiodes Change From Baseline | 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. |
| Other | Average Daily Frequency of All Incontinence Epsiodes Change From Baseline | 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. |
| Other | Average Daily Frequency of Diurnal Voids Change From Baseline | 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. |
| Other | Average Daily Frequency of Nocturnal Voids Change From Baseline | 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. |
| Other | Average Daily Frequency of All Voids Change From Baseline | 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. |
| Other | Normalization of Voiding Frequency | 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 |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 registered outcomesOutcomes55
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | UDI-LF Total Score Change From Baseline | 3, 6, 9, and 12 Months | 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. | units on a scale | MEAN |
| SECONDARY | UDI-LF Stress Score Change From Baseline | 3, 6, 9, and 12 Months | 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. | units on a scale | MEAN |
| SECONDARY | UDI-LF Irritative Score Change From Baseline | 3, 6, 9, and 12 Months | 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. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | UDI-LF Obstructive Score Change From Baseline | 3, 6, 9, and 12 Months | 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. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Average Daily Frequency of Combined Mixed Stress/Urge and Non-categorized Incontinence Epsiodes Change From Baseline | 3, 6, and 12 Months | 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. | incontinence episodes/day | MEAN |
| OTHER_PRE_SPECIFIED | Average Daily Frequency of All Incontinence Epsiodes Change From Baseline | 3, 6, and 12 Months | 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. | incontinence episodes/day | MEAN |
| OTHER_PRE_SPECIFIED | Average Daily Frequency of Diurnal Voids Change From Baseline | 3, 6, and 12 Months | 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. | diurnal voids/day | MEAN |
| OTHER_PRE_SPECIFIED | Average Daily Frequency of Nocturnal Voids Change From Baseline | 3, 6, and 12 Months | 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. | nocturnal voids/day | MEAN |
| OTHER_PRE_SPECIFIED | Average Daily Frequency of All Voids Change From Baseline | 3, 6, and 12 Months | 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. | voids/day | MEAN |
| OTHER_PRE_SPECIFIED | Normalization of Voiding Frequency | 3, 6, and 12 Months | 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. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 outcomesResults by group510
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| UDI-LF Total Score Change From Baseline | Botox A | 3.0 | -82.2 | 95% Confidence Interval -100 to -64.4 | units on a scale |
| UDI-LF Total Score Change From Baseline | Mid-Urethral Sling | 3.0 | -84.6 | 95% Confidence Interval -101 to -68.3 | units on a scale |
| UDI-LF Total Score Change From Baseline | Botox A | 6.0 | -74.9 | 95% Confidence Interval -93.6 to -56.1 | units on a scale |
| UDI-LF Total Score Change From Baseline | Mid-Urethral Sling | 6.0 | -89.1 | 95% Confidence Interval -104.7 to -73.5 | units on a scale |
| UDI-LF Total Score Change From Baseline | Botox A | 9.0 | -63.1 | 95% Confidence Interval -81.8 to -44.5 | units on a scale |
| UDI-LF Total Score Change From Baseline | Mid-Urethral Sling | 9.0 | -85.6 | 95% Confidence Interval -102.7 to -68.6 | units on a scale |
| UDI-LF Total Score Change From Baseline | Botox A | 12.0 | -67.7 | 95% Confidence Interval -85.7 to -49.8 | units on a scale |
| UDI-LF Total Score Change From Baseline | Mid-Urethral Sling | 12.0 | -89.2 | 95% Confidence Interval -107.5 to -70.9 | units on a scale |
| UDI-LF Stress Score Change From Baseline | Botox A | 3.0 | -27.9 | 95% Confidence Interval -37.7 to -18.1 | units on a scale |
| UDI-LF Stress Score Change From Baseline | Mid-Urethral Sling | 3.0 | -46.4 | 95% Confidence Interval -55.4 to -37.3 | units on a scale |
1 to 10 of 510Source ClinicalTrials.gov
See all 510 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Botox A | 72 | |
| Overall Study | STARTED | Mid-Urethral Sling | 78 | |
| Overall Study | Received Treatment | Botox A | 71 | |
| Overall Study | Received Treatment | Mid-Urethral Sling | 69 | |
| Overall Study | Provided Follow-up Data | Botox A | 71 | |
| Overall Study | Provided Follow-up Data | Mid-Urethral Sling | 66 | |
| Overall Study | COMPLETED | Botox A | 66 | |
| Overall Study | COMPLETED | Mid-Urethral Sling | 63 | |
| Overall Study | NOT COMPLETED | Botox A | 6 | |
| Overall Study | NOT COMPLETED | Mid-Urethral Sling | 15 |
Source ClinicalTrials.gov
Adverse events178
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrial fibrillation | Cardiac disorders | Botox A | 1 | 71 | 2 |
| other | Atrial fibrillation | Cardiac disorders | Mid-Urethral Sling | 0 | 69 | 0 |
| other | Ear pain | Ear and labyrinth disorders | Botox A | 0 | 71 | 0 |
| other | Ear pain | Ear and labyrinth disorders | Mid-Urethral Sling | 1 | 69 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Botox A | 1 | 71 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Mid-Urethral Sling | 1 | 69 | 1 |
| other | Constipation | Gastrointestinal disorders | Botox A | 0 | 71 | 0 |
| other | Constipation | Gastrointestinal disorders | Mid-Urethral Sling | 2 | 69 | 2 |
| other | Defaecation urgency | Gastrointestinal disorders | Botox A | 1 | 71 | 1 |
| other | Defaecation urgency | Gastrointestinal disorders | Mid-Urethral Sling | 0 | 69 | 0 |
1 to 10 of 178Source ClinicalTrials.gov
See all 178 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Botox A | 0 | 71 |
| Total, all-cause mortality | Mid-Urethral Sling | 0 | 69 |
| Total, other adverse events | Botox A | 40 | 71 |
| Total, other adverse events | Mid-Urethral Sling | 41 | 69 |
| Total, serious adverse events | Botox A | 3 | 71 |
| Total, serious adverse events | Mid-Urethral Sling | 8 | 69 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants8
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U24HD069031 | Pelvic Floor Disorders Network Data Coordinating Center | GANTZ, MARIE G | RESEARCH TRIANGLE INSTITUTE | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD041267 | Duke University Medical Center (DUMC) Pelvic Floor Disorders Network (PFDN) Clinical Site | SIDDIQUI, NAZEMA Y | DUKE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD054214 | Pelvic Floor Disorders Network Clinical Site Application: The San Diego Pelvic Floor Consortium | LUKACZ, EMILY S.; MENEFEE, SHAWN A | UNIVERSITY OF CALIFORNIA, SAN DIEGO | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD054241 | Pelvic Floor Disorders Network 2021 | RAHN, DAVID DWIGHT | UT SOUTHWESTERN MEDICAL CENTER | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD069010 | Pelvic Floor Disorders Network | HARVIE, HEIDI S | UNIVERSITY OF PENNSYLVANIA | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD069013 | Brown/WIH Pelvic Floor Disorders Network Site | SUNG, VIVIAN W | WOMEN AND INFANTS HOSPITAL-RHODE ISLAND | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD041261 | University of Alabama at Birmingham: Pelvic Floor Disorders Network | RICHTER, HOLLY E | UNIVERSITY OF ALABAMA AT BIRMINGHAM | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2021 | NIH RePORTER |
| UG1HD069006 | Pittsburgh Pelvic Floor Research Program | ZYCZYNSKI, HALINA M | MAGEE-WOMEN'S RES INST AND FOUNDATION | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2021 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Botox A vs Mid-Urethral Sling: deaths from any cause | Trial comparisons |
| Botox A vs Mid-Urethral Sling: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04171531
GET https://conductscience.org/api/trials/v1/NCT04171531/registered?page=2