Trial · NCT01166438

Anticholinergic vs. Botox Comparison Study

NCT01166438, Phase 3, Completed, NICHD Pelvic Floor Disorders Network; results first posted 2017-12-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Anticholinergic vs. Botox Comparison Study. Trials, record NCT01166438. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01166438

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Anticholinergic vs. Botox Comparison Study
NCT number: NCT01166438
Status: Completed
Phases: Phase 3
Enrollment: 249 participants, actual
Lead sponsor: NICHD Pelvic Floor Disorders Network
Conditions: Urge Urinary Incontinence, Overactive Bladder
Interventions: Botulinum toxin A (Botox A®), Solifenacin 5mg, Solifenacin 10mg, Trospium chloride
First posted: 2010-07-21
Last updated: 2018-05-02
Results first posted: 2017-12-06

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Urge Urinary Incontinence (UUI) Episodes	Baseline through 6 months	Change from baseline in mean number of UUI episodes over 6 month double-blind period.
Secondary	Change From Baseline in Score on OABq-SF	Baseline through 6 months	Values for the Overactive Bladder Questionnaire Short Form (OABq-SF) are changes from baseline in the adjusted mean scores for months 1 to 6. Scores on the OABq-SF range from 0 to 100, with higher scores on the symptom-severity scale indicating greater severity of symptoms and higher scores on the quality-of-life scale indicating better quality of life. Data were available for 123 participants in the Standardized Anticholinergic Regimen group and 119 in the Botox A A group.
Secondary	Efficacy	6 months	Efficacy outcomes assessed reduction and resolution of incontinence, including urgency urinary incontinence (UUI).
Secondary	Change in PFDI-SF and PFIQ-SF Total Scores	Baseline through 6 months	Values for Pelvic Floor Distress Inventory Short Form (PFDI-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFDI-SF range from 0 to 300, with higher scores indicating more symptoms and more bothersome symptoms. Values for the Pelvic Floor Impact Questionnaire Short Form (PFIQ-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFIQ-SF range from 0 to 300, with higher scores indicating a more negative effect on activities, relationships, and feelings.
Secondary	Patient Global Impression of Improvement	3 and 6 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 adequate improvement, defined as a rating of 1 or 2 (much better).

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Urge Urinary Incontinence (UUI) Episodes	Baseline through 6 months		Mean change in UUI episodes from baselin	MEAN
SECONDARY	Change From Baseline in Score on OABq-SF	Baseline through 6 months		Change from baseline in score on OABq-SF	MEAN
SECONDARY	Efficacy	6 months	Efficacy outcomes were assessed in the modified intention-to-treat population, which included all participants who underwent randomization and received a study medication and who had a baseline measure and at least one follow-up measure for the outcome. Proportions were based on data from participants who returned at least four follow-up diaries.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in PFDI-SF and PFIQ-SF Total Scores	Baseline through 6 months	Data were available for 111 participants in the Standardized Anticholinergic Regimen group and 102 in the Botox A group.	Changes in adjusted mean scores	MEAN
SECONDARY	Patient Global Impression of Improvement	3 and 6 months		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Urge Urinary Incontinence (UUI) Episodes	Botox A	1 Month	-3.13	Standard Error 0.2851	Mean change in UUI episodes from baselin
Change in Urge Urinary Incontinence (UUI) Episodes	Standardized Anticholinergic Regimen	1 Month	-3.15	Standard Error 0.2761	Mean change in UUI episodes from baselin
Change in Urge Urinary Incontinence (UUI) Episodes	Botox A	2 Months	-3.32	Standard Error 0.2854	Mean change in UUI episodes from baselin
Change in Urge Urinary Incontinence (UUI) Episodes	Standardized Anticholinergic Regimen	2 Months	-3.25	Standard Error 0.2762	Mean change in UUI episodes from baselin
Change in Urge Urinary Incontinence (UUI) Episodes	Botox A	3 Months	-3.22	Standard Error 0.2854	Mean change in UUI episodes from baselin
Change in Urge Urinary Incontinence (UUI) Episodes	Standardized Anticholinergic Regimen	3 Months	-3.55	Standard Error 0.278	Mean change in UUI episodes from baselin
Change in Urge Urinary Incontinence (UUI) Episodes	Botox A	4 Months	-3.36	Standard Error 0.2857	Mean change in UUI episodes from baselin
Change in Urge Urinary Incontinence (UUI) Episodes	Standardized Anticholinergic Regimen	4 Months	-3.40	Standard Error 0.2766	Mean change in UUI episodes from baselin
Change in Urge Urinary Incontinence (UUI) Episodes	Botox A	5 Months	-3.42	Standard Error 0.2881	Mean change in UUI episodes from baselin
Change in Urge Urinary Incontinence (UUI) Episodes	Standardized Anticholinergic Regimen	5 Months	-3.49	Standard Error 0.2777	Mean change in UUI episodes from baselin

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Double-blind Phase: 1st 6 Months	STARTED	Botox A	122
Double-blind Phase: 1st 6 Months	STARTED	Standardized Anticholinergic Regimen	127
Double-blind Phase: 1st 6 Months	Treated	Botox A	121
Double-blind Phase: 1st 6 Months	Treated	Standardized Anticholinergic Regimen	126
Double-blind Phase: 1st 6 Months	COMPLETED	Botox A	113
Double-blind Phase: 1st 6 Months	COMPLETED	Standardized Anticholinergic Regimen	118
Double-blind Phase: 1st 6 Months	NOT COMPLETED	Botox A	9
Double-blind Phase: 1st 6 Months	NOT COMPLETED	Standardized Anticholinergic Regimen	9
Off Treatment Follow-up Phase	STARTED	Botox A	85
Off Treatment Follow-up Phase	STARTED	Standardized Anticholinergic Regimen	89

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events72

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
other	Constipation	Gastrointestinal disorders	Botox A	31	121
other	Constipation	Gastrointestinal disorders	Standardized Anticholinergic Regimen	37	126
other	Diarrhea	Gastrointestinal disorders	Botox A	21	121
other	Diarrhea	Gastrointestinal disorders	Standardized Anticholinergic Regimen	15	126
other	Dry mouth	Gastrointestinal disorders	Botox A	44	121
other	Dry mouth	Gastrointestinal disorders	Standardized Anticholinergic Regimen	64	126
other	Nausea	Gastrointestinal disorders	Botox A	6	121
other	Nausea	Gastrointestinal disorders	Standardized Anticholinergic Regimen	5	126
other	Any Gastrointestinal Disorders	Gastrointestinal disorders	Botox A	63	121
other	Any Gastrointestinal Disorders	Gastrointestinal disorders	Standardized Anticholinergic Regimen	74	126

1 to 10 of 72Source ClinicalTrials.gov

See all 72 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Botox A
Total, all-cause mortality	Standardized Anticholinergic Regimen
Total, other adverse events	Botox A	96	121
Total, other adverse events	Standardized Anticholinergic Regimen	97	126
Total, serious adverse events	Botox A	5	121
Total, serious adverse events	Standardized Anticholinergic Regimen	7	126

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22008247	DERIVED	PubMed
23036134	DERIVED	PubMed
26516810	DERIVED	PubMed
27564385	DERIVED	PubMed
33620895	DERIVED	PubMed
38651909	DERIVED	PubMed

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
U10HD041250	Clinical and Translational Resaerch in the Pelvic Floor Disorders Network	BRUBAKER, LINDA	LOYOLA UNIVERSITY CHICAGO	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2001 to 2015	NIH RePORTER
U10HD041261	Perioperative Pelvic Floor Rehab: A Rrandomized Trial	RICHTER, HOLLY E	UNIVERSITY OF ALABAMA AT BIRMINGHAM	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2001 to 2015	NIH RePORTER
U10HD041267	Pelvic Floor Disorders Network - Duke University Clinical Site	VISCO, ANTHONY G	DUKE UNIVERSITY	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2001 to 2015	NIH RePORTER
U10HD054136	Pelvic Floor Disorders Network Clinical Sites	NYGAARD, INGRID E	UNIVERSITY OF UTAH	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2006 to 2015	NIH RePORTER
U10HD054214	Pelvic Floor Disorders Network	LUKACZ, EMILY S.	UNIVERSITY OF CALIFORNIA, SAN DIEGO	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2006 to 2015	NIH RePORTER
U10HD054215	Cleveland Clinic Clinical Site	BARBER, MATTHEW D	CLEVELAND CLINIC LERNER COM-CWRU	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2006 to 2015	NIH RePORTER
U10HD054241	NICHD Pelvic Floor Disorders Network Clinical Sites (U10)	SCHAFFER, JOSEPH I	UT SOUTHWESTERN MEDICAL CENTER	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2006 to 2015	NIH RePORTER
U01HD041249	Pelvic floor Disorders Network-Data Coordinating Center	WEI, JOHN T	UNIVERSITY OF MICHIGAN AT ANN ARBOR	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2001 to 2010	NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Botox A vs Standardized Anticholinergic Regimen: serious adverse events

Source 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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Read this trial from software.

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