Trial · NCT00583219

Botulin-A Toxin Instillations and Overactive Bladder

NCT00583219, Phase 1, Phase 2, Completed, Mayo Clinic; results first posted 2014-04-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Botulin-A Toxin Instillations and Overactive Bladder. Trials, record NCT00583219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00583219

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Trial

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

Title: Botulin-A Toxin Instillations and Overactive Bladder
NCT number: NCT00583219
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 25 participants, actual
Lead sponsor: Mayo Clinic
Conditions: Overactive Bladder, Detrusor Instability, Detrusor Hyperreflexia
Interventions: Botulinum-A toxin, Dimethyl sulfoxide (DMSO)
First posted: 2007-12-31
Last updated: 2014-04-21
Results first posted: 2014-04-21

Source ClinicalTrials.gov

Registered outcomes14

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

List	Outcome	Time frame	Description
Primary	Median Number of Incontinent Episodes During 24 Hours	baseline, 1 month, 3 months	The study coordinator instructed the subject to keep record of any incontinence episodes during the 24-hour period prior to their baseline and follow-up visits.
Secondary	Median 24 Hour Pad Weight	baseline, 1 month, 3 months	Prior to baseline and follow-up visits, the study coordinator weighed standard pads provided to the subject for the study time period. The study coordinator instructed the subject to bring in any pads used during the 24-hour period prior to baseline and follow up visits. The study coordinator recorded the 24-hour pad weights into the study dataset.
Secondary	Blaivas-Groutz Anti-Incontinence Score at Baseline	baseline	The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. This score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).
Secondary	Blaivas-Groutz Anti-Incontinence Score at 1 Month	1 month after treatment	The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. This score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).
Secondary	Blaivas-Groutz Anti-Incontinence Score at 3 Months	3 months after treatment	The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. This score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).
Secondary	Mean Number of Pads Per Day	baseline, 1 month, 3 months
Secondary	Postvoid Residual	baseline, 1 month, 3 months
Secondary	Urine Culture	baseline, 1 month, 3 months
Secondary	Urinary Urgency at Baseline	baseline	Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of 'urgency' at each void. The scale employs the following wording: "Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE - no urgency, 1: MILD - awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE - enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE - extreme urgency discomfort that abruptly stops all activity or tasks."
Secondary	Urinary Urgency at 1 Month	1 month after treatment	Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of 'urgency' at each void. The scale employs the following wording: "Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE - no urgency, 1: MILD - awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE - enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE - extreme urgency discomfort that abruptly stops all activity or tasks."

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Median Number of Incontinent Episodes During 24 Hours	baseline, 1 month, 3 months	number of incontinent episodes	MEDIAN
SECONDARY	Median 24 Hour Pad Weight	baseline, 1 month, 3 months	g	MEDIAN
SECONDARY	Blaivas-Groutz Anti-Incontinence Score at Baseline	baseline	participants (per category)	NUMBER
SECONDARY	Blaivas-Groutz Anti-Incontinence Score at 1 Month	1 month after treatment	participants (per category)	NUMBER
SECONDARY	Blaivas-Groutz Anti-Incontinence Score at 3 Months	3 months after treatment	participants (per category)	NUMBER
SECONDARY	Mean Number of Pads Per Day	baseline, 1 month, 3 months	pads per day	MEAN
SECONDARY	Postvoid Residual	baseline, 1 month, 3 months	mL	MEDIAN
SECONDARY	Urine Culture	baseline, 1 month, 3 months	participants	NUMBER
SECONDARY	Urinary Urgency at Baseline	baseline	participants (per category)	NUMBER
SECONDARY	Urinary Urgency at 1 Month	1 month after treatment	participants (per category)	NUMBER

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group51

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

Outcome	Group	Category	Value	Spread	Units
Median Number of Incontinent Episodes During 24 Hours	Botox/DMSO Solution	Baseline	4	Inter-Quartile Range 2 to 9	number of incontinent episodes
Median Number of Incontinent Episodes During 24 Hours	Botox/DMSO Solution	1 month	2	Inter-Quartile Range 0 to 5	number of incontinent episodes
Median Number of Incontinent Episodes During 24 Hours	Botox/DMSO Solution	3 months	4	Inter-Quartile Range 2 to 6	number of incontinent episodes
Median 24 Hour Pad Weight	Botox/DMSO Solution	Baseline	135	Inter-Quartile Range 6 to 259	g
Median 24 Hour Pad Weight	Botox/DMSO Solution	1 month	46	Inter-Quartile Range 9 to 183	g
Median 24 Hour Pad Weight	Botox/DMSO Solution	3 months	55	Inter-Quartile Range 11 to 318	g
Blaivas-Groutz Anti-Incontinence Score at Baseline	Botox/DMSO Solution	None	0		participants (per category)
Blaivas-Groutz Anti-Incontinence Score at Baseline	Botox/DMSO Solution	Mild	4		participants (per category)
Blaivas-Groutz Anti-Incontinence Score at Baseline	Botox/DMSO Solution	Moderate	1		participants (per category)
Blaivas-Groutz Anti-Incontinence Score at Baseline	Botox/DMSO Solution	Severe	16		participants (per category)

1 to 10 of 51Source ClinicalTrials.gov

See all 51 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Phase 1	STARTED	Botox/DMSO Solution	9
Phase 1	COMPLETED	Botox/DMSO Solution	9
Phase 1	NOT COMPLETED	Botox/DMSO Solution	0
Phase 2	STARTED	Botox/DMSO Solution	22
Phase 2	COMPLETED	Botox/DMSO Solution	21
Phase 2	NOT COMPLETED	Botox/DMSO Solution	1

Source ClinicalTrials.gov

Adverse events13

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	Pelvic soreness in first 24 hours	Renal and urinary disorders	Botox/DMSO Solution	1	25	1
other	Positional light-headedness in first 24 hours	General disorders	Botox/DMSO Solution	1	25	1
other	Anxiety in first 24 hours	Psychiatric disorders	Botox/DMSO Solution	1	25	1
other	Bladder spasms in first 24 hours	Renal and urinary disorders	Botox/DMSO Solution	2	25	2
other	Urethral discomfort in first 24 hours	Renal and urinary disorders	Botox/DMSO Solution	2	25	2
other	Dysuria in first 24 hours	Renal and urinary disorders	Botox/DMSO Solution	2	25	2
other	Urinary tract infection after 24 hours	Renal and urinary disorders	Botox/DMSO Solution	3	25	3
other	Perineal rash 7 days after injection	Reproductive system and breast disorders	Botox/DMSO Solution	1	25	1
other	Throbbing with urination 7 days after injection	Renal and urinary disorders	Botox/DMSO Solution	1	25	1
other	Dysuria after 24 hours	Renal and urinary disorders	Botox/DMSO Solution	4	25	4

1 to 10 of 13Source ClinicalTrials.gov

See all 13 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Botox/DMSO Solution
Total, other adverse events	Botox/DMSO Solution	18	25
Total, serious adverse events	Botox/DMSO Solution	0	25

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
19648387	RESULT

Source PubMed

Grants0

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.

None in this release.

Trial comparisons0

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

None in this release.

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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