Trial · NCT00667095
Over Active Bladder Instillation Study - Botox
NCT00667095, Phase 3, Terminated, Mayo Clinic; results first posted 2014-07-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Over Active Bladder Instillation Study - Botox. Trials, record NCT00667095. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00667095
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Over Active Bladder Instillation Study - Botox
- NCT number
- NCT00667095
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 25 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Overactive Bladder, Urinary Urge Incontinence, Urinary Incontinence, Detrusor Hyperreflexia, Urge Incontinence
- Interventions
- Botox Instillation, DMSO Instillation
- First posted
- 2008-04-25
- Last updated
- 2014-07-11
- Results first posted
- 2014-07-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Incontinence Quality of Life (I-QoL) Score | Baseline, 1 month, 3 months | The I-QoL measures the effect of urinary incontinence on quality of life. It is divided into 3 subscales: 1) avoidance and limiting behavior, 2) psychosocial impact, and 3) social embarrassment. The I-QOL is comprised of 22 items, each with the response scale from '1= Extremely' to '5= Not at all'. A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores are then transformed to a 'Scale score' ranging from 0-100 points for ease of interpretation: Scale score = (sum of the items - lowest possible score)/possible raw score range X 100. Higher scores indicate less impact of incontinence on quality of life. |
| Secondary | Change in Incontinence Impact Questionnaire Short Form (IIQ-7) | baseline, 1 month, 3 months | The IIQ-7 measures the effect of urinary incontinence on quality of life. It is comprised of 7 items, each with the response scale from "0=Not at all" to "3=Greatly." The scores can range from 0 to 21; a low score indicates less impact of incontinence on quality of life. |
| Secondary | Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF) | baseline, 1 month, 3 months | The ICIQ-SF provides a brief and robust measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment. The questionnaire has 4 items and the score can range from 0 to 21, with greater values indicating increased severity of symptoms and lower quality of life. |
| Secondary | Change in Urogenital Distress Inventory (UDI-6) | baseline, 1 month, 3 months | The UDI-6 measures the effect of urinary incontinence on quality of life. It consists of 6 items, each with the response scale from "0=Not at all" to "3=Greatly." The scores can range from 0 to 18; a low score indicates less impact of incontinence on quality of life. |
| Secondary | Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 3 Months | baseline, 1 month, 3 months | 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 | Number of Participants With a Decrease in Urinary Urgency at 1 Month and 3 Months | Baseline, 1 month, 3 months | 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." |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Incontinence Quality of Life (I-QoL) Score | Baseline, 1 month, 3 months | Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the Dimethyl Sulfoxide (DMSO) instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer). | units on a scale | MEAN |
| SECONDARY | Change in Incontinence Impact Questionnaire Short Form (IIQ-7) | baseline, 1 month, 3 months | Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the Dimethyl Sulfoxide (DSMO) instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer). | units on a scale | MEAN |
| SECONDARY | Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF) | baseline, 1 month, 3 months | Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer). | units on a scale | MEAN |
| SECONDARY | Change in Urogenital Distress Inventory (UDI-6) | baseline, 1 month, 3 months | Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer). | units on a scale | MEAN |
| SECONDARY | Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 3 Months | baseline, 1 month, 3 months | Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer). | participants | NUMBER |
| SECONDARY | Number of Participants With a Decrease in Urinary Urgency at 1 Month and 3 Months | Baseline, 1 month, 3 months | Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Incontinence Quality of Life (I-QoL) Score | Botox and DMSO Instillation | Change from baseline to 1 month | 9.6 | Standard Deviation 13.3 | units on a scale |
| Change in Incontinence Quality of Life (I-QoL) Score | DMSO Instillation | Change from baseline to 1 month | -3.9 | Standard Deviation 11.6 | units on a scale |
| Change in Incontinence Quality of Life (I-QoL) Score | Botox and DMSO Instillation | Change from baseline to 3 months (n=11, 9) | 8.6 | Standard Deviation 14.4 | units on a scale |
| Change in Incontinence Quality of Life (I-QoL) Score | DMSO Instillation | Change from baseline to 3 months (n=11, 9) | -4.0 | Standard Deviation 9.3 | units on a scale |
| Change in Incontinence Impact Questionnaire Short Form (IIQ-7) | Botox and DMSO Instillation | Change from baseline to 1 month | -2.5 | Standard Deviation 4.0 | units on a scale |
| Change in Incontinence Impact Questionnaire Short Form (IIQ-7) | DMSO Instillation | Change from baseline to 1 month | 2.0 | Standard Deviation 5.9 | units on a scale |
| Change in Incontinence Impact Questionnaire Short Form (IIQ-7) | Botox and DMSO Instillation | Change from baseline to 3 months (n=11, 9) | -1.8 | Standard Deviation 4.2 | units on a scale |
| Change in Incontinence Impact Questionnaire Short Form (IIQ-7) | DMSO Instillation | Change from baseline to 3 months (n=11, 9) | 1.1 | Standard Deviation 3.8 | units on a scale |
| Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF) | Botox and DMSO Instillation | Change from baseline to 1 month | -2.4 | Standard Deviation 5.8 | units on a scale |
| Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF) | DMSO Instillation | Change from baseline to 1 month | -0.5 | Standard Deviation 4.4 | units on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Botox and DMSO Instillation | 11 | |
| Overall Study | STARTED | DMSO Instillation | 10 | |
| Overall Study | COMPLETED | Botox and DMSO Instillation | 11 | |
| Overall Study | COMPLETED | DMSO Instillation | 9 | |
| Overall Study | NOT COMPLETED | Botox and DMSO Instillation | 0 | |
| Overall Study | NOT COMPLETED | DMSO Instillation | 1 |
Source ClinicalTrials.gov
Adverse events22
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 | Urinary Tract Infection | Infections and infestations | Botox and DMSO Instillation | 3 | 11 | 4 |
| other | Urinary Tract Infection | Infections and infestations | DMSO Instillation | 5 | 10 | 6 |
| other | High Blood Pressue | Cardiac disorders | Botox and DMSO Instillation | 1 | 11 | 1 |
| other | High Blood Pressue | Cardiac disorders | DMSO Instillation | 0 | 10 | 0 |
| other | Rash | Skin and subcutaneous tissue disorders | Botox and DMSO Instillation | 1 | 11 | 1 |
| other | Rash | Skin and subcutaneous tissue disorders | DMSO Instillation | 0 | 10 | 0 |
| other | Had fall, unable to walk | Injury, poisoning and procedural complications | Botox and DMSO Instillation | 1 | 11 | 1 |
| other | Had fall, unable to walk | Injury, poisoning and procedural complications | DMSO Instillation | 0 | 10 | 0 |
| other | Bladder spasms after instillation | Renal and urinary disorders | Botox and DMSO Instillation | 0 | 11 | 0 |
| other | Bladder spasms after instillation | Renal and urinary disorders | DMSO Instillation | 1 | 10 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Botox and DMSO Instillation | ||
| Total, all-cause mortality | DMSO Instillation | ||
| Total, other adverse events | Botox and DMSO Instillation | 6 | 11 |
| Total, other adverse events | DMSO Instillation | 7 | 10 |
| Total, serious adverse events | Botox and DMSO Instillation | 0 | 11 |
| Total, serious adverse events | DMSO Instillation | 2 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19648387 | BACKGROUND |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Botox and DMSO Instillation vs DMSO Instillation: 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.
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/NCT00667095
GET https://conductscience.org/api/trials/v1/NCT00667095/results?page=2