A Phase 3 interventional study of Botox Instillation and DMSO Instillation in Overactive Bladder, Urinary Urge Incontinence and Urinary Incontinence, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-11.
Sponsored by Mayo Clinic · Phase 3, Interventional, and Treatment
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Among 44 studies testing botulinum toxin type A in Urinary Bladder, Overactive — 3 open to participants now, 5 under way, 1 of them phase 3. botulinum toxin type A · Urinary Bladder, Overactive.
Among the 44 studies testing botulinum toxin type A in Urinary Bladder, Overactive, this one is the 38th largest by enrollment, is one of 3 that started in 2008, is one of 16 in phase 3, and was the 11th registered.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 126 are open to participants now.
Browse Urinary Bladder, Overactive studies →3 of the 44 studies testing botulinum toxin type A in Urinary Bladder, Overactive are open now, in 2 countries. Recruiting first, the newest first:
Mackay Medical College · Sites in Taiwan
Ages 30–100 · Women only
University of South Florida · Sites in United States
Ages 18+ · Women only
Walter Reed National Military Medical Center · Sites in United States
Ages 18+ · Healthy volunteers
By country, each count listing its studies:
botulinum toxin type A: first FDA approval 1991 (BOTOX COSMETIC), first EMA approval 2019. What it is approved for, and how studies give it, is on its page →
Of the 73 Urinary Bladder, Overactive studies recruiting now, 44 (60%) set no upper age limit and 15 (21%) stop at 75 or younger; 6 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
44 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 13 · Phase 3 18 · Phase 4 10
First in 2005; this study’s year is marked. 3 started in 2008.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 25 is below the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Median enrollment 84 across the 44 interventional studies. Of the 32 that completed or were terminated, 21 (66%) have results posted.
This tab as a report to print or save as PDF → With an account.
19 of 44 have an industry lead sponsor. The 10 most frequent:
Mayo Clinic is the lead sponsor of 3,270 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Mayo Clinic has 6 studies filed under Urinary Bladder, Overactive — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 44 studies testing botulinum toxin type A in Urinary Bladder, Overactive, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to determine whether women with overactive bladder (OAB) who receive direct instillation via a catheter of a Botulinum-A Toxin (Botox) with Dimethyl Sulfoxide (DMSO) solution experience significantly better improvement of their OAB symptoms when compared to a similar group of women with OAB who receive instillation of DMSO only.
The primary objective of this study is to evaluate the efficacy of catheter-based instillation of a solution of Botox/DMSO as a novel method for treating women with overactive bladder (OAB) and secondary urinary incontinence who have failed oral pharmacologic therapy. This study will test the broad hypothesis that administration of Botox/DMSO instillations into the bladder with a urethral catheter can significantly improve symptoms and quality of life in patients with OAB when compared to DMSO installations alone. Explicitly, we hypothesize that scores on the validated Incontinence Quality of Life (I-QOL) questionnaire of women with OAB who receive Botox/DMSO instillation will be much improved at three-month follow-up compared to similar women receiving DMSO instillation alone. Our long-term goal is to offer women with detrusor hyperreflexia or OAB a less invasive alternative to surgery and an alternative to anticholinergic by mouth medications. In support of this effort, we are proposing a randomized, double-blind, placebo controlled clinical trial to be conducted in the Department of Urology at Mayo Clinic, Jacksonville, Florida.
Note: The study was terminated early in July of 2011 due to an extended medical absence of the Principal Investigator.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Drug: Botox Instillation · Drug: DMSO Instillation
Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
Drug: DMSO Instillation
Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
Also known as: Botulinum-A Toxin, Botox
DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
Also known as: Dimethyl Sulfoxide, DMSO
Change in Incontinence Quality of Life (I-QoL) Score
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.
Time frame: Baseline, 1 month, 3 months
Change in Incontinence Impact Questionnaire Short Form (IIQ-7)
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.
Time frame: baseline, 1 month, 3 months
Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF)
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.
Time frame: baseline, 1 month, 3 months
Change in Urogenital Distress Inventory (UDI-6)
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.
Time frame: baseline, 1 month, 3 months
Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 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).
Time frame: baseline, 1 month, 3 months
Number of Participants With a Decrease in Urinary Urgency at 1 Month and 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."
Time frame: Baseline, 1 month, 3 months
A total of 25 subjects were recruited from 10/21/2008 to 8/19/2010. Three of these were determined to be screen failures before randomization, and another one was withdrawn prior to randomization. Twenty one subjects were randomized: 11 to Botox/DMSO, and 10 to DMSO only.
| Milestone | Botox and DMSO Instillation | DMSO Instillation |
|---|---|---|
| Started | 11 | 10 |
| Completed | 11 | 9 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| units on a scale | Botox and DMSO Instillation | DMSO Instillation |
|---|---|---|
| Change from baseline to 1 month | 9.6 ± 13.3 | -3.9 ± 11.6 |
| Change from baseline to 3 months (n=11, 9) | 8.6 ± 14.4 | -4.0 ± 9.3 |
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.
| units on a scale | Botox and DMSO Instillation | DMSO Instillation |
|---|---|---|
| Change from baseline to 1 month | -2.5 ± 4.0 | 2.0 ± 5.9 |
| Change from baseline to 3 months (n=11, 9) | -1.8 ± 4.2 | 1.1 ± 3.8 |
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.
| units on a scale | Botox and DMSO Instillation | DMSO Instillation |
|---|---|---|
| Change from baseline to 1 month | -2.4 ± 5.8 | -0.5 ± 4.4 |
| Change from baseline to 3 months (n=11, 9) | -2.5 ± 5.1 | 0.8 ± 4.5 |
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.
| units on a scale | Botox and DMSO Instillation | DMSO Instillation |
|---|---|---|
| Change from baseline to 1 month | -1.9 ± 3.7 | -0.1 ± 1.9 |
| Change from baseline to 3 months (n=11, 9) | -0.9 ± 3.6 | -0.4 ± 3.5 |
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).
| participants | Botox and DMSO Instillation | DMSO Instillation |
|---|---|---|
| 1 month | 6 | 4 |
| 3 months (n=11, 9) | 6 | 2 |
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."
| participants | Botox and DMSO Instillation | DMSO Instillation |
|---|---|---|
| 1 month | 4 | 1 |
| 3 months (n=11, 9) | 5 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Botox and DMSO Instillation | — | 0/11 (0%) | 6/11 (54.5%) |
| DMSO Instillation | — | 2/10 (20%) | 7/10 (70%) |
| Event | Botox and DMSO Instillation | DMSO Instillation |
|---|---|---|
| Hospitalization for body jerking and termons due to oligodendroglioma.Nervous system disorders | 0/11 | 1/10 |
| Hospitalization for joint pain due to infectionInfections and infestations | 0/11 | 1/10 |
| Hospitalization for tibial ulcerInfections and infestations | 0/11 | 1/10 |
| Event | Botox and DMSO Instillation | DMSO Instillation |
|---|---|---|
| Urinary Tract InfectionInfections and infestations | 3/11 | 5/10 |
| Bladder spasms after instillationRenal and urinary disorders | 0/11 | 1/10 |
| Swollen anklesBlood and lymphatic system disorders | 0/11 | 1/10 |
| Nose BleedBlood and lymphatic system disorders | 0/11 | 1/10 |
| Left Distal Radius Fracture from a Twist and FallInjury, poisoning and procedural complications | 0/11 | 1/10 |
| High Blood PressueCardiac disorders | 1/11 | 0/10 |
| RashSkin and subcutaneous tissue disorders | 1/11 | 0/10 |
| Had fall, unable to walkInjury, poisoning and procedural complications | 1/11 | 0/10 |
| Age, Continuous(years) | Botox and DMSO Instillation | DMSO Instillation | Total |
|---|---|---|---|
| Median | 58 (36 to 85) | 71 (38 to 93) | 68 (36 to 93) |
| Sex: Female, Male(Participants) | Botox and DMSO Instillation | DMSO Instillation | Total |
|---|---|---|---|
| Female | 11 | 10 | 21 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Botox and DMSO Instillation | DMSO Instillation | Total |
|---|---|---|---|
| United States | 11 | 10 | 21 |
| Smoking Status(participants) | Botox and DMSO Instillation | DMSO Instillation | Total |
|---|---|---|---|
| Never smoked | 4 | 6 | 10 |
| Past smoker | 6 | 4 | 10 |
| Current smoker | 1 | 0 | 1 |
| History of Hypertension(participants) | Botox and DMSO Instillation | DMSO Instillation | Total |
|---|---|---|---|
| Hypertension | 6 | 7 | 13 |
| No hypertension | 5 | 3 | 8 |
| History of Urinary Tract Infections (UTIs)(participants) | Botox and DMSO Instillation | DMSO Instillation | Total |
|---|---|---|---|
| Previous history of UTIs | 10 | 10 | 20 |
| No previous UTIs | 1 | 0 | 1 |
| Number of Vaginal Births(participants) | Botox and DMSO Instillation | DMSO Instillation | Total |
|---|---|---|---|
| 0 vaginal births | 3 | 3 | 6 |
| 1-2 vaginal births | 4 | 1 | 5 |
| ≥ 3 vaginal births | 4 | 6 | 10 |
| Body Mass Index(kg/m^2) | Botox and DMSO Instillation | DMSO Instillation | Total |
|---|---|---|---|
| Median | 26 (22 to 38) | 30 (19 to 40) | 27 (19 to 40) |
4 further baseline measures are reported on the registry.
The record gives a start of Apr 2008, a primary completion of Jan 2012 and a completion of Jan 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2014, 2 years 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A