Overactive BladderPhase 3NCT00667095
Over Active Bladder Instillation Study - Botox
A Phase 3 study testing Botox Instillation and DMSO Instillation in people with Overactive Bladder and Urinary Urge Incontinence, run by Mayo Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder, Urinary Urge Incontinence, Urinary Incontinence
- What is being tested?
- Botox Instillation and DMSO Instillation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jan 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patient aged 18 years or older
- No evidence of stress urinary incontinence on physical examination or urodynamics
- Patients who have failed prior drug therapy for overactive bladder or detrusor hyperreflexia
- Patients with symptoms and signs of OAB, detrusor hyperreflexia, urinary urgency, urinary urge incontinence.
- Patient who is mentally competent with the ability to understand and comply with the requirements of the study
- Patient who agrees to be available for the follow-up evaluations as required by the protocol
- Patient who has given signed informed consent
Who cannot join
- Patient with Post-Void Residual Urine (PVRU) greater than 100 ml on repeated measures. (Patient with a single PVRU of >100 ml and followed by two consecutive PVRU measurements of <100 ml may be included in the study)
- Patient with greater than vesicoureteral reflux grade 1, interstitial cystitis, genitourinary fistulae
- Patient with pelvic organ prolapse stage III or IV, i.e. the most distal part of the prolapse protruding more than 1 cm beyond the hymen (>+1), at straining
- Patient with un-investigated hematuria
- Patient with lower tract genitourinary malignancies
- Patient on current medication for stress urinary incontinence, such as alpha-adrenergic agonists or duloxetine, within three weeks prior to completing the baseline Bladder Diary (estrogen therapy on a stable dose for at least two months prior to study start is allowed)
Show all 19Show fewer
- Patient with ongoing complications of prior anti-incontinence surgery
- Patient who is pregnant, lactating, or planning to become pregnant within the study period
- Patient who has received pelvic radiation
- Patient with any condition, which could lead to significant postoperative complications, including current infection and uncontrolled diabetes.
- Patient who is morbidly obese (defined as BMI > 40 Kg/m2)
- Patient who is bedridden, institutionalized or in such physical condition that she cannot move to the closest bathroom without assistance from another person
- Patient with current or acute urinary tract infection, including cystitis or urethritis. (Patient with such infections should be treated with antibiotics, with subsequent urinalysis tests confirming the absence of such infection before study inclusion)
- Patient with any condition that would preclude treatment due to contraindications and/or warnings in the study product's labeling
- Patient on immunomodulatory therapy (suppressive or stimulatory)
- Patient with known lidocaine hypersensitivity or hypersensitivity to any anesthetics to be used during the treatment session/surgical procedure
- Patient with a concurrent use of another study product within two weeks prior to study start, or who concurrently participate in any other clinical study
- Any disease that in the opinion of the Investigator would make the patient unsuitable for the study
- Patient with a life expectancy of less than 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Botulinum-A Toxin/DMSO Instillation in the Treatment of Women With Over Active Bladder (OAB) Syndrome and/or Urinary Urge Incontinence
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.
Read the detailed description
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.
- Conditions
- Overactive Bladder, Urinary Urge Incontinence, Urinary Incontinence, Detrusor Hyperreflexia, Urge Incontinence
- Being tested
- Botox Instillation, DMSO Instillation
- Keywords
- OAB, Over Active Bladder, overactive bladder, Urinary Urge Incontinence, Urinary Incontinence, Botox, DMSO, bladder instillation, instillation, detrusor hyperreflexia, urge incontinence
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox InstillationDrug
Also called Botulinum-A Toxin, Botox
Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO InstillationDrug
Also called Dimethyl Sulfoxide, DMSO
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.
| Study group | Role | What they receive |
|---|---|---|
| Botox and DMSO instillation | Experimental | Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution Receives: Drug: Botox Instillation; Drug: DMSO Instillation |
| DMSO instillation | Placebo comparator | Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters Receives: Drug: DMSO Instillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 3 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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."
Measured: Baseline, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Study terminated early due to PI's extended medical leave.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Steven P Petrou, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667095
- Sponsor's protocol ID
- 07-007399
- Status last verified
- Jul 2014
- First submitted
- 23 Apr 2008
- Last updated
- 11 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Petrou SP, Parker AS, Crook JE, Rogers A, Metz-Kudashick D, Thiel DD. Botulinum a toxin/dimethyl sulfoxide bladder instillations for women with refractory idiopathic detrusor overactivity: a phase 1/2 study. Mayo Clin Proc. 2009 Aug;84(8):702-6. doi: 10.4065/84.8.702.
PubMed 19648387
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Botulinum-A Toxin/DMSO Instillation in the Treatment of Women With Over Active Bladder (OAB) Syndrome and/or Urinary Urge Incontinence
- ClinicalTrials.gov ID
- NCT00667095
- Acronym / sponsor ID
- 07-007399
- Conditions
- Overactive Bladder, Urinary Urge Incontinence, Urinary Incontinence, Detrusor Hyperreflexia, Urge Incontinence
- Keywords
- OAB, Over Active Bladder, overactive bladder, Urinary Urge Incontinence, Urinary Incontinence, Botox, DMSO, bladder instillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early due to PI's extended medical leave.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 Apr 2008 (estimated)
- Results
- Posted 11 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox and DMSO instillation | Experimental | Drug: Botox Instillation, Drug: DMSO InstillationBotulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution |
| DMSO instillation | Placebo comparator | Drug: DMSO InstillationDimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patient aged 18 years or older
- No evidence of stress urinary incontinence on physical examination or urodynamics
- Patients who have failed prior drug therapy for overactive bladder or detrusor hyperreflexia
- Patients with symptoms and signs of OAB, detrusor hyperreflexia, urinary urgency, urinary urge incontinence.
- Patient who is mentally competent with the ability to understand and comply with the requirements of the study
Key exclusion criteria (19 listed)
- Patient with Post-Void Residual Urine (PVRU) greater than 100 ml on repeated measures. (Patient with a single PVRU of >100 ml and followed by two consecutive PVRU measurements of <100 ml may be included in the study)
- Patient with greater than vesicoureteral reflux grade 1, interstitial cystitis, genitourinary fistulae
- Patient with pelvic organ prolapse stage III or IV, i.e. the most distal part of the prolapse protruding more than 1 cm beyond the hymen (>+1), at straining
- Patient with un-investigated hematuria
- Patient with lower tract genitourinary malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botox InstillationAlso: Botulinum-A Toxin, BotoxBotox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided. | Drug | Botox and DMSO instillation |
| DMSO InstillationAlso: Dimethyl Sulfoxide, DMSODMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided. | Drug | Botox and DMSO instillation, DMSO instillation |
Primary outcome
Change in Incontinence Quality of Life (I-QoL) Score
Time frame: 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.
5 secondary outcomes
Change in Incontinence Impact Questionnaire Short Form (IIQ-7)
Time frame: baseline, 1 month, 3 months
Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF)
Time frame: baseline, 1 month, 3 months
Change in Urogenital Distress Inventory (UDI-6)
Time frame: baseline, 1 month, 3 months
Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 3 Months
Time frame: baseline, 1 month, 3 months
Number of Participants With a Decrease in Urinary Urgency at 1 Month and 3 Months
Time frame: Baseline, 1 month, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19648387Petrou SP, Parker AS, Crook JE, Rogers A, Metz-Kudashick D, Thiel DD. Botulinum a toxin/dimethyl sulfoxide bladder instillations for women with refractory idiopathic detrusor overactivity: a phase 1/2 study. Mayo Clin Proc. 2009 Aug;84(8):702-6. doi: 10.4065/84.8.702.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven P Petrou, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botox Instillation and DMSO Instillation in people with Overactive Bladder and Urinary Urge Incontinence, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Incontinence Quality of Life (I-QoL) Score (time frame: Baseline, 1 month, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00667095, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014.