Overactive BladderPhase 4NCT01613170
Premarin Versus Toviaz for Treatment of Overactive Bladder
A Phase 4 study testing Toviaz and Premarin in people with Overactive Bladder, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The use of vaginal estrogen cream in conjunction with Toviaz will be more effective than the use of Toviaz alone for the treatment of overactive bladder. Read more about this study
- Who is it for?
- Ages 30 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Toviaz and Premarin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 30 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal Women defined as at least 12 months since last menstrual period
- OAB symptoms for 6 months or longer with complaints of frequency (8 or more voids in a 24 hour period), and either 6 or more urgency episodes in 24 hours, and either 3 or more urge urinary incontinence episodes per 24 hours.
Who cannot join
- Current or recent treatment (within the last 6 months) with estrogens
- Past or present history of estrogen dependent neoplasm
- Undiagnosed genital tract bleeding
- Current urinary or vaginal infection
- History of thromboembolic disorders associated with estrogen use
- Commencement or alteration of diuretic therapy within three months of study enrollment
Show all 15Show fewer
- No contraindications for anticholinergic medical therapy
- No contraindications to estrogen therapy
- Symptoms must not have commenced more than three years prior to menopause
- Post Void Residual must be under or equal to 150 ml
- Recurrent Urinary Tract Infections (3 culture proven UTI's within the past 12 months)
- Not on any other anticholinergic medications for the last 4 weeks
- Painful Bladder Syndrome
- Chronic Pelvic Pain
- Vaginal Prolapse POPQ > stage 2/ maximal prolapse point greater than +1 cm
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
Alexandriah Alas, MD, 954-659-6342, alasa@ccf.org
GW Davila, MD
About this study
Official title: A Combined Treatment Program for the Symptoms of Urinary Urgency and Frequency With Toviaz and Premarin Vaginal Cream
The use of vaginal estrogen cream in conjunction with Toviaz will be more effective than the use of Toviaz alone for the treatment of overactive bladder.
Read the detailed description
Participants will be randomized to two treatment arms with 45 patients enrolled in each study arm: Toviaz and Premarin Vaginal Cream and Toviaz and Placebo Premarin Vaginal Cream. The Toviaz will be dosed at 4mg tablet given as a once daily dose. Premarin vaginal cream will be dosed at 1 gram per vagina twice weekly. Compliance will be assessed at the 4-week mark and again at completion of the study, 8 weeks after the commencement of treatment.
The questionnaires chosen for this study have been designed and validated as effective tools to assess and evaluate OAB. Patients will be asked to complete three symptoms questionnaires and a 3-day voiding dairy. The questionnaires include Overactive Bladder Questionnaire (OAB-q), The Patient Perception of Bladder Condition, and Urgency Severity and Impact Questionnaire. The voiding diary and questionnaires will be filled out and collected at the initial visit and again at the end of the study which is defined as 8 weeks after the commencement of treatment.
Additionally, patients will be asked to rate their symptoms associated with urogenital atrophy at the start of the study and then again at 8 weeks. The severity of each symptom will be graded based on a four-point scale (0=none, 1=mild, 2= moderate, 3=severe) and a composite score will then be generated. Examiners will also rate the severity of signs of urogenital atrophy at the first visit and at the conclusion of the study.
An objective evaluation of the effectiveness of the estrogen cream treatment will be accomplished by a pathological evaluation of the vaginal cell samples at the beginning of treatment and then again at the 8 week point. These cells will be collected and analyzed by an independent pathologist to determine the percentage of parabasal, intermediate, and superficial cells and to document the change in these three categories of cells as a result of the vaginal estrogen treatment. A 3-Day voiding diary will be used to document changes from baseline for urinary urgency, frequency, and incontinence episodes. Based on previous studies we predict there will be a 45% improvement on urinary frequency from baseline when using both Toviaz and vaginal Premarin cream. Secondary outcomes will be measured using the following validated questionnaires given at the start of the study and again at completion: OAB-q, Patient Perception of Bladder Condition, Urgency Severity and Impact Questionnaire.
- Conditions
- Overactive Bladder
- Being tested
- Toviaz, Premarin, Placebo cream
- Keywords
- Overactive Bladder, Vaginal Estrogen, Anticholinergics, Antimuscarinics
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToviazDrug
Also called fesoteridine
Toviaz 4mg daily
PremarinDrug
Also called estrogen, conjugated vaginal
Premarin cream 1 g per vagina twice weekly
Placebo creamDrug
Also called Verba base cream
Placebo cream 1 g per vagina twice weekly, to mimic Premarin cream
| Study group | Role | What they receive |
|---|---|---|
| Toviaz and Premarin Vaginal Cream | Experimental | Toviaz 4 mg PO q day and premarin cream 1 g per vagina 2 times a week. Receives: Drug: Toviaz; Drug: Premarin |
| Toviaz , Placebo Premarin Vaginal Cream | Placebo comparator | Toviaz 4 mg PO q day and placebo cream 1 g per vagina 2 times a week. Receives: Drug: Toviaz; Drug: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary frequency as measured by a 3 day voiding diary
number of voids per day
Measured: 1 year
Secondary outcomes (1)
Lifestyle Impact of Overactive Bladder as measured using 3 validated questionnaires: OAB-Q, PPBC, and Urgency Severity and Impact Questionnaire
quality of life assessment via questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by The Cleveland 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, G. Willy Davila, The Cleveland Clinic
- Investigators
- Eric Hurtado, MD, Principal investigator, Cleveland Clinic FloridaAlexandriah Alas, MD, Study director, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613170
- Sponsor's protocol ID
- 11074
- Status last verified
- Apr 2017
- First submitted
- 24 May 2012
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Treatment Program for the Symptoms of Urinary Urgency and Frequency With Toviaz and Premarin Vaginal Cream
- ClinicalTrials.gov ID
- NCT01613170
- Acronym / sponsor ID
- 11074
- Conditions
- Overactive Bladder
- Keywords
- Overactive Bladder, Vaginal Estrogen, Anticholinergics, Antimuscarinics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Apr 2012
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of vaginal estrogen cream in conjunction with Toviaz will be more effective than the use of Toviaz alone for the treatment of overactive bladder.
Detailed description
Participants will be randomized to two treatment arms with 45 patients enrolled in each study arm: Toviaz and Premarin Vaginal Cream and Toviaz and Placebo Premarin Vaginal Cream. The Toviaz will be dosed at 4mg tablet given as a once daily dose. Premarin vaginal cream will be dosed at 1 gram per vagina twice weekly. Compliance will be assessed at the 4-week mark and again at completion of the study, 8 weeks after the commencement of treatment.
The questionnaires chosen for this study have been designed and validated as effective tools to assess and evaluate OAB. Patients will be asked to complete three symptoms questionnaires and a 3-day voiding dairy. The questionnaires include Overactive Bladder Questionnaire (OAB-q), The Patient Perception of Bladder Condition, and Urgency Severity and Impact Questionnaire. The voiding diary and questionnaires will be filled out and collected at the initial visit and again at the end of the study which is defined as 8 weeks after the commencement of treatment.
Additionally, patients will be asked to rate their symptoms associated with urogenital atrophy at the start of the study and then again at 8 weeks. The severity of each symptom will be graded based on a four-point scale (0=none, 1=mild, 2= moderate, 3=severe) and a composite score will then be generated. Examiners will also rate the severity of signs of urogenital atrophy at the first visit and at the conclusion of the study.
An objective evaluation of the effectiveness of the estrogen cream treatment will be accomplished by a pathological evaluation of the vaginal cell samples at the beginning of treatment and then again at the 8 week point. These cells will be collected and analyzed by an independent pathologist to determine the percentage of parabasal, intermediate, and superficial cells and to document the change in these three categories of cells as a result of the vaginal estrogen treatment. A 3-Day voiding diary will be used to document changes from baseline for urinary urgency, frequency, and incontinence episodes. Based on previous studies we predict there will be a 45% improvement on urinary frequency from baseline when using both Toviaz and vaginal Premarin cream. Secondary outcomes will be measured using the following validated questionnaires given at the start of the study and again at completion: OAB-q, Patient Perception of Bladder Condition, Urgency Severity and Impact Questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toviaz and Premarin Vaginal Cream | Experimental | Drug: Toviaz, Drug: PremarinToviaz 4 mg PO q day and premarin cream 1 g per vagina 2 times a week. |
| Toviaz , Placebo Premarin Vaginal Cream | Placebo comparator | Drug: Toviaz, Drug: Placebo creamToviaz 4 mg PO q day and placebo cream 1 g per vagina 2 times a week. |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal Women defined as at least 12 months since last menstrual period
- OAB symptoms for 6 months or longer with complaints of frequency (8 or more voids in a 24 hour period), and either 6 or more urgency episodes in 24 hours, and either 3 or more urge urinary incontinence episodes per 24 hours.
Key exclusion criteria (15 listed)
- Current or recent treatment (within the last 6 months) with estrogens
- Past or present history of estrogen dependent neoplasm
- Undiagnosed genital tract bleeding
- Current urinary or vaginal infection
- History of thromboembolic disorders associated with estrogen use
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 |
|---|---|---|
| ToviazAlso: fesoteridineToviaz 4mg daily | Drug | Toviaz , Placebo Premarin Vaginal Cream, Toviaz and Premarin Vaginal Cream |
| PremarinAlso: estrogen, conjugated vaginalPremarin cream 1 g per vagina twice weekly | Drug | Toviaz and Premarin Vaginal Cream |
| Placebo creamAlso: Verba base creamPlacebo cream 1 g per vagina twice weekly, to mimic Premarin cream | Drug | Toviaz , Placebo Premarin Vaginal Cream |
Primary outcome
Urinary frequency as measured by a 3 day voiding diary
Time frame: 1 year
number of voids per day
1 secondary outcome
Lifestyle Impact of Overactive Bladder as measured using 3 validated questionnaires: OAB-Q, PPBC, and Urgency Severity and Impact Questionnaire
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Eric Hurtado, MD principal investigator
Cleveland Clinic Florida
Alexandriah Alas, MD study director
Cleveland Clinic Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Toviaz and Premarin in people with Overactive Bladder, run by The Cleveland 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 2 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 20 Apr 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandriah Alas, MD (954-659-6342, alasa@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary frequency as measured by a 3 day voiding diary (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2017.