Overactive BladderDRIVENCT00465894
Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms
A study testing Extended Release Tolterodine LA and Intra Vaginal Estradiol Cream in people with Overactive Bladder, run by University of Alabama at Birmingham.
Trial summary
The purpose of this study is to determine if long acting tolterodine confers more benefit than intravaginal low dose estrogen in the treatment of Overactive Bladder Syndrome at 12 weeks post-treatment initiation. Read more about this study
- Who is it for?
- Ages 40 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Extended Release Tolterodine LA and Intra Vaginal Estradiol Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Dec 2011
- Phase
- Interventional
- 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 40 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Irritative voiding symptoms to include sensory urgency, frequency, urge incontinence, nocturia
- Postmenopausal women with a prior oophorectomy or 1 year from last menstrual period
- Women age 40-90
- Women with hysterectomy with preserved ovaries must be age 55 or greater or have a documented follicle-stimulating hormone (FSH)>40 to ensure post-menopausal status
- Community dwelling
- Ambulatory
- Ability to participate in a 12 month study
Who cannot join
- Post-void residual volume>150ml
- Glaucoma without ophthalmologist clearance
- Hormone replacement therapy in the past 6 months
- Current anticholinergic treatment
- Breast cancer
- Impaired mental status
Show all 17Show fewer
- Undiagnosed vaginal bleeding in the past 12 months
- Endometrial thickness on pelvic ultrasound >5mm
- History of thromboembolic event
- Gynecologic cancer
- Untreated urinary tract infection (would be eligible after treatment)
- Stage III pelvic organ prolapse or greater
- Recent diuretic medication changes (one month from change)
- Neurologic condition affecting bladder function (Multiple Sclerosis, Parkinsons, spinal cord injury, spina bifida)
- Congestive heart failure
- Prior pelvic irradiation
- Interstitial cystitis
About this study
Official title: Randomized Controlled Trial of Tolterodine in Combination With or Without Low-Dose Intravaginal Estradiol Cream for the Treatment of Overactive Bladder in Post-Menopausal Women
The purpose of this study is to determine if long acting tolterodine confers more benefit than intravaginal low dose estrogen in the treatment of Overactive Bladder Syndrome at 12 weeks post-treatment initiation. The hypothesis is that low dose intra-vaginal estrogen confers greater benefit than tolterodine in the treatment of Overactive Bladder symptoms. Secondary outcomes were to assess if the addition of the other therapy to the treatment regimen conferred benefit at 24 weeks and 52 weeks.
Read the detailed description
Lower urinary tract bladder storage symptoms include urinary frequency, urinary urgency, nocturia and urge incontinence. Overactive Bladder (OAB)Syndrome is a condition in which urgency is the predominant symptom with or without urge incontinence and is usually accompanied by frequency and nocturia. The mainstay of treatment of women with OAB syndrome is treatment with anticholinergic medication as well as behavioral therapy. This method of treatment has demonstrated a 60% response rate as reported in the Cochrane Database of Systemic Reviews.
In addition to anticholinergic therapy, vaginal atrophy is often corrected as part of a pharmacologic treatment plan. Vaginal atrophy is a condition this is vastly prevalent in post-menopausal women. It is thought to affect up to 48% of post-menopausal women. Many women with this condition experience vaginal dryness, irritation, painful intercourse, as well as urinary symptoms including dysuria, urgency, frequency, nocturia, incontinence and recurrent urinary tract infections.
Comparison: Tolterodine LA compared to low dose intra-vaginal estrogen cream for the treatment of OAB symptoms
- Conditions
- Overactive Bladder
- Being tested
- Extended Release Tolterodine LA, Intra Vaginal Estradiol Cream
- Keywords
- overactive bladder, urge leakage, nightime urination, incontinence, urinary frequency
- 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.
Extended Release Tolterodine LADrug
Also called Detrol
Tolterodine LA 4 mg once daily for 52 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks
Intra Vaginal Estradiol CreamDrug
Also called Estrace, Premarin vaginal cream
17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Extended Release Tolterodine LA | Active comparator | An anti-muscarinic drug that is used for symptomatic treatment of urinary incontinence. Receives: Drug: Extended Release Tolterodine LA |
| Intra Vaginal Estradiol Cream | Active comparator | For topical application to the vaginal area to treat symptoms of urgency or irritation with urination. Receives: Drug: Intra Vaginal Estradiol Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.
Measured: From baseline through 12 Weeks of Intervention
Secondary outcomes (12)
Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL)
Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.
Measured: From baseline through 12 Weeks of Intervention
Evaluate Subjective Patient Change in Irritative Urinary Symptoms
Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse.
Frequencies of each response was reported. Each level achieved (movement towards 1), is considered an improvement.
Measured: From baseline through 12 Weeks of Intervention
Subjective Patient Change in Irritative Urinary Symptoms
This was measured using the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied.
Measured: From baseline through 12 Weeks of Intervention
Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary
Number of voids and accidents/leakage per 3 day diary. A void is a voluntary and intentional event. An accident is involuntary and unintentional.
Measured: From baseline through 12 weeks of Intervention
Subjective Patient Change in Irritative Urinary Symptoms
The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.
Measured: Baseline to 24 weeks
Subjective Patient Change in Irritative Urinary Symptoms
Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.
Measured: Baseline to 24 weeks
Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)
Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement.
Measured: Baseline through 24 weeks
Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
As measured by the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied.
Measured: Baseline through 24 weeks
Subjective Patient Change in Irritative Urinary Symptoms
The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.
Measured: Baseline through 52 weeks
Subjective Patient Change in Irritative Urinary Symptoms
Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.
Measured: Baseline through 52 weeks
Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)
Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement.
Measured: Baseline through 52 weeks
Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
As measured by the Patient Satisfaction Questionnaire (PSQ).The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied.
Measured: Baseline through 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionJul 2010
- Study completionDec 2011
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 University of Alabama at BirminghamThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, David Rich Ellington, University of Alabama at Birmingham
- Investigators
- Kimberly Gerten, M.D., Principal investigator, Park Nicollette, St. Louis, MinnesotaHolly E. Richter, Ph.D., M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465894
- Sponsor's protocol ID
- F061208008
- Other IDs
- IIR - DRIVE
- Acronym
- DRIVE
- Status last verified
- Oct 2018
- First submitted
- 23 Apr 2007
- Last updated
- 1 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ellington DR, Szychowski JM, Malek JM, Gerten KA, Burgio KL, Richter HE. Combined Tolterodine and Vaginal Estradiol Cream for Overactive Bladder Symptoms After Randomized Single-Therapy Treatment. Female Pelvic Med Reconstr Surg. 2016 Jul-Aug;22(4):254-60. doi: 10.1097/SPV.0000000000000256.
PubMed 26945271
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Tolterodine in Combination With or Without Low-Dose Intravaginal Estradiol Cream for the Treatment of Overactive Bladder in Post-Menopausal Women
- ClinicalTrials.gov ID
- NCT00465894
- Acronym / sponsor ID
- DRIVE / F061208008
- Conditions
- Overactive Bladder
- Keywords
- overactive bladder, urge leakage, nightime urination, incontinence, urinary frequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Apr 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Apr 2007 (estimated)
- Results
- Posted 23 Oct 2012
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 if long acting tolterodine confers more benefit than intravaginal low dose estrogen in the treatment of Overactive Bladder Syndrome at 12 weeks post-treatment initiation. The hypothesis is that low dose intra-vaginal estrogen confers greater benefit than tolterodine in the treatment of Overactive Bladder symptoms. Secondary outcomes were to assess if the addition of the other therapy to the treatment regimen conferred benefit at 24 weeks and 52 weeks.
Detailed description
Lower urinary tract bladder storage symptoms include urinary frequency, urinary urgency, nocturia and urge incontinence. Overactive Bladder (OAB)Syndrome is a condition in which urgency is the predominant symptom with or without urge incontinence and is usually accompanied by frequency and nocturia. The mainstay of treatment of women with OAB syndrome is treatment with anticholinergic medication as well as behavioral therapy. This method of treatment has demonstrated a 60% response rate as reported in the Cochrane Database of Systemic Reviews.
In addition to anticholinergic therapy, vaginal atrophy is often corrected as part of a pharmacologic treatment plan. Vaginal atrophy is a condition this is vastly prevalent in post-menopausal women. It is thought to affect up to 48% of post-menopausal women. Many women with this condition experience vaginal dryness, irritation, painful intercourse, as well as urinary symptoms including dysuria, urgency, frequency, nocturia, incontinence and recurrent urinary tract infections.
Comparison: Tolterodine LA compared to low dose intra-vaginal estrogen cream for the treatment of OAB symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Release Tolterodine LA | Active comparator | Drug: Extended Release Tolterodine LAAn anti-muscarinic drug that is used for symptomatic treatment of urinary incontinence. |
| Intra Vaginal Estradiol Cream | Active comparator | Drug: Intra Vaginal Estradiol CreamFor topical application to the vaginal area to treat symptoms of urgency or irritation with urination. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Irritative voiding symptoms to include sensory urgency, frequency, urge incontinence, nocturia
- Postmenopausal women with a prior oophorectomy or 1 year from last menstrual period
- Women age 40-90
- Women with hysterectomy with preserved ovaries must be age 55 or greater or have a documented follicle-stimulating hormone (FSH)>40 to ensure post-menopausal status
- Community dwelling
Key exclusion criteria (17 listed)
- Post-void residual volume>150ml
- Glaucoma without ophthalmologist clearance
- Hormone replacement therapy in the past 6 months
- Current anticholinergic treatment
- Breast cancer
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 |
|---|---|---|
| Extended Release Tolterodine LAAlso: DetrolTolterodine LA 4 mg once daily for 52 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks | Drug | Extended Release Tolterodine LA |
| Intra Vaginal Estradiol CreamAlso: Estrace, Premarin vaginal cream17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks. | Drug | Intra Vaginal Estradiol Cream |
Primary outcome
Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Time frame: From baseline through 12 Weeks of Intervention
The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.
12 secondary outcomes
Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL)
Time frame: From baseline through 12 Weeks of Intervention
Evaluate Subjective Patient Change in Irritative Urinary Symptoms
Time frame: From baseline through 12 Weeks of Intervention
Subjective Patient Change in Irritative Urinary Symptoms
Time frame: From baseline through 12 Weeks of Intervention
Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary
Time frame: From baseline through 12 weeks of Intervention
Subjective Patient Change in Irritative Urinary Symptoms
Time frame: Baseline to 24 weeks
Subjective Patient Change in Irritative Urinary Symptoms
Time frame: Baseline to 24 weeks
Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)
Time frame: Baseline through 24 weeks
Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
Time frame: Baseline through 24 weeks
Subjective Patient Change in Irritative Urinary Symptoms
Time frame: Baseline through 52 weeks
Subjective Patient Change in Irritative Urinary Symptoms
Time frame: Baseline through 52 weeks
Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)
Time frame: Baseline through 52 weeks
Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
Time frame: Baseline through 52 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26945271Ellington DR, Szychowski JM, Malek JM, Gerten KA, Burgio KL, Richter HE. Combined Tolterodine and Vaginal Estradiol Cream for Overactive Bladder Symptoms After Randomized Single-Therapy Treatment. Female Pelvic Med Reconstr Surg. 2016 Jul-Aug;22(4):254-60. doi: 10.1097/SPV.0000000000000256.
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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.
Kimberly Gerten, M.D. principal investigator
Park Nicollette, St. Louis, Minnesota
Holly E. Richter, Ph.D., M.D. principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Extended Release Tolterodine LA and Intra Vaginal Estradiol Cream in people with Overactive Bladder, run by University of Alabama at Birmingham.
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 17 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: finished, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2012). 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?
Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score (time frame: From baseline through 12 Weeks of Intervention). 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 NCT00465894, 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 1 Nov 2018.