Back to resultsDetrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms (DRIVE)
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Extended Release Tolterodine LA
Intra Vaginal Estradiol Cream
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring overactive bladder, urge leakage, nightime urination, incontinence, urinary frequency
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Extended Release Tolterodine LA
Intra Vaginal Estradiol Cream
Arm Description
An anti-muscarinic drug that is used for symptomatic treatment of urinary incontinence.
For topical application to the vaginal area to treat symptoms of urgency or irritation with urination.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT00465894
First Posted
April 23, 2007
Last Updated
October 1, 2018
Sponsor
University of Alabama at Birmingham
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00465894
Brief Title
Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms
Acronym
DRIVE
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
overactive bladder, urge leakage, nightime urination, incontinence, urinary frequency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Extended Release Tolterodine LA
Arm Type
Active Comparator
Arm Description
An anti-muscarinic drug that is used for symptomatic treatment of urinary incontinence.
Arm Title
Intra Vaginal Estradiol Cream
Arm Type
Active Comparator
Arm Description
For topical application to the vaginal area to treat symptoms of urgency or irritation with urination.
Intervention Type
Drug
Intervention Name(s)
Extended Release Tolterodine LA
Other Intervention Name(s)
Detrol
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Intra Vaginal Estradiol Cream
Other Intervention Name(s)
Estrace, Premarin vaginal cream
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Description
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.
Time Frame
From baseline through 12 Weeks of Intervention
Secondary Outcome Measure Information:
Title
Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL)
Description
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.
Time Frame
From baseline through 12 Weeks of Intervention
Title
Evaluate Subjective Patient Change in Irritative Urinary Symptoms
Description
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.
Time Frame
From baseline through 12 Weeks of Intervention
Title
Subjective Patient Change in Irritative Urinary Symptoms
Description
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.
Time Frame
From baseline through 12 Weeks of Intervention
Title
Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary
Description
Number of voids and accidents/leakage per 3 day diary. A void is a voluntary and intentional event. An accident is involuntary and unintentional.
Time Frame
From baseline through 12 weeks of Intervention
Title
Subjective Patient Change in Irritative Urinary Symptoms
Description
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.
Time Frame
Baseline to 24 weeks
Title
Subjective Patient Change in Irritative Urinary Symptoms
Description
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.
Time Frame
Baseline to 24 weeks
Title
Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)
Description
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.
Time Frame
Baseline through 24 weeks
Title
Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
Description
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.
Time Frame
Baseline through 24 weeks
Title
Subjective Patient Change in Irritative Urinary Symptoms
Description
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.
Time Frame
Baseline through 52 weeks
Title
Subjective Patient Change in Irritative Urinary Symptoms
Description
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.
Time Frame
Baseline through 52 weeks
Title
Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)
Description
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.
Time Frame
Baseline through 52 weeks
Title
Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
Description
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.
Time Frame
Baseline through 52 Weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Gerten, M.D.
Organizational Affiliation
Park Nicollette, St. Louis, Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Holly E. Richter, Ph.D., M.D.
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
26945271
Citation
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.
Results Reference
derived
Learn more about this trial
Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms
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