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Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms (DRIVE)

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ClinicalTrials.gov Identifier: NCT00465894
Recruitment Status : Completed
First Posted : April 25, 2007
Results First Posted : October 23, 2012
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
David Rich Ellington, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: Extended Release Tolterodine LA Drug: Intra Vaginal Estradiol Cream Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : December 2011


Arm Intervention/treatment
Active Comparator: Extended Release Tolterodine LA
An anti-muscarinic drug that is used for symptomatic treatment of urinary incontinence.
Drug: Extended Release Tolterodine LA
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
Other Name: Detrol

Active Comparator: Intra Vaginal Estradiol Cream
For topical application to the vaginal area to treat symptoms of urgency or irritation with urination.
Drug: Intra Vaginal Estradiol 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.
Other Names:
  • Estrace
  • Premarin vaginal cream




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Evaluate Subjective Patient Change in Irritative Urinary Symptoms [ Time Frame: From baseline through 12 Weeks of Intervention ]

    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.


  3. Subjective Patient Change in Irritative Urinary Symptoms [ Time Frame: From baseline through 12 Weeks of Intervention ]
    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.

  4. Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary [ Time Frame: From baseline through 12 weeks of Intervention ]
    Number of voids and accidents/leakage per 3 day diary. A void is a voluntary and intentional event. An accident is involuntary and unintentional.

  5. Subjective Patient Change in Irritative Urinary Symptoms [ Time Frame: Baseline to 24 weeks ]
    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.

  6. Subjective Patient Change in Irritative Urinary Symptoms [ Time Frame: Baseline to 24 weeks ]
    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.

  7. Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) [ Time Frame: Baseline through 24 weeks ]
    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.

  8. Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) [ Time Frame: Baseline through 24 weeks ]
    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.

  9. Subjective Patient Change in Irritative Urinary Symptoms [ Time Frame: Baseline through 52 weeks ]
    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.

  10. Subjective Patient Change in Irritative Urinary Symptoms [ Time Frame: Baseline through 52 weeks ]
    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.

  11. Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) [ Time Frame: Baseline through 52 weeks ]
    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.

  12. Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) [ Time Frame: Baseline through 52 Weeks ]
    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.



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465894


Sponsors and Collaborators
University of Alabama at Birmingham
Pfizer
Investigators
Layout table for investigator information
Principal Investigator: Kimberly Gerten, M.D. Park Nicollette, St. Louis, Minnesota
Principal Investigator: Holly E. Richter, Ph.D., M.D. University of Alabama at Birmingham
  Study Documents (Full-Text)

Documents provided by David Rich Ellington, University of Alabama at Birmingham:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Rich Ellington, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00465894    
Other Study ID Numbers: F061208008
IIR - DRIVE
First Posted: April 25, 2007    Key Record Dates
Results First Posted: October 23, 2012
Last Update Posted: November 1, 2018
Last Verified: October 2018
Keywords provided by David Rich Ellington, University of Alabama at Birmingham:
overactive bladder
urge leakage
nightime urination
incontinence
urinary frequency
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Tolterodine Tartrate
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents