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Detrol 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 30, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Overactive Bladder Drug: Tolterodine LA Drug: Estrace Vaginal Cream

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

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 Intra-Vaginal Estradiol Cream for the Treatment of Overactive Bladder in Post-Menopausal Women
Study Start Date : April 2007
Primary Completion Date : July 2010
Study Completion Date : December 2011

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Extended Release Tolterodine Drug: Tolterodine LA
Tolterodine LA 4 mg once daily for 52 weeks
Active Comparator: Intra Vaginal Estradiol Cream Drug: Estrace Vaginal Cream
17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks
Other Name: Premarin vaginal cream

Outcome Measures

Primary Outcome Measures :
  1. Subjective Patient Improvement in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at 12 Weeks Post Intervention Initiation [ Time Frame: After 12 Weeks of Intervention ]
    OAB-q scoring ranges from a lowest score of 8 to the highest score of 48. The higher score reflects greater severity of symptoms. The derived score is (actual score - lowest raw score) divided by possible raw score range (40) times 100. Hence, the lowest score is 0 and the highest score is 100, with 100 being indicative or greater symptom severity. The mean and the standard deviation is reported for both arms.

Secondary Outcome Measures :
  1. Subjective Patient Improvement in Irritative Urinary Symptoms at 12 Weeks Post Intervention Initiation [ Time Frame: After 12 Weeks of Intervention ]
    1. Health Related Quality of Life (HRQL) portion of the OAB-q
    2. Patient Global Impression of Improvement (PGI-I)
    3. Patient Satisfaction Questionnaire (PSQ)
    4. 3-Day Voiding Diary

  2. Subjective Patient Improvement in Irritative Urinary Symptoms at 24 and 52 Weeks Post Intervention Initiation [ Time Frame: After 24 and 52 Weeks of Intervention ]
    1. OAB-q Symptom Bother Score
    2. Health Related Quality of Life (HRQL) portion of the OAB-q
    3. Patient Global Impression of Improvement (PGI-I)
    4. Patient Satisfaction Questionnaire (PSQ)

Eligibility Criteria

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

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 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
Contacts and Locations

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
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Holly Richter, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00465894     History of Changes
Other Study ID Numbers: F061208008
First Posted: April 25, 2007    Key Record Dates
Results First Posted: October 23, 2012
Last Update Posted: November 30, 2017
Last Verified: October 2017

Keywords provided by Holly Richter, MD, University of Alabama at Birmingham:
overactive bladder
urge leakage
nightime urination
urinary frequency

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Tolterodine Tartrate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents