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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Holly Richter, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00465894
First received: April 23, 2007
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Overactive Bladder
Drug: Tolterodine LA
Drug: Estrace Vaginal Cream

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
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

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Subjective Patient Improvement in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) After 12 Weeks Intervention [ Time Frame: After 12 weeks of intervention ] [ Designated as safety issue: No ]
    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 highest score is 100, with 100 being indicative of greater symptom severity. The mean and the standard deviation is reported for both arms.


Secondary Outcome Measures:
  • Subjective Patient Improvement in Irritative Urinary Symptoms at 1 Year of Treatment by the OAB-Q Questionnaire [ Time Frame: after 1 year of treatment ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: April 2007
Study Completion Date: December 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Women who also have some stress urinary symptoms as reported on the MESA questionnaire
Drug: Tolterodine LA
Tolterodine LA 4 mg once daily for 52 weeks
Active Comparator: 2
Women with only urge urinary symptoms
Drug: Estrace Vaginal Cream
17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks
Other Names:
  • Estrace vaginal cream
  • Premarin 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

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465894

Sponsors and Collaborators
University of Alabama at Birmingham
Pfizer
Investigators
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

No publications provided

Responsible Party: Holly Richter, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00465894     History of Changes
Other Study ID Numbers: F061208008, IIR - DRIVE
Study First Received: April 23, 2007
Results First Received: June 1, 2012
Last Updated: September 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
overactive bladder
urge leakage
nightime urination
incontinence
urinary frequency

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

ClinicalTrials.gov processed this record on November 20, 2014