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Detrol LA vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms (DRIVE)
This study is ongoing, but not recruiting participants.
Study NCT00465894   Information provided by University of Alabama at Birmingham
First Received: April 23, 2007   Last Updated: September 3, 2009   History of Changes

April 23, 2007
September 3, 2009
April 2007
November 2009   (final data collection date for primary outcome measure)
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 ]
Subjective patient improvement in irritative urinary symptoms as measured by the Overactive Bladder Questionnaire (OAB-q) after 12 weeks intervention
Complete list of historical versions of study NCT00465894 on ClinicalTrials.gov Archive Site
Subjective patient improvement in irritative urinary symptoms at 1 year of treatment by the OAB-Q questionnaire [ Time Frame: after 1year of treatment ] [ Designated as safety issue: No ]
Same as current
 
Detrol LA vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms
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

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.

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

 
Interventional
Treatment, Randomized, Double Blind (Caregiver, Investigator), Active Control, Crossover Assignment
Overactive Bladder
  • Drug: tolterodine LA
  • Drug: Estrace Vaginal Cream
  • Active Comparator: Women who also have some stress urinary symptoms as reported on the MESA questionnaire
  • Active Comparator: Women with only urge urinary symptoms
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
60
May 2010
November 2009   (final data collection date for primary outcome measure)

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
Female
40 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00465894
Holly E. Richter, PH.D., M.D., Professor, Depart. of OB/GYN; Womens Pelvic Medicine & Reconstructive Surgery, University of Alabama at Birmingham
F061208008, IIR - DRIVE
University of Alabama at Birmingham
Pfizer
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
University of Alabama at Birmingham
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP