Detrol LA vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms - Full Text View

Sponsor:	University of Alabama at Birmingham
Collaborator:	Pfizer
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00465894

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:	Treatment, Randomized, Double Blind (Caregiver, Investigator), Active Control, Crossover Assignment
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:

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Tolterodine Tolterodine tartrate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	60
Study Start Date:	April 2007
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator 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

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

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

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233

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:	University of Alabama at Birmingham ( Holly E. Richter, PH.D., M.D., Professor, Depart. of OB/GYN; Womens Pelvic Medicine & Reconstructive Surgery )
Study ID Numbers:	F061208008, IIR - DRIVE
Study First Received:	April 23, 2007
Last Updated:	September 3, 2009
ClinicalTrials.gov Identifier:	NCT00465894 History of Changes
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
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Contraceptive Agents
Estradiol valerate
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Estradiol 17 beta-cypionate
Reproductive Control Agents
Cholinergic Agents
Hormones

Signs and Symptoms
Urologic Diseases
Estradiol 3-benzoate
Therapeutic Uses
Polyestradiol phosphate
Estrogens
Urinary Bladder Diseases
Estradiol
Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Tolterodine

ClinicalTrials.gov processed this record on November 09, 2009