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

The University of Alabama at Birmingham

Status: Completed

Conditions: Overactive Bladder

Treatments: Drug: Intra Vaginal Estradiol Cream; Drug: Extended Release Tolterodine LA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00465894

IIR - DRIVE

F061208008

Details and patient eligibility

About

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.

Full 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

Enrollment: 58 patients

Sex: Female

Ages: 40 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Extended Release Tolterodine LA

Active Comparator group

Description:

An anti-muscarinic drug that is used for symptomatic treatment of urinary incontinence.

Treatment:

Drug: Extended Release Tolterodine LA

Intra Vaginal Estradiol Cream

Active Comparator group

Description:

For topical application to the vaginal area to treat symptoms of urgency or irritation with urination.

Treatment:

Drug: Intra Vaginal Estradiol Cream