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

NCT ID: NCT00465894

Last Updated: 2018-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2011-12-31

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.

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

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Extended Release Tolterodine LA

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

Group Type: ACTIVE_COMPARATOR

Extended Release Tolterodine LA

Intervention Type: DRUG

Tolterodine LA 4 mg once daily for 52 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks

Intra Vaginal Estradiol Cream

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

Group Type: ACTIVE_COMPARATOR

Intra Vaginal Estradiol Cream

Intervention Type: DRUG

17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.

Interventions

Extended Release Tolterodine LA

Tolterodine LA 4 mg once daily for 52 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks

Intervention Type: DRUG

Intra Vaginal Estradiol Cream

17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.

Intervention Type: DRUG

Other Intervention Names

Detrol; Estrace; Premarin vaginal cream

Eligibility 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 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

David Rich Ellington

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimberly Gerten, M.D.

Role: PRINCIPAL_INVESTIGATOR

Park Nicollette, St. Louis, Minnesota

Holly E. Richter, Ph.D., M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

References

Ellington DR, Szychowski JM, Malek JM, Gerten KA, Burgio KL, Richter HE. Combined Tolterodine and Vaginal Estradiol Cream for Overactive Bladder Symptoms After Randomized Single-Therapy Treatment. Female Pelvic Med Reconstr Surg. 2016 Jul-Aug;22(4):254-60. doi: 10.1097/SPV.0000000000000256.

Reference Type: DERIVED

PMID: 26945271 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IIR - DRIVE

Identifier Type: -

Identifier Source: secondary_id

F061208008

Identifier Type: -

Identifier Source: org_study_id