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

NCT00465894 | Completed Results

• 2 other identifiers: F061208008IIR - DRIVE
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overactive Bladder

Keywords

overactive bladder; urge leakage; nightime urination; incontinence; urinary frequency

Outcome Measures

Primary Outcomes (1)

• Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score

  The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.

  From baseline through 12 Weeks of Intervention

Secondary Outcomes (12)

• Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL)

  From baseline through 12 Weeks of Intervention

• Evaluate Subjective Patient Change in Irritative Urinary Symptoms

  From baseline through 12 Weeks of Intervention

• Subjective Patient Change in Irritative Urinary Symptoms

  From baseline through 12 Weeks of Intervention

• Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary

  From baseline through 12 weeks of Intervention

• Subjective Patient Change in Irritative Urinary Symptoms

  Baseline to 24 weeks

Study Arms (2)

Extended Release Tolterodine LA

ACTIVE COMPARATOR

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

Drug: Extended Release Tolterodine LA

Intra Vaginal Estradiol Cream

ACTIVE COMPARATOR

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

Drug: Intra Vaginal Estradiol Cream

Interventions

Extended Release Tolterodine LA 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

Also known as: Detrol

Extended Release Tolterodine LA

Intra Vaginal Estradiol Cream 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.

Also known as: Estrace, Premarin vaginal cream

Intra Vaginal Estradiol Cream

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Pfizer: collaborator

Related Publications (1)

• 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.

  PMID: 26945271 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Tolterodine Tartrate; Estradiol

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Holly E. Richter
• Organization: University of Alabama at Birmingham

hrichter@uabmc.edu

205-934-1704

Study Officials

• Kimberly Gerten, M.D.

  Park Nicollette, St. Louis, Minnesota

  PRINCIPAL INVESTIGATOR

• Holly E. Richter, Ph.D., M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 25, 2007
• Study Start: April 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2011
• Last Updated: November 1, 2018
• Results First Posted: October 23, 2012

Record last verified: 2018-10