A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause. - Full Text View

Sponsor:	Brigham and Women's Hospital
Collaborator:	Pfizer
Information provided by (Responsible Party):	Quentin Rodney Regestein, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00323635

Purpose

This study is being done to compare frequency of urination during the night when women take tolterodine tablets vs. when they take placebo tablets.

We will also measure whether between these two treatment conditions there are any differences in women's sleep, mood and performance on cognitive tests.

Condition	Intervention	Phase
Urinary Incontinence	Drug: tolterodine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Cross-over, Double-blind Comparison of Tolterodine vs. Placebo Treatments for Nocturia in Postmenopausal Women.

Resource links provided by NLM:

MedlinePlus related topics: Menopause Urinary Incontinence Urine and Urination

Drug Information available for: Tolterodine Tolterodine tartrate

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Nocturnal urinary frequency, recorded on an event/symptom chart; [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Psychological self-reports, scores on anxiety and depression rating scales; [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Quality of life, scores on the Women's Health Questionnaire. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Sleep quality [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment:	19
Study Start Date:	April 2006
Study Completion Date:	January 2011
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: tolterodine tablet, 4 mg, daily, 1 month Other Name: Detrol

Detailed Description:

From midlife onwards, about half of women complain of poor sleep quality. One possible reason might be an increased frequency of need to urinate during the night. Women feel more frequent urges to urinate when structures that support the bladder become more lax. Tolterodine is a drug that can raise the threshold for volume of urine that accumulates in the bladder before the urge to urinate arises.

Many factors determine how people say they sleep, such as their sleep as recorded by sleep-measuring instruments, how closely they notice their night's sleep, whether they are generally prone to make positive or negative judgments or to have a lot or a few body symptoms.

In this study, women between ages 45 to 65 who are past the menopause and who are frequently bothered by the need to urinate during the night will take either tolterodine or placebo tablets for 8 weeks. During the last week they will record the hours they slept and the quality of their sleep each morning. They will wear a device on their wrist through the week that continuously records whether they are asleep or awake. During three nights of the week they will record the volume of urine whenever they urinate. At the end of the week they will complete questionnaires about their mood and take some computerized tests that measure their alertness. Thereafter they will repeat these procedures, taking the kind of tablets they did not take during the first 8-week treatment period.

We will compare the frequency of urination, sleep, mood as adjusted for the tendency to make positive or negative judgments and daytime attention level to find if any of these differ between the two treatment periods, and to explain differences between any differences that may be found.

Eligibility

Ages Eligible for Study:	45 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Post-menopausal women, age 45 to 65 years old.
No menses for at least 6 months before the study start.
Have at least 14 episodes of nocturia per week.
Have at least 4 hot flashes daily.
Overall good health, as evidenced by a letter from the primary care provider.
Agree not to use HRT including tolterodine shakes, or nutritional supplements that potentially reduce hot flashes.
Have discontinued all HRT, systemic, topical, or vaginal, at least 60 days before admission and throughout participation in the study.

Exclusion Criteria:

Use of anti-cholinergic, hypnotic or sedating drugs
Presence of urinary retention, gastric retention, chronic severe constipation,or narrow-angled glaucoma.
A urinary tract infection within a month of study start.
Undiagnosed abnormal vaginal bleeding.
Benign or malignant liver disease.
History or presence of chronic alcoholism or medication addiction within the past 5 yrs.
An acute systemic infection within seven days before the study start.
Concurrent participation in another clinical trial and/or receiving an experimental medication/device in the last 30 days before admission to the study.
History of shift work within the past 6 months.

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323635

Locations

United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02120
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Brigham and Women's Hospital

Pfizer

Investigators

Principal Investigator:

Quentin R Regestein, M.D.

Brigham and Women's Hospital

More Information

No publications provided

Responsible Party:	Quentin Rodney Regestein, MD, Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00323635 History of Changes
Other Study ID Numbers:	2005-P-000960
Study First Received:	May 5, 2006
Last Updated:	February 1, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

nocturia
urinary incontinence
overactive bladder
tolterodine
sleep

sleep disorder
menopause
midlife women
psychological tests

Additional relevant MeSH terms:

Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Tolterodine
Phenylpropanolamine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012