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

This study has been terminated.
(New department chairman instructed PI to discontinue study.)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Quentin Rodney Regestein, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00323635
First received: May 5, 2006
Last updated: February 27, 2013
Last verified: February 2013
  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 4

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:


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 ]
    Subjects note: 1. Number of nocturnal and diurnal voids; 2) level of urgency for 7 days, graded 1 to 4, beginning after the first void on the Friday morning of week 7 and week 13 of their participation; 3) Number of incontinence episodes; 4) Relationship of incontinence to urge or stress (4 grade scale); 4) Whether she used any pads.


Secondary Outcome Measures:
  • Psychological self-reports, scores on anxiety and depression rating scales; [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    State and Trait scores on Spielberger State-Trait Anxiety Inventory; The score measured by the Zung Self-Rating Depression Inventory.

  • Quality of life, scores on the Women's Health Questionnaire. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Self-reported vasomotor symptoms, other somatic symptoms, anxiety, depression, sleep and cognitive symptoms (memory, concentration and clumsiness problems), measured as category scores. Subjective sleep onset and total sleep times measured as 7-day averaged minutes.

  • Sleep quality [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Cognitive function [ Time Frame: Two 20-minute sessions during 2 months ] [ Designated as safety issue: No ]
    Motor speed (number of finger taps in 30 seconds); Continuous Performance (mean response time elicited by appearance of target alphabet letter presented in a series of letters on a monitor screen for 1 minute); Color-Word Stroop Test (response times to stimuli with congruent word and color)

  • Hyperarousal [ Time Frame: At baseline and 8 weeks later ] [ Designated as safety issue: No ]
    Score on 26-item self-report Hyperarousal Scale that indicates proportion of attention allocated to visceral-somatic information vs. external sensory data.


Other Outcome Measures:
  • Sleep / Wake Pattern [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    Wrist actigraphy measures of total daytime and nighttime activity scored by standardized Actiwatch measures of sleep and sake.


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: Tolterodine
Tolterodine 4 mg q.d. X 8 weeks
Drug: tolterodine
tablet, 4 mg, daily, 1 month
Other Name: Detrol
Placebo Comparator: Placebo
A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine

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:

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

Exclusion Criteria:

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

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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 27, 2013
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
Lower Urinary Tract Symptoms
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
Urological Agents
Therapeutic Uses
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 18, 2014