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Urinary IncontinencePhase 4NCT00323635

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

A Phase 4 study testing tolterodine in people with Urinary Incontinence, run by Brigham and Women's Hospital at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 45 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Urinary Incontinence
What is being tested?
tolterodine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
19 participants
Where
2 sitesUnited States
Study dates
Apr 2006to Jan 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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 exogenous hormones including soy isoflavones or soybean-based shakes, or nutritional supplements that potentially reduce hot flashes.
  • Have discontinued all hormone treatments, systemic, topical, or vaginal, at least 60 days before admission and throughout participation in the study.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.
  • -

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02120

Other trials in United States

About this study

Official title: A Parallel, Double-blind Comparison of Tolterodine vs. Placebo Treatments for Nocturia in Postmenopausal Women.

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.

Read the 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.

Being tested
tolterodine
Keywords
nocturia, urinary incontinence, overactive bladder, tolterodine, sleep, sleep disorder, menopause, midlife women, psychological tests
Medical subject headings
Urinary Incontinence, Nocturia, Urinary Bladder, Overactive, Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tolterodineDrug

    Also called Detrol

    tablet, 4 mg, daily, 1 month

Study groups in NCT00323635
Study groupRoleWhat they receive
TolterodineExperimentalTolterodine 4 mg q.d. X 8 weeks
Receives: Drug: tolterodine
PlaceboPlacebo comparatorA capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
Receives: Drug: tolterodine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nocturnal Urinary Frequency, Recorded on an Event/Symptom Chart;

    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.

    Measured: 2 months

  2. Urgency

    Level of urgency for 7 days, graded 1 to 4,

    Measured: Beginning after the first void on the Friday morning of week 7 and week 13 of their participation;

  3. Number of Incontinence Episodes;

    Number

    Measured: Duration of Study

  4. Relationship of Incontinence to Urge or Stress

    4-grade scale

    Measured: Duration of study

Secondary outcomes (7)

  1. Psychological Self-reports, Scores on Anxiety and Depression Rating Scales;

    State and Trait scores on Spielberger State-Trait Anxiety Inventory; The score measured by the Zung Self-Rating Depression Inventory.

    Measured: 2 weeks

  2. Quality of Life, Scores on the Women's Health Questionnaire.

    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.

    Measured: 2 weeks

  3. Sleep Quality

    Measured: 2 months

  4. Cognitive Function

    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)

    Measured: Two 20-minute sessions during 2 months

  5. Hyperarousal

    Score on 26-item self-report Hyperarousal Scale that indicates proportion of attention allocated to visceral-somatic information vs. external sensory data.

    Measured: At baseline and 8 weeks later

  6. Whether She Used Any Pads.

    Yes/No

    Measured: Duration of Study

  7. Pads Used

    Pads used

    Measured: Duration of Study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionJan 2010
  4. Study completionJan 2011

Why it stopped: New department chairman instructed PI to discontinue study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00323635
Sponsor's protocol ID
2005-P-000960
Status last verified
Mar 2018
First submitted
5 May 2006
Last updated
29 Mar 2018
Data monitoring committee
Yes

Publications

  • Roehrs T, Merlotti L, Petrucelli N, Stepanski E, Roth T. Experimental sleep fragmentation. Sleep. 1994 Aug;17(5):438-43. doi: 10.1093/sleep/17.5.438.

    PubMed 7991955

  • Shaver JL, Paulsen VM. Sleep, psychological distress, and somatic symptoms in perimenopausal women. Fam Pract Res J. 1993 Dec;13(4):373-84.

    PubMed 8285088

  • Ancoli-Israel S, Cole R, Alessi C, Chambers M, Moorcroft W, Pollak CP. The role of actigraphy in the study of sleep and circadian rhythms. Sleep. 2003 May 1;26(3):342-92. doi: 10.1093/sleep/26.3.342.

    PubMed 12749557

  • Brooks JO 3rd, Friedman L, Bliwise DL, Yesavage JA. Use of the wrist actigraph to study insomnia in older adults. Sleep. 1993 Feb;16(2):151-5. doi: 10.1093/sleep/16.2.151.

    PubMed 8446835

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing tolterodine in people with Urinary Incontinence, run by Brigham and Women's Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nocturnal Urinary Frequency, Recorded on an Event/Symptom Chart; (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00323635, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.

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