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

NCT00323635 | Terminated Phase 4 Results DMC

• 1 other identifier: 2005-P-000960
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Urinary Incontinence

Keywords

nocturia; urinary incontinence; overactive bladder; tolterodine; sleep; sleep disorder; menopause; midlife women; psychological tests

Outcome Measures

Primary Outcomes (4)

• 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.

  2 months

• Urgency

  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;

• Number of Incontinence Episodes;

  Number

  Duration of Study

• Relationship of Incontinence to Urge or Stress

  4-grade scale

  Duration of study

Secondary Outcomes (7)

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

  2 weeks

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

  2 weeks

• Sleep Quality

  2 months

• Cognitive Function

  Two 20-minute sessions during 2 months

• Hyperarousal

  At baseline and 8 weeks later

Other Outcomes (1)

• Sleep / Wake Pattern

  Two weeks

Study Arms (2)

Tolterodine

EXPERIMENTAL

Tolterodine 4 mg q.d. X 8 weeks

Drug: tolterodine

Placebo

PLACEBO COMPARATOR

A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine

Drug: tolterodine

Interventions

tolterodine DRUG

tablet, 4 mg, daily, 1 month

Also known as: Detrol

Placebo; Tolterodine

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Pfizer: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Related Publications (4)

• 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.

  PMID: 7991955 BACKGROUND

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

  PMID: 8285088 BACKGROUND

• 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.

  PMID: 12749557 BACKGROUND

• 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.

  PMID: 8446835 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence; Nocturia; Urinary Bladder, Overactive; Sleep Wake Disorders

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urination Disorders; 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; Urinary Bladder Diseases; Nervous System Diseases; Neurologic Manifestations; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Results Point of Contact

• Title: Quentin Regestein
• Organization: Brigham and Women's Hospital

qregestein@partners.org

617-732-4497

Study Officials

• Quentin R Regestein, M.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 9, 2006
• Study Start: April 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2011
• Last Updated: March 29, 2018
• Results First Posted: December 4, 2014

Record last verified: 2018-03

Locations

US (2)