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Therapeutic Areas: Obstetrics/Gynecology | Endocrinology
Disease Category: Menopause
Trial Information
A Cross-Over, Double Blind Comparison of Tolterodine vs. Placebo Treatments for Nocturia (frequent night time trips to the bathroom) in Perimenopausal and Post Menopausal Women
The purpose of the research study is to evaluate the effects of tolterodine on nocturia and associated sleep disturbance. Tolterodine is FDA approved for overactive bladder.
Nocturia is a condition involving frequent night-time urination. Participants will receive tolterodine or placebo (inactive medication) tablet orally for 8 weeks and then tolterodine or placebo for the next 8 weeks, whichever they did not already receive.
Approximately 61 women, ages 45 to 64, who experience nocutria, will take part in this study. We hope to have 49 subjects complete the study. Subjects will be asked to participate in this study for 16 weeks and to come to the hospital for 3 visits.
Eligibility Criteria:
1.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 related to overactive bladder, stress incontinence or polyuria (release of abnormally large amounts of urine each day.)
4.Free of medical illness, as evidenced in care provider’s physical examination.
Laurel Dantas
Massachusetts General Hospital
55 Fruit Street
Boston, MA 02114
Phone: 617-525-7793
EMail: RCNet@partners.org
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If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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