Trial Outcomes & Findings for A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause. (NCT NCT00323635)

NCT ID: NCT00323635

Last Updated: 2018-03-29

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

2 months

Results posted on

2018-03-29

Participant Flow

Women 45 to 65 years old were mailed post-cards with the study telephone number and e-mail address. Subjects were assessed for eligibility. The PI determined eligibility based on the study criteria. Eligible subjects were informed about the study requirements, risks and benefits, and then required to read and sign a consent form.

Placebo responders were excluded after one week.

Participant milestones

Participant milestones
Measure	Tolterodine Tolterodine 4 mg q.d. X 8 weeks	Placebo A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
Overall Study STARTED	10	9
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tolterodine n=10 Participants Tolterodine 4 mg q.d. X 8 weeks	Placebo n=9 Participants A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	52 years STANDARD_DEVIATION 5.2 • n=5 Participants	53 years STANDARD_DEVIATION 5.2 • n=7 Participants	52 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Population: No data collected or analyzed for the outcome measures.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

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

Population: No data collected or analyzed for the outcome measures.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Duration of Study

Population: No data collected or analyzed for the outcome measures.

Number

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Duration of study

Population: No data collected or analyzed for the outcome measures.

4-grade scale

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: No data collected or analyzed for the outcome measures.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: No data collected or analyzed for the outcome measures.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 months

Population: No data collected or analyzed for the outcome measures.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Two 20-minute sessions during 2 months

Population: No data collected or analyzed for the outcome measures.

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline and 8 weeks later

Population: No data collected or analyzed for the outcome measures.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of Study

Population: No data collected or analyzed for the outcome measures.

Yes/No

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of Study

Population: No data collected or analyzed for the outcome measures.

Pads used

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Two weeks

Population: No data collected or analyzed for the outcome measures.

Wrist actigraphy measures of total daytime and nighttime activity scored by standardized Actiwatch measures of sleep and sake.

Outcome measures

Outcome data not reported

Adverse Events

Tolterodine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tolterodine n=10 participants at risk Tolterodine 4 mg q.d. X 8 weeks	Placebo n=9 participants at risk A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/10 • 9 weeks Only serious adverse effects were collected	11.1% 1/9 • Number of events 1 • 9 weeks Only serious adverse effects were collected

Other adverse events

Adverse event data not reported

Additional Information

Quentin Regestein

Brigham and Women's Hospital

Phone: 617-732-4497

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place