Trial · NCT00323635
A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.
NCT00323635, Phase 4, Terminated, Brigham and Women's Hospital; results first posted 2014-12-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause. Trials, record NCT00323635. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00323635
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.
- NCT number
- NCT00323635
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 19 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Urinary Incontinence
- Interventions
- tolterodine
- First posted
- 2006-05-09
- Last updated
- 2018-03-29
- Results first posted
- 2014-12-04
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Nocturnal Urinary Frequency, Recorded on an Event/Symptom Chart; | 2 months | 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. |
| Primary | Urgency | Beginning after the first void on the Friday morning of week 7 and week 13 of their participation; | Level of urgency for 7 days, graded 1 to 4, |
| Primary | Number of Incontinence Episodes; | Duration of Study | Number |
| Primary | Relationship of Incontinence to Urge or Stress | Duration of study | 4-grade scale |
| Secondary | Psychological Self-reports, Scores on Anxiety and Depression Rating Scales; | 2 weeks | State and Trait scores on Spielberger State-Trait Anxiety Inventory; The score measured by the Zung Self-Rating Depression Inventory. |
| Secondary | Quality of Life, Scores on the Women's Health Questionnaire. | 2 weeks | 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. |
| Secondary | Sleep Quality | 2 months | |
| Secondary | Cognitive Function | Two 20-minute sessions during 2 months | 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) |
| Secondary | Hyperarousal | At baseline and 8 weeks later | Score on 26-item self-report Hyperarousal Scale that indicates proportion of attention allocated to visceral-somatic information vs. external sensory data. |
| Secondary | Whether She Used Any Pads. | Duration of Study | Yes/No |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Nocturnal Urinary Frequency, Recorded on an Event/Symptom Chart; | 2 months | No data collected or analyzed for the outcome measures. | ||
| PRIMARY | Urgency | Beginning after the first void on the Friday morning of week 7 and week 13 of their participation; | No data collected or analyzed for the outcome measures. | ||
| PRIMARY | Number of Incontinence Episodes; | Duration of Study | No data collected or analyzed for the outcome measures. | ||
| PRIMARY | Relationship of Incontinence to Urge or Stress | Duration of study | No data collected or analyzed for the outcome measures. | ||
| SECONDARY | Psychological Self-reports, Scores on Anxiety and Depression Rating Scales; | 2 weeks | No data collected or analyzed for the outcome measures. | ||
| SECONDARY | Quality of Life, Scores on the Women's Health Questionnaire. | 2 weeks | No data collected or analyzed for the outcome measures. | ||
| SECONDARY | Sleep Quality | 2 months | No data collected or analyzed for the outcome measures. | ||
| SECONDARY | Cognitive Function | Two 20-minute sessions during 2 months | No data collected or analyzed for the outcome measures. | ||
| SECONDARY | Hyperarousal | At baseline and 8 weeks later | No data collected or analyzed for the outcome measures. | ||
| SECONDARY | Whether She Used Any Pads. | Duration of Study | No data collected or analyzed for the outcome measures. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tolterodine | 10 | |
| Overall Study | STARTED | Placebo | 9 | |
| Overall Study | COMPLETED | Tolterodine | 10 | |
| Overall Study | COMPLETED | Placebo | 9 | |
| Overall Study | NOT COMPLETED | Tolterodine | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Pneumonia | Respiratory, thoracic and mediastinal disorders | Tolterodine | 0 | 10 | 0 |
| serious | Pneumonia | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 9 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tolterodine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Tolterodine | 0 | 0 |
| Total, other adverse events | Placebo | 0 | 0 |
| Total, serious adverse events | Tolterodine | 0 | 10 |
| Total, serious adverse events | Placebo | 1 | 9 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tolterodine vs Placebo: serious adverse events |
Source Trial comparisons
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Stroop Color-Word Test | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00323635
GET https://conductscience.org/api/trials/v1/NCT00323635/registered