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Trial · NCT00323635

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNocturnal 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.
PrimaryUrgencyBeginning 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,
PrimaryNumber of Incontinence Episodes;Duration of StudyNumber
PrimaryRelationship of Incontinence to Urge or StressDuration of study4-grade scale
SecondaryPsychological Self-reports, Scores on Anxiety and Depression Rating Scales;2 weeksState and Trait scores on Spielberger State-Trait Anxiety Inventory; The score measured by the Zung Self-Rating Depression Inventory.
SecondaryQuality 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.
SecondarySleep Quality2 months
SecondaryCognitive FunctionTwo 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)
SecondaryHyperarousalAt baseline and 8 weeks laterScore on 26-item self-report Hyperarousal Scale that indicates proportion of attention allocated to visceral-somatic information vs. external sensory data.
SecondaryWhether She Used Any Pads.Duration of StudyYes/No
SecondaryPads UsedDuration of StudyPads used
OtherSleep / Wake PatternTwo weeksWrist actigraphy measures of total daytime and nighttime activity scored by standardized Actiwatch measures of sleep and sake.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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