Trial · NCT00601484
Registered outcomes46
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 46
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average Daily Pain Score at Week 6 | Baseline, Week 6 | Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Here, 'Number analyzed' = participants with available data for each specified category. |
| Secondary | Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16 | Baseline, Week 2, 4, 10, 16 | Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point NRS ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. |
| Secondary | Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point NRS ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. |
| Secondary | Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder. Each question in the ICSI was rated on a 0 (no symptoms) to 5 (severe symptoms) scale, with higher scores indicating greater symptom severity. The sum of the individual question ratings was the total score for the ICSI. Total score ranged from 0 (no symptoms) to 20 (severe symptoms), with higher score indicating greater symptom severity. |
| Secondary | Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder. Each question in the ICSI was rated on a 0 (no symptoms) to 5 (severe symptoms) scale, with higher scores indicating greater symptom severity. The sum of the individual question ratings was the total score for the ICSI. Total score ranged from 0 (no symptoms) to 20 (severe symptoms), with higher score indicating greater symptom severity. |
| Secondary | Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The micturition frequency per 24 hours was calculated from the sum of voluntary voids divided by the number of diary days over which they were collected. |
| Secondary | Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The micturition frequency per 24 hours was calculated from the sum of voluntary voids divided by the number of diary days over which they were collected. |
| Secondary | Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The nocturnal frequency per night was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected. |
| Secondary | Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The nocturnal frequency per night was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline. |
| Secondary | Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The incontinence episode frequency per 24 hours was calculated as the sum of any incontinence episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded. |
| Secondary | Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The incontinence episode frequency per 24 hours was calculated as the sum of any incontinence episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline. |
| Secondary | Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | Mean voided volume per micturition was calculated as the total urine volume voided (resulting from a toilet \[voluntary\] void) during the diary period when this was measured, divided by the number of toilet voids over which this occurred. |
| Secondary | Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | Mean voided volume per micturition was calculated as the total urine volume voided (resulting from a toilet \[voluntary\] void) during the diary period when this was measured, divided by the number of toilet voids over which this occurred. |
| Secondary | Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | Mean interstitial cystitis pain severity per urinary event (toilet void, accidental urine loss, urgency episode) was calculated as the mean of all pain severities recorded during the diary period when these events were measured. For each urinary event (toilet void, accidental urine loss, urgency episode), participants marked their associated level of pain intensity (or pressure, aching, burning, discomfort) using an 11-point NRS ranging from 0 denoting none (no pain), and 10 denoting worst (pain as bad as you can imagine), where higher scores indicated higher pain. Total mean interstitial cystitis pain severity per urinary event score ranged from 0 (no pain) to 10 worst (pain as bad as you can imagine), where higher scores indicated more pain. |
| Secondary | Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | Mean interstitial cystitis pain severity per urinary event (toilet void, accidental urine loss, urgency episode) was calculated as the mean of all pain severities recorded during the diary period when these events were measured. For each urinary event (toilet void, accidental urine loss, urgency episode), participants marked their associated level of pain intensity (or pressure, aching, burning, discomfort) using an 11-point NRS ranging from 0 denoting none (no pain), and 10 denoting worst (pain as bad as you can imagine), where higher scores indicated higher pain. Total mean interstitial cystitis pain severity per urinary event score ranged from 0 (no pain) to 10 worst (pain as bad as you can imagine), where higher scores indicated more pain. |
| Secondary | Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The urinary urgency episode per 24 hours was calculated as the sum of any urgency episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded. |
| Secondary | Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The urinary urgency episode per 24 hours was calculated as the sum of any urgency episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline. |
| Secondary | Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | Average sleep disturbance score was calculated from the sleep disturbance experienced over the previous night. The average sleep disturbance score per night was determined from calculating the mean of all sleep disturbance scores in the 7 days prior to each assessment time point. Participants answered the following question: "Over the past 24 hours, how much did the symptoms that you associate with your interstitial cystitis disturb your sleep?" Participants responded on a 5-point scale ranging from 0 (not at all) to 4 (extremely); where higher scores indicated more sleep disturbance. |
| Secondary | Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | Average sleep disturbance score was calculated from the sleep disturbance experienced over the previous night. The average sleep disturbance score per night was determined from calculating the mean of all sleep disturbance scores in the 7 days prior to each assessment time point. Participants answered the following question: "Over the past 24 hours, how much did the symptoms that you associate with your interstitial cystitis disturb your sleep?" Participants responded on a 5-point scale ranging from 0 (not at all) to 4 (extremely); where higher scores indicated more sleep disturbance. Percent change from baseline was calculated for participants who reported greater than 0 score at baseline. |
| Secondary | Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The average pain score associated with sexual activity was determined from calculating the mean of sexual activity scores of 7 days prior to each assessment time point. Participants answered the following question: "Over the past 24 hours, how much pain did you experience during or after sexual activity?" Participants responded on a 5-point scale ranging from 0 (no pain) to 4 (extremely painful); where higher scores indicated higher pain. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT00601484/registered