Change in Mean Number of Nocturnal Voids From Baseline
| Group | Value (Voids) |
|---|---|
| Combination | -1.63 |
| Tolterodine | -1.29 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Interventional Clinical Trial in Patients in Overactive Bladder With Nocturia in Women
NCT01729819Jan 2013 to Nov 2014
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of the trial is to investigate the efficacy of combining tolterodine and desmopressin compared with tolterodine monotherapy in the treatment of women with overactive bladder with nocturia in terms of reduction of nocturnal voids during 3 months of treatment
Experimental
Combination
Tolterodine tartrate extended release capsules + Desmopressin orally disintegrating tablets
Active comparator
Tolterodine
Tolterodine tartrate extended release capsules + Placebo orally disintegrating tablets
Outcomes the sponsor listed as primary.
Change in Mean Number of Nocturnal Voids From Baseline
Time frame · Baseline to 3 months of treatment
A nocturnal void was defined as a void occurring at least 5 minutes after going to bed, but before getting up the next morning. The mean estimate was the average over 3 consecutive 24-hour periods prior to the respective visit as captured in the voiding and sleep diary.
Change in Mean Time to First Nocturnal Void From Baseline
Time frame · Baseline to 3 months of treatment
The time to first nocturnal void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in the case there is no nocturnal void. The time to first void was calculated as the average over three consecutive 24-hour periods prior to the respective visits.
Change in Mean Nocturnal Urine Volume From Baseline
Time frame · Baseline to 3 months of treatment
The mean nocturnal urine volume was derived from the three-day urine volume diary. The nocturnal volume was defined as the sum of the volumes for all nocturnal voids including the volume of the first morning void within 30 min of waking up in the morning.
Responder Status
Time frame · Baseline to 3 months of treatment
Responder status was defined as ≥33% decrease in the mean number of nocturnal void and at least one night with no voids out of the 3-day diary period.
Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment
Time frame · Baseline to 3 months of treatment
A nocturnal void was defined as a void occurring at least 5 minutes after going to bed, but before getting up the next morning. The mean estimate was the average over 3 consecutive 24-hour periods prior to the respective visit as captured in the voiding and sleep diary.
Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline
Time frame · Baseline to 3 months of treatment
An electronic diary was used in the trial to document the impact on sleep quality (sleep rating scales). The sleep rating scales included three questions that ranged from 0 (poor) to 10 (good). The average of each question for each visit was summarised and the change from baseline was analysed longitudinally during the three months of treatment.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Voids) |
|---|---|
| Combination | -1.63 |
| Tolterodine | -1.29 |
| Group | Value (Minutes) |
|---|---|
| Combination | 118.19 |
| Tolterodine | 100.19 |
| Group | Value (mL) |
|---|---|
| Combination | -156.6 |
| Tolterodine | -92.46 |
| Group | Value (Proportion of responders) |
|---|---|
| Combination | 0.40 |
| Tolterodine | 0.29 |
| Group | Value (Voids) |
|---|---|
| Treatment Difference (Combination-tolterodine) | -0.19 |
| Group | Value (Score on scale) |
|---|---|
| Combination | 1.76 |
| Tolterodine | 1.33 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| CombinationTolterodine tartrate extended release capsules + Desmopressin orally disintegrating tablets Tolterodine tartrate extended release capsules Desmopressin orally disintegrating tablets | 0 / 48 | 0 / 48 | 3 / 48 |
| TolterodineTolterodine tartrate extended release capsules + Placebo orally disintegrating tablets Tolterodine tartrate extended release capsules Placebo orally disintegrating tablets | 0 / 55 | 0 / 55 | 9 / 55 |
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