Trial · NCT01729819
Interventional Clinical Trial in Patients in Overactive Bladder With Nocturia in Women
NCT01729819, Phase 2, Completed, Ferring Pharmaceuticals; results first posted 2018-08-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Interventional Clinical Trial in Patients in Overactive Bladder With Nocturia in Women. Trials, record NCT01729819. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01729819
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Interventional Clinical Trial in Patients in Overactive Bladder With Nocturia in Women
- NCT number
- NCT01729819
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 106 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Overactive Bladder
- Interventions
- Tolterodine tartrate extended release capsules, Desmopressin orally disintegrating tablets, Placebo orally disintegrating tablets
- First posted
- 2012-11-20
- Last updated
- 2018-09-12
- Results first posted
- 2018-08-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Number of Nocturnal Voids From Baseline | 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. |
| Secondary | Change in Mean Time to First Nocturnal Void From Baseline | 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. |
| Secondary | Change in Mean Nocturnal Urine Volume From Baseline | 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. |
| Secondary | Responder Status | 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. |
| Secondary | Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment | 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. |
| Secondary | Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean Number of Nocturnal Voids From Baseline | Baseline to 3 months of treatment | The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group). | Voids | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Mean Time to First Nocturnal Void From Baseline | Baseline to 3 months of treatment | The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group). | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Mean Nocturnal Urine Volume From Baseline | Baseline to 3 months of treatment | The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group). | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Responder Status | Baseline to 3 months of treatment | The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group). | Proportion of responders | NUMBER |
| SECONDARY | Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment | Baseline to 3 months of treatment | The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group). | Voids | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline | Baseline to 3 months of treatment | The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group). | Score on scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Number of Nocturnal Voids From Baseline | Combination | -1.63 | 95% Confidence Interval -1.94 to -1.32 | Voids | |
| Change in Mean Number of Nocturnal Voids From Baseline | Tolterodine | -1.29 | 95% Confidence Interval -1.57 to -1.00 | Voids | |
| Change in Mean Time to First Nocturnal Void From Baseline | Combination | 118.19 | 95% Confidence Interval 88.53 to 147.85 | Minutes | |
| Change in Mean Time to First Nocturnal Void From Baseline | Tolterodine | 100.19 | 95% Confidence Interval 72.67 to 127.72 | Minutes | |
| Change in Mean Nocturnal Urine Volume From Baseline | Combination | -156.6 | 95% Confidence Interval -212.88 to -100.37 | mL | |
| Change in Mean Nocturnal Urine Volume From Baseline | Tolterodine | -92.46 | 95% Confidence Interval -145.27 to -39.66 | mL | |
| Responder Status | Combination | 0.40 | Proportion of responders | ||
| Responder Status | Tolterodine | 0.29 | Proportion of responders | ||
| Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment | Treatment Difference (Combination-tolterodine) | Month 1 | -0.19 | 95% Confidence Interval -0.68 to 0.30 | Voids |
| Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment | Treatment Difference (Combination-tolterodine) | Month 2 | -0.44 | 95% Confidence Interval -0.95 to 0.06 | Voids |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combination | 49 | |
| Overall Study | STARTED | Tolterodine | 57 | |
| Overall Study | COMPLETED | Combination | 43 | |
| Overall Study | COMPLETED | Tolterodine | 50 | |
| Overall Study | NOT COMPLETED | Combination | 6 | |
| Overall Study | NOT COMPLETED | Tolterodine | 7 |
Source ClinicalTrials.gov
Adverse events4
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 |
|---|---|---|---|---|---|---|
| other | Dry mouth | Gastrointestinal disorders | Combination | 1 | 48 | 1 |
| other | Dry mouth | Gastrointestinal disorders | Tolterodine | 6 | 55 | 6 |
| other | Headache | Nervous system disorders | Combination | 2 | 48 | 2 |
| other | Headache | Nervous system disorders | Tolterodine | 5 | 55 | 5 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination | 0 | 48 |
| Total, all-cause mortality | Tolterodine | 0 | 55 |
| Total, other adverse events | Combination | 3 | 48 |
| Total, other adverse events | Tolterodine | 9 | 55 |
| Total, serious adverse events | Combination | 0 | 48 |
| Total, serious adverse events | Tolterodine | 0 | 55 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Combination vs Tolterodine: deaths from any cause | Trial comparisons |
| Combination vs Tolterodine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT01729819
GET https://conductscience.org/api/trials/v1/NCT01729819/registered