Phase 4
N=963
A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency
Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT00911937 ↗Enrolled (actual)
963
Serious AEs
1.5%
Results posted
Aug 2012
Primary outcome: Primary: Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours — 2.93; 2.91 episodes per 24 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fesoterodine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours |
2.93; 2.91 | — |
| PRIMARY Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12 |
-1.06; -1.29 | 0.0030 sig |
| SECONDARY Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 |
-0.70; -0.83 | 0.0772 |
| SECONDARY Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12 |
-24.1; -28.4; -36.2; -44.5 | 0.0001 sig |
| SECONDARY Number of Nocturnal Micturitions Per 24 Hours |
3.19; 3.15 | — |
| SECONDARY Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12 |
-0.48; -0.59; -0.84; -1.02 | 0.0827 |
| SECONDARY Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 |
-15.1; -18.9; -26.2; -32.2 | 0.0023 sig |
| SECONDARY Mean Number of Micturitions Per 24 Hours |
12.33; 12.30 | — |
| SECONDARY Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12 |
-0.90; -1.35; -1.86; -2.42 | 0.0026 sig |
| SECONDARY Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 |
-6.7; -10.3; -14.2; -18.7 | 0.0016 sig |
| SECONDARY Number of Micturition-related Urgency Episodes Per 24 Hours |
10.04; 9.84 | — |
| SECONDARY Change From Baseline in Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 |
-1.59; -2.18; -2.72; -3.50 | 0.0072 sig |
| SECONDARY Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 |
-14.9; -20.0; -25.7; -34.2 | 0.0041 sig |
| SECONDARY Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours |
2.23; 2.20 | — |
| SECONDARY Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 |
-0.76; -0.90; -1.08; -1.26 | 0.3954 |
| SECONDARY Percent Change From Baseline in of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 |
-34.2; -34.8; -58.2; -59.2 | — |
| SECONDARY Nocturnal Frequency-urgency Sum Rating Per 24 Hours |
10.91; 10.60 | — |
| SECONDARY Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12 |
-2.07; -2.46; -3.36; -4.08 | 0.1018 |
| SECONDARY Frequency-urgency Sum Rating Per 24 Hours |
39.54; 38.73 | — |
| SECONDARY Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12 |
-4.88; -6.44; -8.69; -11.12 | 0.0131 sig |
| SECONDARY Mean Voided Volume Per Nocturnal Micturition |
172.53; 173.14 | — |
| SECONDARY Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12 |
15.49; 16.81 | 0.8547 |
| SECONDARY Mean Voided Volume Per Micturition |
154.56; 158.38 | — |
| SECONDARY Change From Baseline in Mean Voided Volume Per Micturition at Week 12 |
5.51; 4.65 | 0.8396 |
| SECONDARY Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score |
50.46; 48.84 | — |
| SECONDARY Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12 |
NA; NA; -15.91; -20.28 | 0.0006 sig |
| SECONDARY Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) |
63.29; 64.30; 62.19; 62.26; 47.45; 49.65 | — |
| SECONDARY Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12 |
NA; NA; NA; NA; NA; NA | 0.0110 sig |
Summary
This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.
Eligibility Criteria
Inclusion Criteria
- Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)
- Mean number of micturition related urgency episodes >=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating >=3)
- Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in the bed time section of the bladder diary)
Exclusion Criteria
- A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
- Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.
Data sourced from ClinicalTrials.gov (NCT00911937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.