Phase 4
N=547
Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder.
Detrusor Overactivity · Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT01093534 ↗Enrolled (actual)
547
Serious AEs
1.1%
Results posted
Apr 2014
Primary outcome: Primary: Change From Baseline to Week 12 in Bladder Wall Thickness — 0.00; -0.29; -0.18; -0.24 mm — p=0.095
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo (Drug); solifenacin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Astellas Pharma Inc
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in Bladder Wall Thickness |
0.00; -0.29; -0.18; -0.24 | 0.095 |
| PRIMARY Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12 |
30.359; 31.855; 38.917; 35.325 | 0.250 |
| SECONDARY Total Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12 |
26.564; 30.135; 34.199; 32.143 | — |
| SECONDARY Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) at Week 12 |
116.9; 158.1; 160.4; 159.2 | — |
| SECONDARY Change From Baseline to Week 6 and Week 12 in Bladder Wall Thickness |
-0.01; -0.04; -0.14; -0.09; 0.02; -0.26 | — |
| SECONDARY Change From Baseline to Week 6 and Week 12 in Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine |
-4.638; 4.650; 4.309; 4.481; -1.318; 0.801 | — |
| SECONDARY Change From Baseline to Week 12 in Mean Number of Events (Micturitions Plus Incontinence Episodes) Per 24 Hours |
-1.40; -2.44; -1.80; -2.13 | — |
| SECONDARY Change From Baseline to Week 12 in Mean Number of Urgency Events Per 24 Hours |
-1.58; -2.22; -1.88; -2.06 | — |
| SECONDARY Change From Baseline to Week 12 in Mean Number of Micturitions Per 24 Hours |
-1.18; -1.80; -1.28; -1.55 | — |
| SECONDARY Change From Baseline to Week 12 in Mean Number of Urgency Micturitions Per 24 Hours |
-1.35; -1.77; -1.60; -1.69 | — |
| SECONDARY Change From Baseline to Week 12 in Mean Number of Incontinence Episodes Per 24 Hours |
-0.60; -1.49; -1.04; -1.24 | — |
| SECONDARY Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 3 or 4 Per 24 Hours |
-0.71; -1.32; -0.90; -1.09 | — |
| SECONDARY Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 4 Per 24 Hours |
-0.70; -0.96; -0.70; -0.82 | — |
| SECONDARY Change From Baseline to Week 12 in Mean Level of Urgency |
-0.15; -0.23; -0.24; -0.23 | — |
| SECONDARY Change From Baseline to Week 12 in Total Urgency Score |
-13.61; -22.39; -16.91; -19.81 | — |
| SECONDARY Change From Baseline in Patient Perception of Bladder Condition (PPBC) |
-0.7; -1.3; -1.3; -1.3 | — |
| SECONDARY Change From Baseline in Patient Assessment of Urgency Bother |
-12.60; -27.70; -28.90; -28.20 | — |
| SECONDARY Change From Baseline in Patient Assessment of Treatment Satisfaction |
18.90; 24.90; 31.90; 28.20 | — |
| SECONDARY Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D |
6.7; 10.3; 9.6; 10.0; 10.3; 7.1 | — |
| SECONDARY Change From Baseline in EuroQoL 5-Dimension Questionnaire Visual Analog Scale |
3.60; 4.80; 5.10; 4.90 | — |
| SECONDARY Change From Baseline in Symptom Bother Score |
-14.90; -22.32; -22.91; -22.60 | — |
| SECONDARY Change From Baseline in Health-Related Quality of Life (HRQL) |
11.72; 17.25; 17.69; 17.46; 12.40; 18.26 | — |
| SECONDARY Change From Baseline to Week 12 in Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) |
-27.4; 31.1; -88.1; -27.8 | — |
| SECONDARY Change From Baseline to Week 12 in Total Urinary Nerve Growth Factor Normalized by Urine Creatinine |
-0.962; 2.758; 3.858; 3.302 | — |
| SECONDARY Percentage of Participants With Improvement or Deterioration in Patient Perception of Bladder Condition (PPBC) |
15.4; 6.4; 5.2; 5.9; 34.9; 21.6 | — |
Summary
The purpose is to see if solifenacin has any effect on bladder wall thickness and urine inflammatory marker measurements after 12 weeks of treatment.
Eligibility Criteria
Inclusion Criteria
- Symptoms of overactive bladder (OAB), including urinary frequency, urgency or urge incontinence, for greater than or equal to 3 months
- Urodynamic diagnosis of detrusor overactivity (DO)
- Either naïve to anti-muscarinic treatment (i.e. no prior history of use of anti-muscarinic agents) or 6-months anti-muscarinic treatment free (i.e. have had no anti-muscarinic treatment within 6 months) prior to the screening visit
- Bladder post-void residual volume of less than 30 ml
- Available to complete the study
Exclusion Criteria
- History of stress urinary incontinence, urethral sphincter incompetence or neurogenic detrusor overactivity
- History, signs or symptoms suggestive of urinary tract infection (confirmed by positive urine analysis), obstruction or urogenital pro-lapse (greater than grade II)
- History of urinary tract operation within 6 months prior to screening
- Indwelling catheter or permanent catheter fitted
- History of pelvic area radiotherapy treatment
- Uncontrolled diabetes mellitus
- History of fibromyalgia
- Post-partum or breast-feeding within 3 months prior to screening visit
- Either pregnant or intends to become pregnant during the study or sexually active, of childbearing potential and is unwilling to utilize a reliable method of birth control (note: reliable methods are contraceptive pills of combination type, hormonal implants or injectable contraceptives)
- Positive pre-study hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus (HIV) result at time of screening
- History of drug and / or alcohol abuse at time of screening
- History of urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow angle glaucoma or shallow anterior chamber or deemed to be at risk for these conditions
- Undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment or who are on treatment with a potent cytochrome p450 (CYP) 3A4 inhibitor, e.g. Ketoconazole
- Currently dosing with medication(s) intended to treat overactive bladder symptoms or has a history of non-drug treatment, such as electrical therapy, magnetic field stimulation, pelvic floor treatment or bladder training intended to treat overactive bladder symptoms within 6 months prior to screening, as described in the list of prohibited medications
- Currently receiving or has a history of treatment with alpha blockers, botulinum toxin (cosmetic use is acceptable), resiniferatoxin or pelvic floor muscle relaxants within 9 months prior to screening
- Participated in any clinical study less than or equal to 3 months prior to screening
Data sourced from ClinicalTrials.gov (NCT01093534). 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.