Clinical trial NCT01093534: Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder.
Official title: A Study to Evaluate the Overall Effect of Solifenacin 5mg and 10mg on Bladder Wall Thickness and Urinary Nerve Growth Factor in Female Subjects With Overactive Bladder and a Diagnosis of Detrusor Overactivity - A Double-blind, Randomised, Placebo-controlled, Parallel Group, Multi-centre Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Detrusor Overactivity
Overactive Bladder
Keywords: Vesicare
Solifenacin
Detrusor Overactivity
Urinary Nerve Growth Factor
Overactive Bladder
Bladder wall thickness
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-03-26
Enrollment: 547
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: Participants satisfying all selection criteria at the end of the 2-week, single blind, placebo run-in period were randomized to receive 12-week double-blind treatment with solifenacin 5 mg or 10 mg once daily, or placebo.

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

Primary outcomes:
measure: Change From Baseline to Week 12 in Bladder Wall Thickness
timeFrame: Baseline and Week 12
measure: Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Total Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12
timeFrame: Week 12
measure: Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) at Week 12
timeFrame: Week 12
measure: Change From Baseline to Week 6 and Week 12 in Bladder Wall Thickness
timeFrame: Baseline, Week 6 and Week 12
measure: Change From Baseline to Week 6 and Week 12 in Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine
timeFrame: Baseline, Week 6 and Week 12
measure: Change From Baseline to Week 12 in Mean Number of Events (Micturitions Plus Incontinence Episodes) Per 24 Hours
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Mean Number of Urgency Events Per 24 Hours
timeFrame: 12 weeks
measure: Change From Baseline to Week 12 in Mean Number of Micturitions Per 24 Hours
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Mean Number of Urgency Micturitions Per 24 Hours
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
timeFrame: Baseline and Week 12
measure: Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 3 or 4 Per 24 Hours
timeFrame: Baseline and Week 12
measure: Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 4 Per 24 Hours
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Mean Level of Urgency
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Total Urgency Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in Patient Perception of Bladder Condition (PPBC)
timeFrame: Baseline and Week 12
measure: Change From Baseline in Patient Assessment of Urgency Bother
timeFrame: Baseline and Week 12
measure: Change From Baseline in Patient Assessment of Treatment Satisfaction
timeFrame: Baseline and Week 12
measure: Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D
timeFrame: Baseline and Week 12
measure: Change From Baseline in EuroQoL 5-Dimension Questionnaire Visual Analog Scale
timeFrame: Baseline and Week 12
measure: Change From Baseline in Symptom Bother Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in Health-Related Quality of Life (HRQL)
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr)
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Total Urinary Nerve Growth Factor Normalized by Urine Creatinine
timeFrame: Baseline and Week 12
measure: Percentage of Participants With Improvement or Deterioration in Patient Perception of Bladder Condition (PPBC)
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: West Reading
country: United States
state: Pennsylvania
city: Graz
country: Austria
city: Linz
country: Austria
city: Linz
country: Austria
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Kortrijk
country: Belgium
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varba
country: Bulgaria
city: Victoria
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Barrie
country: Canada
state: Ontario
city: Brampton
country: Canada
state: Ontario
city: Brantford
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Sherbrooke
country: Canada
state: Quebec
city: Brno
country: Czechia
city: Hradec Kralove
country: Czechia
city: Podoli
country: Czechia
city: Marseille
country: France
city: Paris
country: France
city: Aachen
country: Germany
city: Berlin
country: Germany
city: Hannover
country: Germany
city: Munich
country: Germany
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
country: Hungary
city: Haifa
country: Israel
city: Petah Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Avellino
country: Italy
city: Milan
country: Italy
city: Milan
country: Italy
city: Rome
country: Italy
city: Varese
country: Italy
city: Arendal
country: Norway
city: Drammen
country: Norway
city: Haugesund
country: Norway
city: Tonsberg
country: Norway
city: Bydgoszcz
country: Poland
city: Krakow
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Timisoara
country: Romania
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhniy Novgorod
country: Russian Federation
city: Saint Peterburg
country: Russian Federation
city: Saint Peterburg
country: Russian Federation
city: Yaroslavl'
country: Russian Federation
city: Bardejov
country: Slovakia
city: Martin
country: Slovakia
city: Zilina
country: Slovakia
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Lund
country: Sweden
city: Stockholm
country: Sweden
city: Ankara
country: Turkey
city: Istanbul
country: Turkey
city: Kocaeli
country: Turkey
city: Harrow
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_CHAIR
References: