Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder.
SHRINK
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.
2 other identifiers
interventional
547
20 countries
79
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2010
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 19, 2010
CompletedFirst Submitted
Initial submission to the registry
March 24, 2010
CompletedFirst Posted
Study publicly available on registry
March 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2011
CompletedResults Posted
Study results publicly available
April 7, 2014
CompletedDecember 3, 2024
November 1, 2024
1.4 years
March 24, 2010
February 26, 2014
November 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline to Week 12 in Bladder Wall Thickness
Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.
Baseline and Week 12
Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12
Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations \[pg/mL\] by the urine creatinine concentrations (µmol/mL) from the same participant.
Week 12
Secondary Outcomes (23)
Total Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12
Week 12
Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) at Week 12
Week 12
Change From Baseline to Week 6 and Week 12 in Bladder Wall Thickness
Baseline, Week 6 and Week 12
Change From Baseline to Week 6 and Week 12 in Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine
Baseline, Week 6 and Week 12
Change From Baseline to Week 12 in Mean Number of Events (Micturitions Plus Incontinence Episodes) Per 24 Hours
Baseline and Week 12
- +18 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORParticipants received 2 placebo tablets once daily for 12 weeks.
Solifenacin 5 mg
EXPERIMENTALParticipants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
Solifenacin 10 mg
EXPERIMENTALParticipants received two 5 mg solifenacin tablets once daily for 12 weeks.
Interventions
Tablet for oral administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (79)
Unknown Facility
New York, New York, 11530, United States
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New York, New York, 12601, United States
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West Reading, Pennsylvania, 19611, United States
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Graz, A-8036, Austria
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Linz, 4020, Austria
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Linz, A-4020, Austria
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Kortrijk, 8500, Belgium
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Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Varba, 9010, Bulgaria
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Victoria, British Columbia, V8T 5G1, Canada
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Victoria, British Columbia, V8V 3N1, Canada
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Barrie, Ontario, L4M 7G1, Canada
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Brampton, Ontario, L6T 4S5, Canada
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Brantford, Ontario, N3R 4N3, Canada
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Kitchener, Ontario, N2N 2B9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Brno, 625 00, Czechia
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Hradec Králové, 500 05, Czechia
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Podolí, 147 00, Czechia
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Marseille, 13285, France
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Paris, 75970, France
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Aachen, 52074, Germany
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Berlin, 10115, Germany
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Hanover, 30625, Germany
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Munich, 81679, Germany
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Budapest, 1082, Hungary
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Budapest, 1115, Hungary
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Szeged, 6725, Hungary
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Székesfehérvár, 8000, Hungary
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Haifa, 31096, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Avellino, 83100, Italy
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Milan, 20132, Italy
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Milan, 20153, Italy
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Rome, 00133, Italy
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Varese, 21100, Italy
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Arendal, 4809, Norway
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Drammen, 3004, Norway
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Haugesund, 5507, Norway
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Tønsberg, 3103, Norway
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Bydgoszcz, 85-094, Poland
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Krakow, 31-530, Poland
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Warsaw, 00-846, Poland
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Warsaw, 01-432, Poland
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Warsaw, 02-005, Poland
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Warsaw, 02-929, Poland
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Timișoara, 300376, Romania
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Moscow, 101000, Russia
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Moscow, 105425, Russia
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Moscow, 115516, Russia
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Moscow, 117815, Russia
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Moscow, 117997, Russia
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Moscow, 119435, Russia
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Moscow, 123836, Russia
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Moscow, 125206, Russia
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Nizhny Novgorod, 603018, Russia
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Saint Peterburg, 197089, Russia
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Saint Peterburg, 199044, Russia
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Yaroslavl, Russia
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Bardejov, 085 01, Slovakia
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Martin, 036 59, Slovakia
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Žilina, 010 01, Slovakia
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Barcelona, 08036, Spain
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Madrid, 28031, Spain
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Madrid, 28046, Spain
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Madrid, 28905, Spain
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Lund, 22185, Sweden
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Stockholm, 14186, Sweden
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Ankara, 06018, Turkey (Türkiye)
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Istanbul, 34664, Turkey (Türkiye)
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Kocaeli, 41380, Turkey (Türkiye)
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Harrow, HA1 3JU, United Kingdom
Unknown Facility
London, SE5 9RS, United Kingdom
Unknown Facility
London, W2 2YP, United Kingdom
Related Publications (1)
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PMID: 37160401DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Company makes no warranties or representations of any kind as to the currency or completeness of the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose and shall not be liable for any damages.
Results Point of Contact
- Title
- Director Medical Affairs - Urology
- Organization
- Astellas Pharma Europe Ltd.
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Europe B.V.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2010
First Posted
March 26, 2010
Study Start
January 19, 2010
Primary Completion
June 23, 2011
Study Completion
June 23, 2011
Last Updated
December 3, 2024
Results First Posted
April 7, 2014
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.