Solifenacin Succinate 5mg or 10mg Once Daily in the Treatment of Urgency Symptoms
SUNRISE
Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomized, Placebo-controlled, Double-blind Trial
1 other identifier
interventional
973
14 countries
78
Brief Summary
Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose increase. Primary efficacy assessment of OAB symptoms by patient diaries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2004
78 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
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 4, 2008
CompletedSeptember 18, 2014
September 1, 2014
1.5 years
December 2, 2008
September 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in mean number of urgency episodes/24 hours at EOS -from the Patient Perception of Intensity of Urgency Scale at void (PPIUS) grades 3 and 4
Week 16
Secondary Outcomes (6)
Change from baseline in mean number of urgency episodes (PPIUS grades 1-4)
Week 16
Change from baseline in the mean number of micturition, incontinence and urge incontinence (PPIUS grade 4) episodes per 24 hours
Week 16
Change from baseline in patient perception of bladder condition (PBC)
Week 16
Change from baseline in patient perception of urgency 'bother' (UB-VAS)
Week 16
Percentage of patients requiring an increase in the dose of the study medication
Week 8
- +1 more secondary outcomes
Study Arms (2)
I
EXPERIMENTALSolifenacin succinate 5/10mg
II
EXPERIMENTALPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Patient is willing and able to complete the micturition diary correctly.
- Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for \>= 3 months
- At least 3 episodes of urgency with or without incontinence in last 3 days
- At least three episodes of urgency with or without incontinence (PPIUS grade 3 or 4) during the 3-day micturition diary period
- Patient must experience frequency of micturition on average \>= 8 times per 24-hour period during the 3-day micturition diary period
You may not qualify if:
- Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practising an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants and injectable or patch contraceptives
- Clinically significant outflow obstruction (at the discretion of the investigator)
- Significant post void residual volume (PVR\>200ml)
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
- Patient with indwelling catheters or practising intermittent self-catheterisation
- Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
- Hypersensitivity to solifenacin or to any of the excipients, uncontrolled narrow angle glaucoma, myasthenia gravis, urinary or gastric retention, severe renal impairment (GFR ≥30 ml/min), moderate or severe hepatic impairment, chronic intestinal disease, megacolon, requirement for dialysis, concomitant use of a strong CYP3A4 inhibitor, e.g. ketoconazole
- Non drug OAB treatment such as bladder-training, biofeedback and pelvic floor exercises are permissible if established at least 4 weeks prior to study start and intended to be continued throughout the study; electrostimulation therapy is not permissible at any time
- Use of drugs intended to treat urinary incontinence
- Diabetic neuropathy
- Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial
- Participation in any clinical trial within 30 days prior to randomisation
- Employees of the Yamanouchi Group, third parties associated with the study, or the study site
- Patient who did not complete the micturition diary according to the instructions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
Unknown Facility
Antwerp, Belgium
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Bruges, Belgium
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Brussels, Belgium
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Ghent, Belgium
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Hasselt, Belgium
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Kortrijk, Belgium
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Leuven, Belgium
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Liège, Belgium
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Ostrava, Czechia
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Prague, Czechia
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Zlín, Czechia
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Al Mansurah, Egypt
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Lille, France
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Lomme, France
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Mulhouse, France
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Nantes, France
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Nîmes, France
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Paris, France
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Aichach, Germany
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Bad Neuenaher, Germany
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Bamberg, Germany
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Bautzen, Germany
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Berlin, Germany
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Dierdorf, Germany
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Dülmen, Germany
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Düsseldorf, Germany
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Frankfurt, Germany
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Henningsdorf, Germany
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Munich, Germany
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Neustadt, Germany
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Nuremberg, Germany
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Planegg, Germany
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Athens, Greece
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Crete, Greece
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Ioannina, Greece
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Budapest, Hungary
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Nyíregyháza, Hungary
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Pécs, Hungary
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Szeged, Hungary
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Tatabánya, Hungary
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Bari, Italy
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Catanzaro, Italy
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Cinisello Balsamo, Italy
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Magenta, Italy
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Modena, Italy
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Perugia, Italy
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Turin, Italy
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Udine, Italy
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Bydgoszcz, Poland
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Wroclaw, Poland
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Abrantes, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Santarém, Portugal
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Moscow, Russia
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Banska Bysterica, Slovakia
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Martin, Slovakia
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Žilina, Slovakia
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Barcelona, Spain
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Coaña, Spain
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Córdoba, Spain
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Madrid, Spain
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Mérida, Spain
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San Cristóbal de La Laguna, Spain
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Seville, Spain
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Birmingham, United Kingdom
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Cottingham, United Kingdom
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Croydon, United Kingdom
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Edinburgh, United Kingdom
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Huntingdon, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Oldham, United Kingdom
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Stoke-on-Trent, United Kingdom
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Sunderland, United Kingdom
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Torbay, United Kingdom
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Welwyn Garden City, United Kingdom
Unknown Facility
Worthing, United Kingdom
Related Publications (2)
Cardozo L, Hessdorfer E, Milani R, Arano P, Dewilde L, Slack M, Drogendijk T, Wright M, Bolodeoku J; SUNRISE Study Group. Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial. BJU Int. 2008 Nov;102(9):1120-7. doi: 10.1111/j.1464-410X.2008.07939.x. Epub 2008 Oct 6.
PMID: 18990175BACKGROUNDStoniute 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Central Contact
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 4, 2008
Study Start
April 1, 2004
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
September 18, 2014
Record last verified: 2014-09