Clinical trial NCT00801944: Solifenacin Succinate 5mg or 10mg Once Daily in the Treatment of Urgency Symptoms
Official title: Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomized, Placebo-controlled, Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Bladder, Overactive
Keywords: Overactive Bladder
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-12-04
Enrollment: 973
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose increase. Primary efficacy assessment of OAB symptoms by patient diaries.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: Week 16
Secondary outcomes:
measure: Change from baseline in mean number of urgency episodes (PPIUS grades 1-4)
timeFrame: Week 16
measure: Change from baseline in the mean number of micturition, incontinence and urge incontinence (PPIUS grade 4) episodes per 24 hours
timeFrame: Week 16
measure: Change from baseline in patient perception of bladder condition (PBC)
timeFrame: Week 16
measure: Change from baseline in patient perception of urgency 'bother' (UB-VAS)
timeFrame: Week 16
measure: Percentage of patients requiring an increase in the dose of the study medication
timeFrame: Week 8
measure: Patient assessment of treatment satisfaction (TS-VAS)
timeFrame: Weeks 4, 8 and 12
Other outcomes:
Locations:
city: Antwerp
country: Belgium
city: Brugge
country: Belgium
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Hasselt
country: Belgium
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Ostrava
country: Czech Republic
city: Prague
country: Czech Republic
city: Zlin
country: Czech Republic
city: Mansoura
country: Egypt
city: Lille
country: France
city: Lomme
country: France
city: Mulhouse
country: France
city: Nantes
country: France
city: Nimes
country: France
city: Paris
country: France
city: Aichach
country: Germany
city: Bad Neuenaher
country: Germany
city: Bamberg
country: Germany
city: Bautzen
country: Germany
city: Berlin
country: Germany
city: Dierdorf
country: Germany
city: Duelmen
country: Germany
city: Dusseldorf
country: Germany
city: Frankfurt
country: Germany
city: Henningsdorf
country: Germany
city: Munich
country: Germany
city: Neustadt
country: Germany
city: Nurnberg
country: Germany
city: Planegg
country: Germany
city: Athens
country: Greece
city: Crete
country: Greece
city: Ioannina
country: Greece
city: Budapest
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Tatabanya
country: Hungary
city: Bari
country: Italy
city: Catanzaro
country: Italy
city: Cinisello Balsamo
country: Italy
city: Magenta
country: Italy
city: Modena
country: Italy
city: Perugia
country: Italy
city: Turin
country: Italy
city: Udine
country: Italy
city: Bydgoszcz
country: Poland
city: Wroclaw
country: Poland
city: Abrantes
country: Portugal
city: Lisbon
country: Portugal
city: Porto
country: Portugal
city: Santarem
country: Portugal
city: Moscow
country: Russian Federation
city: Banska Bysterica
country: Slovakia
city: Martin
country: Slovakia
city: Zilina
country: Slovakia
city: Barcelona
country: Spain
city: Coana
country: Spain
city: Cordoba
country: Spain
city: Madrid
country: Spain
city: Merida
country: Spain
city: San Cristobal de la Laguna
country: Spain
city: Sevilla
country: Spain
city: Birmingham
country: United Kingdom
city: Cottingham
country: United Kingdom
city: Croydon
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Huntingdon
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Oldham
country: United Kingdom
city: Stoke on Trent
country: United Kingdom
city: Sunderland
country: United Kingdom
city: Torbay
country: United Kingdom
city: Welwyn Garden City
country: United Kingdom
city: Worthing
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Central Contact
role: STUDY_CHAIR
References:
citation: 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.