SOLIFENACIN SUCCINATE IN A FLEXIBLE DOSE REGIMEN WITH SIMPLIFIED BLADDER TRAINING VERSUS SOLIFENACIN SUCCINATE IN A FLEXIBLE DOSE REGIMEN ALONE IN A PROSPECTIVE, RANDOMIZED, PARALLEL GROUP, OVERACTIVE BLADDER SYMPTOM STUDY SOLAR - ND

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 706

Inclusion Criteria

At study entry 1. Male or female subject aged 61619; 18 years. 2. Written informed consent has been obtained. 3. Subject is capable of completing the simplified bladder training regimen correctly. 4. Subject is willing and able to complete the micturition diary correctly. 5. Symptoms of overactive bladder including urinary frequency, urgency with/without urge incontinence for 61619; 3 months. At randomization 6. Subject must experience the following symptoms during the 3 day micturition diary period At least 3 episodes of urge incontinence or At least 3 episodes of urgency. 7. Subject must experience frequency of micturition on average 61619; 8 times per 24-hour period during the 3-day micturition diary period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

At study entry 1. Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practicing 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 contraceptives. 2. Clinically significant outflow obstruction at the discretion of the investigator . 3. Significant post void residual volume PVR 200mL . 4. Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator for female subjects confirmed by a cough provocation test . 5. Subject with a neurological cause for abnormal detrusor activity. 6. 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. 7. Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated. 8. Non-drug treatment for OAB including electrostimulation therapy and pelvic floor exercises in the four weeks prior to the commencement of the study or during the study apart from those included in the study bladder training instructions . 9. Subject who has received cognitive bladder training in the last 6 months. 10. Subject who intends to commence bladder training other than the study regimen during the study. Any bladder training outside of the study regimen should be postponed until after the study . 11. Use of drugs intended to treat urinary incontinence, concomitant use of a strong CYP3A4 inhibitor, e.g. Ketoconazole see appendix 1 . 12. Myasthenia gravis or diabetic neuropathy. 13. Known or suspected hypersensitivity to solifenacin succinate, other anticholinergics or lactose. 14. Any clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study or includes a history of severe renal GFR 30 mL/min , or moderate, hepatic impairment, chronic intestinal disease, megacolon, bladder obstruction or chronic and severe constipation requiring treatment. 15. Participation in any clinical study within 30 days of randomization, or the limit set by national law, whichever is longer. 16. Employees of the Astellas Group, third parties associated with the study, or the study site. At randomization 17. Subject who did not complete the micturition diary according to the instructions.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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