Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT01639794
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of non-neurogenic Lower Urinary Tract Symptoms (LUTS) with bothersome storage disorder defined as urgency, and/or frequency and/or Urge Urinary Incontinence (UUI) at the discretion of the Investigator
* Eligible to start Vesitirim™ 5 or 10mg according to SmPC (Summary of Product Characteristics )
Exclusion Criteria:
* History of stress incontinence
* Active urinary tract infection (confirmed by positive urine analysis)
* Symptoms suggestive of severe Bladder Outlet Obstruction (BOO) defined as Qmax\<10ml/sc and/or PVR\>150ml
* History of known hypersensitivity to solifenacin succinate, oxybutynin hydrochloride, other anti-cholinergics or lactose, to any component of the dosage form or any other allergy, which, in the opinion of the Investigator contraindicates their participation
* Uncontrolled Diabetes Mellitus
* History of drug and/or alcohol abuse at the time of enrolment
* History of acute urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow glaucoma or swallow anterior chamber or deemed to be at risk of these conditions
* Undergoing haemodialysis or has severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor
* History of urogenital tumours which in the opinion of the Investigator precludes their participation in the study
* Likely to participate in another study during study period of 12 weeks from study entry
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
35 Years
Study:
NCT01639794
Study Brief:
Protocol Section:
NCT01639794