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, randomized, placebo-controlled, parallel group, multicentre study - SHRINK

Phase 1

Conditions: Overactive bladder
MedDRA version: 12.0Level: LLTClassification code 10059617Term: Overactive bladder

Registration Number: EUCTR2008-005215-17-SK

Lead Sponsor: Astellas Pharma Europe Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 639

Inclusion Criteria

Subject is eligible for the study if all of the following apply:
1. The subject should be female aged greater than or equal to 18 years of age.
2. The subject should have symptoms of overactive bladder (OAB), including urinary frequency, urgency or urge incontinence, for greater than or equal to 3 months.
3. The subject should have an urodynamic diagnosis of detrusor overactivity (DO).
4. The subject should be either naïve to anti-muscarinic treatment (i.e. no prior history of use of antimuscarinic agents) or 6-months anti-muscarinic treatment free i.e. have had no anti-muscarinic treatment within 6 months) prior to the screening visit.
5. The subject should have a bladder post-void residual volume of less than 30ml.
6. The subject has provided Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) prior to any study-related procedures.
7. The subject is available to complete the study.
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

Subject will be excluded from participation if any of the following apply:
1. The subject has a history of stress urinary incontinence, uretheral sphincter incompetence or neurogenic detrusor overactivity.
2. The subject has a history, signs or symptoms suggestive of urinary tract infection (confirmed by positive urine analysis), obstruction or urogenital pro-lapse (greater than grade II).
3. The subject has a history of urinary tract operation within 6 months prior to screening.
4. The subject has an indwelling catheter or permanent catheter fitted.
5. The subject has a history of pelvic area radiotherapy treatment.
6. The subject has uncontrolled diabetes mellitus.
7. The subject has a history of fibromyalgia.
8. The subject is post-partum or breast-feeding within 3 months prior to screening visit.
9. The subject is 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).
10. The subject has a positive pre–study hepatitis B surface antigen, hepatitis C antibody or HIV result at time of screening.
11. The subject has a history of drug and / or alcohol abuse at time of screening.
12. The subject has a history of known or suspected 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.
13. The subject has a 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.
14. The subject is undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment or who are on treatment with a potent CYP3A4 inhibitor, e.g. Ketoconazole.
15. The subject has started or had any dose(s) changes of medication, described in the list in appendix 1B (list of medications permitted with restrictions), within 1 month prior to screening, which will interfere with the study procedures or compromise safety.
16. The subject is 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 in appendix 1A (list of prohibited medications).
17. The subject is 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, as described in the list in appendix 1A (list of prohibited medications)
18. The subject has any clinically significant abnormality following Investigator review of the physical examination which, in the opinion of the Investigator, contraindicates her participation.
19. The subject has any clinically significant abnormal heart rate or blood pressure measurements, at the screening visit, which, in the opinion of the Investigator, prevent safe participation in the study.
20. The subject, in the opi