Therapy of the Overactive Bladder Syndrome

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of the present study is to investigate in patients with overactive bladder syndrome (OABS) whether a combination treatment of solifenacin with pelvic floor muscle training and whole body vibration training achieves a better treatment outcome than a treatment with solifenacin alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cantonal Hospital, Frauenfeld
• Collaborator: Astellas Pharma Inc
• Treatments: Solifenacin Succinate

Criteria

Inclusion Criteria:

• Female patients with symptoms of overactive bladder (urinary frequency and urgency with or without incontinence) for ≥ 3 months

• Age ≥ 18 years old

• Urinary frequency ≥ 8 micturitions on average per 24 hours during the 3-day micturition diary period

• At least 3 episodes of urgency with or without incontinence (≥ 3) during the 3-day micturition diary period

• Patient provides written informed consent

• Patient is willing to complete the micturition diary

Exclusion Criteria:

• Clinically significant bladder outflow obstruction at risk of urinary retention (at the discretion of the investigator)

• Significant post void residual volume (> 200ml)

• Uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contraindicated

• Neurological cause of abnormal detrusor activity

• Any clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study

• Current non-drug treatment including pelvic floor muscle and whole body vibration training

• Known contraindications for whole body vibration training (cardiovascular, neurological or orthopaedic diseases, diabetes, tumor, pacemaker)

• Pregnant women or women who intend to become pregnant during the study

• Known or suspected hypersensitivity to solifenacin or lactose

• Concomitant use of a strong cytochrome P450 3A4 inhibitor (e.g. ketoconazole)