Integrated Overactive Bladder Clinical Trial in clinical practice III - INTACT III

Medisch Universitair Ziekenhuis Maastricht0 sites166 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

Medisch Universitair Ziekenhuis Maastricht

•OAB patients eligible for SNS and botulinum toxin type A
•To be included in the study, the MUMC \+ urologist will check whether or not the patient meets the following criteria at recruitment/assessment:
•1\. Patient, who after non\-successful INTACT I and II or was a non\-responder to conservative treatments as specified in INTACT I and to PTNS as specified in INTACT II, was referred to a MUMC\+ urologist.
•2\. Written informed consent has been obtained.
•3\. Written documentation has been obtained in accordance with local privacy requirements, where applicable.
•4\. Patient is male or female, aged between 18 and 75 years old (Amundsen 2005\).
•5\. Patient weighs \>\= 40 kg.
•6\. Patient has symptoms of idiopathic OAB (frequency and urgency) with urinary incontinence immediately prior to qualification, determined by documented patient history.
•7\. Patient experiences a mean of 3 episodes of urinary urgency incontinence in the 3\-day patient bladder diary completed during the qualification period (qualification day \-14 to start treatment day 1\)
•8\. Patient experiences urinary frequency, defined as an average of \>\= 8 micturitions (toilet voids) per day i.e. a total \>\= 24 micturitions in the 3\-day patient micturition diary completed during the qualification period (qualification day \-14 to start treatment day 1\).

•OAB patients not eligible for SNS and botulinum toxin type A
•1\. residual urine after micturition \> 100 cc determined using sonography or catheterisation.
•2\. presence of urinary tract infection (UTI), determined using urinary sticks. (temporarely until UTI has been solved by antibiotics, then still potential candidate)
•3\. patient has symptoms of overactive bladder due to any known neurological reason (eg, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer\*s disease, Parkinson\*s disease, etc)
•4\. patient has a predominance of stress incontinence in the opinion of the coordinating investigator, determined by patient history
•5\. patient has received anticholinergics or any other medications or pelvic physiotherapy or PTNS to treat symptoms of overactive bladder, including nocturia, within 3 months of start treatment day 1\.
•6\. patient uses chronic intermittent catheterisation (CIC) or indwelling catheter to manage his or her urinary incontinence
•7\. patient has been treated with any intravesical pharmacologic agent (eg, capsaicin, resiniferatoxine) within 12 months of start treatment day 1
•8\. patient has history or evidence of any pelvic or urological abnormalities, bladder surgery or disease, other than \*overactive bladder\*, that may affect bladder function including but not limited to:
•bladder stones and/or bladder stone surgery at the time of\*qualification or within 6 months prior to qualification