Integrated Overactive Bladder Clinical Trial in clinical practice III

Conditions: 10038365
bladder overactivity
urgency
10004994

Registration Number: NL-OMON38014

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 166

Inclusion Criteria

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).
9. Patient has a negative pregnancy test result if female and of childbearing potential.
10. Patient has a negative urine dipstick reagent strip test at start treatment day 1 (for nitrites, blood and leukocyte esterase) and, in the investigator*s opinion, patient is asymptomatic for UTI on day of treatment.
11. Patient is able to complete study requirements including using the toilet without assistance, is able to collect volume voided per micturition measurements over a 24- hour period, complete micturition diaries and questionnaires, and attend all study visits in the opinion of the coordinating investigator.

Exclusion Criteria

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
surgery (including minimally invasive surgery) within 1 year of qualification for: stress incontinence, uterine prolapse, rectocele, or cystocele
9. patient has a history of interstitial cystitis/painful bladder syndrome, in the opinion of the coordinating investigator
10. patient has an active genital infection, other than genital warts, either concurrently or within 4 weeks prior to qualification
11. patient has a history or current diagnosis of bladder cancer or other urothelial malignancy, and/or has un-investigated suspicious urine cytology results. Suspicious urine cytology abnormalities require that urothelial malignancy is ruled out to the satisfaction of the investigator according to local site practice.
12. patient is male with previous or current diagnosis of prostate cancer or a prostate specific antigen (PSA) level of > 10 ng/L at screening. Patients with a PSA level of >= 4 ng/L but <= 10 ng/L must have prostate cancer ruled out to the satisfaction of the investigator according to local site practice
13. patient has evidence of urethral and/or bladder outlet obstruction, in the opinion of the coordinating investigator at qualification or start treatment day 1.
14. patient has had urinary retention or an elevated PVR urine volume that has been treated with an intervention (such as catheterization) within 6 months of qualification. Note: voiding difficulties as a result of surgical procedures that resolved within 24 hours are not exclusionary.
15. patient has a 24-hour total volume of urine voided > 3000 mL, collected over 24 consecutive hours during the 3-day bladder diary collection period prior to treatment day 1.
16. patient has a history of 2 or more urinary tract infections within 6 months of qualification.
17. patient has a serum creatinine level > 2 times the upper limit of normal at qualification.
18. patient has current or previous un-investigated hematuria. Patient with investigated hematuria may enter the study if urol

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* outcome measures related to primary objectives:<br /><br>The proportion of patients who have a treatment response of improvement of at<br /><br>least 2 categories on the PPBC (Coyne 2005) (Appendix 14). As stated before,<br /><br>the power calculation to define the sample size for this study is based on the<br /><br>PPBC<br /><br>Number of episodes of urinary urgency incontinence as registered in the 3 day<br /><br>micturition diary (Appendix 8).<br /><br><br /><br><br /><br>References<br /><br>Coyne KS, Zyczynski T, Margolis MK, Elinoff V, Roberts RG. Validation of an<br /><br>overactive bladder awareness tool for use in primary care settings.<br /><br>Adv Ther. 2005 Jul-Aug;22(4):381-94</p><br>

Secondary Outcome Measures