overactive bladder clinical practice clinical trial integrated overactieve blaas klinische praktijk klinische studie integraal
Conditions
Interventions
Group 1: SNS treatment:
SNS is a rehabilitative treatment to be used to treat selected patients with OAB (Siegel 2000, Aboseif 2007) . In this technique, low-intensity electrical impulses are generat
Sponsors
Maastricht University Medical Center + , P.O.Box 5800, 6202 az, Maastricht, the Netherlands,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent has been obtained; 2. Written documentation has been obtained in accordance with local privacy requirements, where applicable; 3. Patient is male or female, aged between 18 and 75 years old (Amundsen 2005); 4. Patient weighs ≥ 40 kg; 5. Patient has symptoms of idiopathic OAB (frequency and urgency) with urinary incontinence immediately prior to qualification, determined by documented patient history; 6. 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); 7. 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); 8. Patient has a negative pregnancy test result if female and of childbearing potential; 9. 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; 10. 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
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 inv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The proportion of patients who have a treatment response of improvement of at least 2 categories on the PPBC (Coyne 2006). As stated before, the power calculation to define the sample size for this study is based on the PPBC; 2. The mean change from baseline to endpoint in Incontinence Episodes Frequency (IEF) as recorded in the 3 day micturition chart (frequency volume chart). Related to primary objective 2: Safety measures: 1. Adverse events; 2. Serious medical events. To evaluate the safety of the procedure through prospective observation of serious adverse events and serious adverse device effects. Endpoint: The analysis of the incidence of serious adverse device effects through the course of the study. Safety data (vital signs, occurrence and duration of adverse events (AEs), and drop-out/discontinuation during study due to AEs). Measurement of post void residual (PVR) urine volume. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intensity of urgency scale ( Patient Perception of Intensity of Urgency Sensation (PPIUS)) (Cartwright 2010); 2. Mean absolute change in number of voids/24 hrs (3-days micturition diary); 3. Volume involuntary loss of urine (from 3-days micturition diary); 4. Urinary Incontinence-Specific Quality-of-Life Instrument Dutch (I-QOL) Total score change from baseline, subscale change from baseline; 5. PRAFAB (Impact and severity of urinary incontinence) Total score change from baseline; 6. Patient's satisfaction; 7. Percentage patients with a positive response on "Behandeling Baat Schaal" . (score is 1 or 2, i.e., "fors verbeterd"or "verbeterd". | — |
Contacts
Public ContactBary Berghmans
Pelvic care Center Maastricht Maastricht University Medical Center + P.O.Box 5800
Outcome results
None listed