SOLIFENACIN SUCCINATE for Overactive bladder | Daytime urinary incontinence

Inclusion criteria

• {"criterion_text":"- 1.\tThe participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation any study specific procedures.\n- 2.\tAge 5 to 14 years (inclusive) at the time of signing the consent.\n- 3.\tOveractive bladder as per ICCS criteria\n- 4.\tAt least 2 daytime urinary incontinens episodes per week\n- 5.\tInadequate effect of 4 weeks urotherapy (non-pharmacological treatment)\n- 6.\tNo previous treatment with solifenacin, mirabegron, intradetrusor botulinum toxin injections\n- 7.\tNo current constipation as per ROME IV criteria or fecal incontinence (laxative treatment is accepted)\n- 8.\tPer investigator’s judgment, the participant can swallow or can learn to swallow study medication"}

Exclusion criteria

• {"criterion_text":"- Inability of the patent(s) or parental custody holder(s) to understand the Danish written and oral information\n- Female subjects of childbearing potential\n- Inability to swallow study medication\n- Known or suspected hypersensitivity to study medication\n- Any contraindication to the use of the study medication\n- Known urogenital anatomical abnormalities affecting lower urinary tract function\n- Known kidney or bladder stones\n- Known diabetes insipidus (central or nephrogenic)\n- Ongoing symptomatic urinary tract infection (dysuria, fever, bacterial growth by urine culturing)\n- Recurrent urinary tract infection or ongoing prophylactic antibiotic treatment\n- Known QTc prolongation, QTc >460 ms, or risk of QTc prolongation (hypokalaemia, exercise-induced syncope, or familial long QT syndrome)\n- Other significant ECG abnormalities\n- Known hypertension\n- ≤3 daily voiding, evaluated by 48-hour frequency-volume chart\n- Uroflowmetry suggestive of other pathology than OAB (staccato-shaped, interrupted-shaped, or plateau-shaped curve)\n- Post-void residual >50 ml after doublet voiding\n- Dipstick haematuria (≥2+ erythrocytes) or macroscopic haematuria\n- Pregnancy or breastfeeding\n- Ongoing constipation according to Rome IV-criteria which is intractable to medication or fecal incontinence"}

Primary endpoints

• {"endpoint_text":"- The primary outcome measure is treatment response as defined by non-response (<50% decrease in number of wet days) and response (50-100% decrease in number of wet days), assessed by a change from visit 2 and across the 12-week pharmacological treatment period. The number of wet days is assessed pr. 7 days by DryPie. The treatment response will be evaluated for solifenacin, mirabegron and combination of solifenacin and mirabegron.","definition_or_measurement_approach":"Treatment response defined as non-response (<50% decrease in number of wet days) and response (50-100% decrease in number of wet days); assessed as change from visit 2 across the 12-week pharmacological treatment period. Number of wet days is assessed per 7 days using DryPie; evaluated separately for each treatment arm (solifenacin, mirabegron, combination)."}

Secondary endpoints

• {"endpoint_text":"- Change in number of wet days pr. 7 days assessed by Dry Pie, baseline to 18 weeks","definition_or_measurement_approach":"Change from baseline to 18 weeks in number of wet days per 7 days assessed by DryPie."}
• {"endpoint_text":"- Change in incontinence severity score pr. 7 days assessed by Dry Pie, baseline to 18 weeks","definition_or_measurement_approach":"Change from baseline to 18 weeks in incontinence severity score per 7 days assessed by DryPie."}
• {"endpoint_text":"- Change in urge severity quantified by Bower VAS Urgency, baseline to 18 weeks","definition_or_measurement_approach":"Change from baseline to 18 weeks in urge severity measured by Bower Visual Analogue Scale (VAS) for urgency."}
• {"endpoint_text":"- Change in maximum volume voided (MVV), baseline to 18 weeks","definition_or_measurement_approach":"Change from baseline to 18 weeks in maximum volume voided (MVV)."}
• {"endpoint_text":"- Change in age standardized MVV (MVV as a percent of expected bladder capacity (EBC)), baseline to 18 weeks","definition_or_measurement_approach":"Change from baseline to 18 weeks in MVV expressed as percent of expected bladder capacity (age-standardized)."}
• {"endpoint_text":"- Change in average voided volume (AVV), baseline to 18 weeks","definition_or_measurement_approach":"Change from baseline to 18 weeks in average voided volume (AVV)."}
• {"endpoint_text":"- Change in micturition frequency, baseline to 18 weeks","definition_or_measurement_approach":"Change from baseline to 18 weeks in micturition frequency."}
• {"endpoint_text":"- Change in fluid-intake, baseline to 18 weeks","definition_or_measurement_approach":"Change from baseline to 18 weeks in fluid intake."}
• {"endpoint_text":"- Change in maximum flow rate (Qmax) assessed by uroflowmetry, baseline to 18 weeks","definition_or_measurement_approach":"Change from baseline to 18 weeks in maximum flow rate (Qmax) measured by uroflowmetry."}
• {"endpoint_text":"- Change in Pediatric incontinence questionnaire total score, baseline to 18 weeks","definition_or_measurement_approach":"Change from baseline to 18 weeks in Pediatric Incontinence Questionnaire total score."}
• {"endpoint_text":"- Change in WHO-5 total score, baseline to 18 weeks","definition_or_measurement_approach":"Change from baseline to 18 weeks in WHO-5 well-being total score."}
• {"endpoint_text":"- Adverse event (AE), serious adverse event (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) monitoring","definition_or_measurement_approach":"Safety monitoring including recording and reporting of AEs, SAEs, and SUSARs per standard pharmacovigilance procedures."}
• {"endpoint_text":"- Change in blood pressure and pulse, baseline to 18 weeks","definition_or_measurement_approach":"Change from baseline to 18 weeks in blood pressure and pulse measurements."}
• {"endpoint_text":"- Change in ultrasonic assessed post-void residual urine, baseline to 18 weeks","definition_or_measurement_approach":"Change from baseline to 18 weeks in post-void residual urine measured by ultrasound."}
• {"endpoint_text":"- Identifications of ECG abnormalities by electrocardiogram","definition_or_measurement_approach":"ECG assessments to identify any ECG abnormalities."}
• {"endpoint_text":"- Identification of urinary tract infection by urine dipstick and verified by routine urine cultivation","definition_or_measurement_approach":"Urine dipstick screening with verification by routine urine culture to identify urinary tract infection."}
• {"endpoint_text":"- Treatment response of solifenacin, mirabegron and combination of solifenacin and mirabegron, baseline across 18 week treatment period","definition_or_measurement_approach":"Assessment of treatment response for each arm across the 18-week treatment period (as defined for primary endpoint)."}

Denmark

Earliest CTIS Part Ii Submission Date

13-04-2024

Latest Decision Or Authorization Date

12-06-2024

Processing Time Days

60

Number Of Sites

5

Number Of Participants

236

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"","organisation_type":"Educational Institution"}