An explorative analysis of the effect of a beta 3 adrenoreceptor agonist (Mirabegron) on urethral pressure variations during filling cystometry.
- Conditions
- 10046447overactive bladderurgency
- Registration Number
- NL-OMON46848
- Lead Sponsor
- Haaglanden Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 49
Female.
>18 years of age.
Mentally fit to consent.
(Referred with) Bothersome OAB symptoms (standard symptom and bother score)
Voiding diary with total urine production in 24 hour (morning to morning) <2200mL
Treating physician has indicated treatment with B3AA Mirabegron
Signed informed consent
May have had *unsatisfying- treatment with antimuscarinergic medication
Willing to stop medication for lower urinary tract dysfunction 2 days before urodynamic investigation (at entry of study)
Willing to start B3AA *study medication- after initial urodynamic investigation
* Sediment + or clinical signs of UTI at the start of the urodynamic investigation
* Necessity to perform CIC or significant post void residual (>100mL).
* Significant voiding abnormalities; bladder outlet obstruction (UDI >grade 1 or BOOI >20) or underactive or acontractile detrusor.
* Unwilling or unable * according to treating physician- to stop current treatment for lower urinary tract dysfunction.
* Treatment with intradetrusor botulinum toxin less than one year before urodynamic investigation (whether or not symptomatically effective).
* Having a contraindication for treatment with B3AA : severe renal impairment with GFR <15 mL/min/1.73m2 or patients requiring haemodialysis) or severe hepatic impairment (Child-Pugh Class C)
* Pregnancy or breastfeeding.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Number (proportion) of patients with a reduction of significant urethral<br /><br>pressure variations >15cmH2O on urodynamic investigation (two sequential<br /><br>standard filling cystometries until strong desire to void) while on treatment<br /><br>with beta 3 adrenoreceptor agonist.</p><br>
- Secondary Outcome Measures
Name Time Method