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Effect van Mirabegron op de urethrale druk tijdens urodynamisch onderzoek

An explorative analysis of the effect of a beta 3 adrenoreceptor agonist (Mirabegron) on urethral pressure variations during filling cystometry

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26653
Enrollment
75
Registered
2014-11-03
Start date
2014-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

urinary urgency, urinarinary incontinence, over active bladder symptoms

Interventions

Start of mirabegron Second urodynamic investigation Voluntary questionnaire about sexual function

Sponsors

P. Groenendijk, Medisch Centrum Haaglanden, den haag
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Female patients, above age of 18, mentally fit to consent and indication for treatment with Mirabegron. Bothersome OAB symptoms. Voiding diary volume urine less then 2200ml. • 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 (mirabegron)

Exclusion criteria

Exclusion criteria: • Contraindications for the use of Mirabegron (severely impaired kidney- or liver function) • 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)

Design outcomes

Primary

MeasureTime frame
Effect of mirabegron on urethral pressure variations

Secondary

MeasureTime frame
• Difference of total number of urethral pressure variations on urodynamic investigation after treatment, compared to initial urodynamic investigation. • Difference in volume to first detrusor contraction between ‘before’ and ‘on treatment’. • Differences in volume to first sensation of filling, normal desire to void and strong desire to void, between ‘before’ and ‘on treatment’. • Difference in volume to first urethral pressure drop between ‘before’ and ‘on treatment’. • Difference in largest pressure drop (cmH2O) between ‘before’ and ‘on treatment’. • To explore the association of symptoms and voiding diary data before and on treatment with a beta 3 adrenoreceptor agonist with significant urethral pressure variations/ urethral pressure drops during urodynamic investigation (before and on treatment). • Sexual function as measured with a questionnaire before and on treatment with beta 3 adrenoreceptor agonist. Comparison of (grouped average) individual before and on treatment effect(s) of a beta 3 adrenoreceptor agonist on symptoms and voiding diary and urodynamic parameters

Contacts

Public ContactP. Groenendijk

Urologist MCH

p.groenendijk@mchaaglanden.nl070-3303055

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)