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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46848

Enrollment

Registered

2014-10-13

Start date

2015-05-07

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

overactive bladder urgency

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: * 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

Design outcomes

Primary

Measure	Time frame
Number (proportion) of patients with a reduction of significant urethral pressure variations >15cmH2O on urodynamic investigation (two sequential standard filling cystometries until strong desire to void) while on treatment with beta 3 adrenoreceptor agonist.	—

Secondary

Measure	Time 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	—

Measure

Time 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

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Countries

Netherlands

Outcome results