The efficacy of pharmacological treatment of overactive bladder symptoms, evaluated by the PelFIs questionnaire.

The efficacy of pharmacological treatment of overactive bladder symptoms, evaluated by the PelFIs questionnaire. - Efficacy of pharmacological treatment in OAB

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33785

Enrollment

100

Registered

2009-06-15

Start date

2009-11-09

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

overactive bladder urge

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patient aged 18 and older. 2. Written informed consent has been obtained. 3. Patient is willing and able to complete the PelFIs questionnaire and diaries correctly. 4. Symptoms of overactive bladder: urinary frequency is 8 or more times per 24 hours and at least 3 urgency or urge incontinence episodes per 24 hours. 5. Not treated with conservative or pharmacological treatment for at least 3 weeks prior to the study.

Exclusion criteria

Exclusion criteria: 1. Total daily urine volume > 3000 ml as verified in the micturition diary. 2. Women of childbearing potential who are pregnant or intend to become pregnant during the study or who will be lactating during the study. 3. Clinically significant outflow obstruction. 4. Significant post void residual volume (PVR>200ml) measured by abdominal ultrasound. 5. Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor. 6. Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs. 7. Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which makes the use of anticholinergics contra-indicated. 8. Known or suspected hypersensitivity to solifenacin or other anticholinergics or lactose. 9. Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the study.

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints: PelFIs questionnaire The patient assessment of the degree of complaints due to pelvic floor dysfunction will be performed using the validated PelFIs questionnaire at all visits. Micturition diary Time of micturition, urgency and incontinence, pad use and volumes voided per micturition will be recorded by the patients in the micturition diary. In addition, time of getting up and going to bed will be recorded. Also used incontinence pads wil be collected during 24 hours. Padtest Used incontinence pads wil be collected during 24 hours. Pelvic floor examination (PFE) A qualitative as well as quantitative examination of the pelvic floor with use of biofeedback will be performed by a qualified physiotherapist at visit 2 and 5.	—

Measure

Time frame

Main study parameters/endpoints: PelFIs questionnaire The patient assessment of the degree of complaints due to pelvic floor dysfunction will be performed using the validated PelFIs questionnaire at all visits. Micturition diary Time of micturition, urgency and incontinence, pad use and volumes voided per micturition will be recorded by the patients in the micturition diary. In addition, time of getting up and going to bed will be recorded. Also used incontinence pads wil be collected during 24 hours. Padtest Used incontinence pads wil be collected during 24 hours. Pelvic floor examination (PFE) A qualitative as well as quantitative examination of the pelvic floor with use of biofeedback will be performed by a qualified physiotherapist at visit 2 and 5.

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Secondary

Measure	Time frame
Nvt.	—

Countries

Netherlands

Outcome results