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

Completed

• Conditions: overactive bladder; urge; 10004994

• Registration Number: NL-OMON33785
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified