Correlations of 3D Urethral and Paraurethral Sonographic Findings With Urodynamic Studies, Lower Urinary Tract Symptoms & Sexual Dysfunction in Female Patients With Lower Urinary Tract Symptoms.

Completed

• Conditions: Lower Urinary Tract Dysfunction; Overactive Bladder Syndrome

• Registration Number: NCT01884753
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

The main purpose of this study is to get the urethra and pelvic sonographic imaging by 4D ultrasound examinations, and to correlate the sonographic findings with urodynamic variables, pad weights and LUTS. Besides, the associations of the blood flow of vagina/urethra and sexual dysfunction can be explored.

Detailed Description

Female lower urinary tract dysfunction includes stress urinary incontinence, overactive bladder syndrome and voiding dysfunction. There are a lot of bladder studies, such as researches of bladder wall thickness and bladder volume. However, there were few studies of urethra for female patients with lower urinary tract symptoms (LUTS), especially for storage disorder. Thus, the main purpose of this study is to get the urethra and pelvic sonographic imaging by 4D ultrasound examinations, and to correlate the sonographic findings with urodynamic variables, pad weights and LUTS. The investigators hope to identify important LUTS sonographic biomarkers that can be used by primary physicians as a tool for assess female LUTS, and thus decreasing the need of further invasive urodynamic studies.

Besides, the associations of the blood flow of vagina/urethra and sexual dysfunction (assessed by female sexual function index) can be explored.

In addition, women who receive antimuscarinics treatment will receive follow-up 4D imaging and request to complete questionnaire 12 weeks later.

Study Timeline

• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-24
• Study Start: 2014-02-02
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-08
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 279

Inclusion Criteria

• Women with lower urinary tract symptoms
• Not less than 20 years-old

Exclusion Criteria

• Patients with a history of stroke.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Urethral/pelvic blood flow perfusion pattern between subgroups of women with lower urinary tracts	1 day	We will get the associations of urethral/pelvic blood flow perfusion pattern between subgroups of women with lower urinary tracts, and the above results will be compared to that of the asymptomatic control group.

Secondary Outcome Measures

Name	Time	Method
Urethral/pelvic blood flow perfusion pattern after antimuscarinics	12 weeeks	We will compare the urethral/pelvic blood flow perfusion pattern between the baseline and 12 weeks' antimuscarinic treatment (solifenacin 5 mg SR qd or tolerodine 4 mg ER qd) in women with overactive bladder syndrome.

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 New Taipei, Taiwan