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.
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|ClinicalTrials.gov Identifier: NCT01884753|
Recruitment Status : Recruiting
First Posted : June 24, 2013
Last Update Posted : April 28, 2020
|Condition or disease|
|Lower Urinary Tract Dysfunction Overactive Bladder Syndrome|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||330 participants|
|Target Follow-Up Duration:||12 Weeks|
|Official Title:||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.|
|Actual Study Start Date :||February 2, 2014|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Adult women with lower urinary tract symptoms
Adult women (not less than 20 year-old) with lower urinary tract symptoms
- Urethral/pelvic blood flow perfusion pattern between subgroups of women with lower urinary tracts [ Time Frame: 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.
- Urethral/pelvic blood flow perfusion pattern after antimuscarinics [ Time Frame: 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.
- The subgroup differences of urethral/pelvic volume, hiatal area and rupture of puborectalis muscles [ Time Frame: 1 day ]we will use 4 D ultrasound to assess the urethral/pelvic volume, hiatal area and rupture of puborectalis muscles among subgroups of women with lower urinary tract symptoms, and the above results will be compared to that of the control group. Besides, the correlation of imaging findings and clinical symptoms (such as lower urinary tract symptoms and sexual dysfunction) will be compared.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884753
|Contact: Shen-Mou Hsiao, MD||+886-2-89667000 ext firstname.lastname@example.org|
|Far Eastern Memorial Hospital||Recruiting|
|New Taipei, Taiwan, 220|
|Contact: Sheng-Mou Hsiao, MD +886-2-89667000 ext 1424 email@example.com|
|Principal Investigator: Sheng-Mou Hsiao, MD|
|Principal Investigator:||Sheng-Mou Hsiao, MD||Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital|