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.
Lower Urinary Tract Dysfunction
Overactive Bladder Syndrome
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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.|
- Urethral/pelvic blood flow perfusion pattern between subgroups of women with lower urinary tracts [ Time Frame: 1 day ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Adult women with lower urinary tract symptoms
Adult women (not less than 20 year-old) with lower urinary tract symptoms
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|