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.

Overactive Bladder Syndrome Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884753
• Other study ID #: 102021-F
• Status: Completed
• Start date: February 2, 2014
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 99 Years

Eligibility

Inclusion Criteria:

• Women with lower urinary tract symptoms

• Not less than 20 years-old

Exclusion Criteria:

• Patients with a history of stroke.

Related Conditions & MeSH terms

• Lower Urinary Tract Dysfunction
• Lower Urinary Tract Symptoms
• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	New Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The subgroup differences of urethral/pelvic volume, hiatal area and rupture of puborectalis muscles	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.	1 day
Primary	Urethral/pelvic blood flow perfusion pattern between subgroups of women with lower urinary tracts	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.	1 day
Secondary	Urethral/pelvic blood flow perfusion pattern after antimuscarinics	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.	12 weeeks