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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01884753

Enrollment

279

Registered

2013-06-24

Start date

2014-02-02

Completion date

2021-06-30

Last updated

2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Urinary Tract Dysfunction, Overactive Bladder Syndrome

Keywords

lower urinary tract symptoms, overactive bladder syndrome, antimuscarinic drug, three-dimensional power Doppler ultrasound, sexual dysfunction

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 99 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Patients with a history of stroke.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
The subgroup differences of urethral/pelvic volume, hiatal area and rupture of puborectalis muscles	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.

Countries

Taiwan

Outcome results