Clinical trial NCT01884753: 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.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2013-06-24
Enrollment: 279
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with lower urinary tract symptoms

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients with a history of stroke.

Primary outcomes:
measure: Urethral/pelvic blood flow perfusion pattern between subgroups of women with lower urinary tracts
timeFrame: 1 day
Secondary outcomes:
measure: Urethral/pelvic blood flow perfusion pattern after antimuscarinics
timeFrame: 12 weeeks
Other outcomes:
measure: The subgroup differences of urethral/pelvic volume, hiatal area and rupture of puborectalis muscles
timeFrame: 1 day
Locations:
city: New Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
name: Sheng-Mou Hsiao, MD
role: PRINCIPAL_INVESTIGATOR
References: