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.

NCT ID: NCT01884753

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 279 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-02
• Study Completion Date: 2021-06-30

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.

Conditions

Lower Urinary Tract Dysfunction; Overactive Bladder Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adult women with lower urinary tract symptoms

Adult women (not less than 20 year-old) with lower urinary tract symptoms

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Patients with a history of stroke.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Far Eastern Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sheng-Mou Hsiao

Chief, Department of Obstetrics & Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheng-Mou Hsiao, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital

Locations

Far Eastern Memorial Hospital

New Taipei City, , Taiwan

Countries

Taiwan

Other Identifiers

102021-F

Identifier Type: -

Identifier Source: org_study_id