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Completed

NCT Number: 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.

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.

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Key information

Age range

20 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with a history of stroke.

Treatment and study plan

Primary outcomes

  1. Urethral/pelvic blood flow perfusion pattern between subgroups of women with lower urinary tracts

    Time frame: 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 outcomes

  1. Urethral/pelvic blood flow perfusion pattern after antimuscarinics

    Time frame: 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 outcomes

  1. The subgroup differences of urethral/pelvic volume, hiatal area and rupture of puborectalis muscles

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Jun 24, 2013
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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