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.

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Far Eastern Memorial Hospital
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Sheng-Mou Hsiao, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01884753
First received: June 19, 2013
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition
Lower Urinary Tract Dysfunction
Overactive Bladder Syndrome

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Weeks
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.

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • Urethral/pelvic blood flow perfusion pattern between subgroups of women with lower urinary tracts [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Urethral/pelvic blood flow perfusion pattern after antimuscarinics [ Time Frame: 12 weeeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • The subgroup differences of urethral/pelvic volume, hiatal area and rupture of puborectalis muscles [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 330
Study Start Date: June 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adult women with lower urinary tract symptoms
Adult women (not less than 20 year-old) with lower urinary tract symptoms

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women with lower urinary tract symptoms

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with a history of stroke.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01884753

Contacts
Contact: Shen-Mou Hsiao, MD +886-2-89667000 ext 1424 smhsiao2@gmail.com

Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
New Taipei, Taiwan, 220
Contact: Sheng-Mou Hsiao, MD    +886-2-89667000 ext 1424    smhsiao2@gmail.com   
Principal Investigator: Sheng-Mou Hsiao, MD         
Sponsors and Collaborators
Far Eastern Memorial Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Sheng-Mou Hsiao, MD Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
  More Information

No publications provided

Responsible Party: Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01884753     History of Changes
Other Study ID Numbers: 102021-F
Study First Received: June 19, 2013
Last Updated: March 31, 2014
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Far Eastern Memorial Hospital:
lower urinary tract symptoms
overactive bladder syndrome
antimuscarinic drug
three-dimensional power Doppler ultrasound
sexual dysfunction

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Syndrome
Urinary Bladder, Overactive
Disease
Pathologic Processes
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 21, 2014