NCT01884753

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
279

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

February 2, 2014

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 13, 2023

Status Verified

August 1, 2021

Enrollment Period

7.4 years

First QC Date

June 19, 2013

Last Update Submit

September 12, 2023

Conditions

Lower Urinary Tract DysfunctionOveractive Bladder Syndrome

Keywords

lower urinary tract symptomsoveractive bladder syndromeantimuscarinic drugthree-dimensional power Doppler ultrasoundsexual dysfunction

Outcome Measures

Primary Outcomes (1)

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

    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.

    1 day

Secondary Outcomes (1)

  • Urethral/pelvic blood flow perfusion pattern after antimuscarinics

    12 weeeks

Other Outcomes (1)

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

    1 day

Study Arms (1)

Adult women with lower urinary tract symptoms

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

Eligibility Criteria

Age20 Years - 99 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with lower urinary tract symptoms

You may qualify if:

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

You may not qualify if:

  • Patients with a history of stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

MeSH Terms

Conditions

Lower Urinary Tract SymptomsSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital DiseasesUrogenital Diseases

Study Officials

  • Sheng-Mou Hsiao, MD

    Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

June 19, 2013

First Posted

June 24, 2013

Study Start

February 2, 2014

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

September 13, 2023

Record last verified: 2021-08

Locations

TW(1)