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Bladder Wall Blood Perfusion Pattern and Sexual Dysfunction in Female Patients With Lower Urinary Tract Symptoms, and the Association of That Perfusion Pattern and Therapeutic Efficacy of Antimuscarincs for Female Overactive Bladder Syndrome.

Primary Purpose

Lower Urinary Tract Symptoms

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Tolterodine SR
Sponsored by
Far Eastern Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Urinary Tract Symptoms focused on measuring LUTS

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • all cases are female patients with lower urinary tract symptoms

Exclusion Criteria:

  • nil

Sites / Locations

  • Far Eastern Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Bladder wall blood perfusion pattern

Arm Description

Outcomes

Primary Outcome Measures

Blood flow pattern after antimuscarinics

Secondary Outcome Measures

Blood flow patterns between different LUTS subgroups

Full Information

First Posted
January 23, 2011
Last Updated
January 11, 2019
Sponsor
Far Eastern Memorial Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01282840
Brief Title
Bladder Wall Blood Perfusion Pattern and Sexual Dysfunction in Female Patients With Lower Urinary Tract Symptoms, and the Association of That Perfusion Pattern and Therapeutic Efficacy of Antimuscarincs for Female Overactive Bladder Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 20, 2010 (Actual)
Primary Completion Date
November 5, 2018 (Actual)
Study Completion Date
December 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Far Eastern Memorial Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

5. Study Description

Brief Summary
Overactive bladder syndrome (OAB) affects around 17 % of female population. However, the etiology of OAB is complicated and unclear in many aspects. Bladder wall thickness had been reported to be strongly associated with OAB, but its use as a screening tool remains controversial. Besides, few studies reported patterns of sexual dysfunction in female patients with lower urinary tract symptoms (LUTS). Therefore the aims of our study were to analyze the bladder wall blood perfusion pattern in female LUTS patients, the association of between the bladder wall blood perfusion pattern and the efficacy of anti-muscarinic treatment for female OAB, and the patterns of sexual dysfunction in the female LUTS patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms
Keywords
LUTS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
676 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bladder wall blood perfusion pattern
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Tolterodine SR
Intervention Description
Tolterodine SR 4 mg qd
Primary Outcome Measure Information:
Title
Blood flow pattern after antimuscarinics
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Blood flow patterns between different LUTS subgroups
Time Frame
1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: all cases are female patients with lower urinary tract symptoms Exclusion Criteria: nil
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
New Taipei
State/Province
Banqiao
ZIP/Postal Code
22060
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Bladder Wall Blood Perfusion Pattern and Sexual Dysfunction in Female Patients With Lower Urinary Tract Symptoms, and the Association of That Perfusion Pattern and Therapeutic Efficacy of Antimuscarincs for Female Overactive Bladder Syndrome.

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