NCT01282840

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
676

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

July 20, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2018

Completed
Last Updated

January 15, 2019

Status Verified

November 1, 2018

Enrollment Period

8.3 years

First QC Date

January 23, 2011

Last Update Submit

January 11, 2019

Conditions

Lower Urinary Tract Symptoms

Keywords

LUTS

Outcome Measures

Primary Outcomes (1)

  • Blood flow pattern after antimuscarinics

    12 weeks

Secondary Outcomes (1)

  • Blood flow patterns between different LUTS subgroups

    1 day

Study Arms (1)

Bladder wall blood perfusion pattern

OTHER
Drug: Tolterodine SR

Interventions

Tolterodine SRDRUG

Tolterodine SR 4 mg qd

Bladder wall blood perfusion pattern

Eligibility Criteria

Age20 Years - 99 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all cases are female patients with lower urinary tract symptoms

You may not qualify if:

  • nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Banqiao, 22060, Taiwan

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

January 23, 2011

First Posted

January 25, 2011

Study Start

July 20, 2010

Primary Completion

November 5, 2018

Study Completion

December 26, 2018

Last Updated

January 15, 2019

Record last verified: 2018-11

Locations

TW(1)