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.

This study is currently recruiting participants.

Verified March 2013 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:

NCT01282840

First received: January 23, 2011

Last updated: March 27, 2013

Last verified: March 2013

History of Changes

Purpose

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.

Condition	Intervention
Lower Urinary Tract Symptoms	Drug: Tolterodine SR

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Tolterodine Tolterodine tartrate

U.S. FDA Resources

Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:

Blood flow pattern after antimuscarinics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood flow patterns between different LUTS subgroups [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	July 2010
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Bladder wall blood perfusion pattern	Drug: Tolterodine SR Tolterodine SR 4 mg qd

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

all cases are female patients with lower urinary tract symptoms

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282840

Locations

Taiwan
Far Eastern Memorial Hospital	Recruiting
Pan-Chiao, Taiwan
Contact: Hsiao Sheng Mou, MD +886-2-89667000 ext 124 smhsiao2@gmail.com

Sponsors and Collaborators

Far Eastern Memorial Hospital

National Science Council, Taiwan

More Information

No publications provided

Responsible Party:	Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:	NCT01282840 History of Changes
Other Study ID Numbers:	099049-F
Study First Received:	January 23, 2011
Last Updated:	March 27, 2013
Health Authority:	Taiwan: Institutional Review Board

Keywords provided by Far Eastern Memorial Hospital:

LUTS

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Tolterodine
Muscarinic Antagonists

Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013

To Top