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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.

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ClinicalTrials.gov Identifier: NCT01282840
Recruitment Status : Recruiting
First Posted : January 25, 2011
Last Update Posted : September 7, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Lower Urinary Tract Symptoms Drug: Tolterodine SR

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2010
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Bladder wall blood perfusion pattern Drug: Tolterodine SR
Tolterodine SR 4 mg qd

Outcome Measures

Primary Outcome Measures :
  1. Blood flow pattern after antimuscarinics [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Blood flow patterns between different LUTS subgroups [ Time Frame: 1 day ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • all cases are female patients with lower urinary tract symptoms

Exclusion Criteria:

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282840

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

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
First Posted: January 25, 2011    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016

Keywords provided by Sheng-Mou Hsiao, Far Eastern Memorial Hospital:

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tolterodine Tartrate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents