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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.

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 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: November 13, 2013
Last verified: November 2013
  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:


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 2014
Estimated Primary Completion Date: June 2014 (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:

  • nil
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 13, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Far Eastern Memorial Hospital:
LUTS

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

ClinicalTrials.gov processed this record on November 25, 2014