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The Association of Pelvic Organ Prolapse Severity and Urinary Symptoms and Sexual Function

This study is currently recruiting participants.
Verified January 2016 by National Taiwan University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01776580
First Posted: January 28, 2013
Last Update Posted: January 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose
Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. Therefore, the aim of this study is to identify the above associations by perineal sonography.

Condition
Pelvic Organ Prolapse Sexual Dysfunction Lower Urinary Tract Symptoms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Association of Pelvic Organ Prolapse Severity and Urinary Symptoms and Sexual Function

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • To assess the correlation of bladder descent and lower urinary tract symptoms. [ Time Frame: 1 day ]
    To assess the correlation of bladder descent and lower urinary tract symptoms, and identify which symptoms is best correlated with bladder descent during Valsalva maneuver.


Secondary Outcome Measures:
  • To identify the correlation of bladder descent with sexual dysfunction. [ Time Frame: 1 year ]
    To identify which parameters of sexual dysfunction is best correlated with the bladder descent.


Estimated Enrollment: 1000
Study Start Date: July 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lower urinary tract symptoms
Women with lower urinary tract symptoms

Detailed Description:
Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. Therefore, the aim of this study is to identify the above associations by perineal sonography.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with lower urinary tract symptoms
Criteria

Inclusion Criteria:

  • all patients with lower urinary tract symptoms and will undergo urodynamic studies

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

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): NCT01776580


Contacts
Contact: Ho-Hsiung Lin, MD, PhD +886-2-23123456 ext 71557 hhlin@ntuh.gov.tw

Locations
Taiwan
Department of Obstetrics & Gynecology, National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Ho-Hsiung Lin, MD, PhD    +886-2-23123456 ext 71557    hhlin@ntuh.gov.tw   
Principal Investigator: Ho-Hsiung Lin, MD,PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ho-Hsiung Lin, MD, PhD Department of Obstetrics & Gynecology, National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01776580     History of Changes
Other Study ID Numbers: 201107060RC
First Submitted: January 18, 2013
First Posted: January 28, 2013
Last Update Posted: January 26, 2016
Last Verified: January 2016

Keywords provided by National Taiwan University Hospital:
Pelvic organ prolapse
lower urinary tract symptoms
sexual dysfunction

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Lower Urinary Tract Symptoms
Pathological Conditions, Anatomical
Urological Manifestations
Signs and Symptoms