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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 2013 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01776580
First received: January 18, 2013
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  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 Dysfunction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    To assess the correlation of bladder descent and lower urinary tract symptoms, and identify which symptoms is best correlated with bladder descent during Vulsalva maneuver.


Secondary Outcome Measures:
  • To identify the correlation of bladder descent with sexual dysfunction. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To identify which parameters of sexual dysfunction is best correlated with the bladder descent.


Estimated Enrollment: 500
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lower urinary tract symptoms
Women with lower urinary tract symptoms

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders 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:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: National Taiwan University Hospital, Ho-Hsiung Lin, Professor of Department of Obstetrics & Gynecology
ClinicalTrials.gov Identifier: NCT01776580     History of Changes
Other Study ID Numbers: 201107060RC
Study First Received: January 18, 2013
Last Updated: January 23, 2013
Health Authority: Taiwan: Institutional Review Board

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

Additional relevant MeSH terms:
Prolapse
Sexual Dysfunctions, Psychological
Pelvic Organ Prolapse
 Pathological Conditions, Anatomical
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013