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

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ClinicalTrials.gov Identifier: NCT01776580
Recruitment Status : Unknown
Verified January 2016 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : January 28, 2013
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date January 18, 2013
First Posted Date January 28, 2013
Last Update Posted Date January 26, 2016
Study Start Date July 2011
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 2, 2014)
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.
Original Primary Outcome Measures
 (submitted: January 23, 2013)
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 Vulsalva maneuver.
Change History Complete list of historical versions of study NCT01776580 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 23, 2013)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Association of Pelvic Organ Prolapse Severity and Urinary Symptoms and Sexual Function
Official Title The Association of Pelvic Organ Prolapse Severity and Urinary Symptoms and Sexual Function
Brief Summary 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with lower urinary tract symptoms
Condition
  • Pelvic Organ Prolapse
  • Sexual Dysfunction
  • Lower Urinary Tract Symptoms
Intervention Not Provided
Study Groups/Cohorts Lower urinary tract symptoms
Women with lower urinary tract symptoms
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 22, 2013)
1000
Original Estimated Enrollment
 (submitted: January 23, 2013)
500
Estimated Study Completion Date December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01776580
Other Study ID Numbers 201107060RC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Ho-Hsiung Lin, MD, PhD Department of Obstetrics & Gynecology, National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date January 2016