The Association of Pelvic Organ Prolapse Severity and Uri... | NCT01776580

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

NCT01776580

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Jan 26, 2016Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Pelvic Organ Prolapse
Sexual Dysfunction
Lower Urinary Tract Symptoms

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Jan 18, 2013

First Submission Date that Met QC Criteria

Jan 23, 2013

First Posted Date

Jan 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2016

Last Update Posted Date

Jan 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Label	Type	Description	Intervention Names
Lower urinary tract symptoms		Women with lower urinary tract symptoms

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the correlation of bladder descent and lower urinary tract symptoms.	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.	1 day

Secondary Outcomes

Measure	Description	Time Frame
To identify the correlation of bladder descent with sexual dysfunction.	To identify which parameters of sexual dysfunction is best correlated with the bladder descent.	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with lower urinary tract symptoms

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ho-Hsiung Lin, MD, PhD	Contact	+886-2-23123456	71557	hhlin@ntuh.gov.tw

Overall Officials

Name	Affiliation	Role
Ho-Hsiung Lin, MD, PhD	Department of Obstetrics & Gynecology, National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics & Gynecology, National Taiwan University Hospital	Recruiting	Taipei	Taiwan	100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D056887	Pelvic Organ Prolapse
D012735	Sexual Dysfunction, Physiological
D059411	Lower Urinary Tract Symptoms

Ancestor Terms

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D000091662	Genital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided