Serial Changes in Micturition Symptoms, Urine Flow and Bl... | NCT02242422

Studies
Serial Changes in Micturition Symptoms, Urine Flow and Bladder Voiding Efficiency Following Transobturator Tape Surgery

NCT02242422

Sponsor

DongGuk University

Status

Unknown status

Last Update Posted

Sep 17, 2014Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Stress Urinary Incontinence

Interventions

Not provided

Countries

South Korea

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

Sep 2014

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

Aug 2014

Primary Completion Date

Nov 2014Estimated

Completion Date

Not provided

First Submitted Date

Sep 14, 2014

First Submission Date that Met QC Criteria

Sep 15, 2014

First Posted Date

Sep 17, 2014Estimated

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

Sep 15, 2014

Last Update Posted Date

Sep 17, 2014Estimated

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

The aim of this study was to identify the serial changes in lower urinary tract symptoms (LUTS), urine flow and bladder voiding efficiency after transobturator tape (TOT) surgery for treatment of female stress urinary incontinence.

Detailed Description

Not provided

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

200Estimated

Label	Type	Description	Intervention Names
transobturator tape

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in total overactive bladder symptom score (OABSS) after surgery		1-week, and 1-, 3-, 6- and 12-months after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women who underwent transobturator tape surgery for treatment of female stress urinary incontinence

Exclusion Criteria:

any urinary tract infection
pregnancy
bladder malignancy
postoperative follow-up of less than 12 months

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

women who underwent transobturator tape surgery for treatment of female stress urinary incontinence

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Min Chul Cho, M.D., Ph.D.	Contact	82-31-961-7456	7456	cmc1206@empal.com

Overall Officials

Name	Affiliation	Role
Min Chul Cho, M.D., Ph.D.	DongGuk University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dongguk University ilsan Hospital	Recruiting	Goyang-si	Gyeonggi-do	410-773	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D014550	Urinary Incontinence, Stress

Ancestor Terms

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided