Study on Bladder and Sexual Function Change After Simple... | NCT01683890

Studies
Study on Bladder and Sexual Function Change After Simple Hysterectomy

NCT01683890

Sponsor

Asan Medical Center

Status

Unknown status

Last Update Posted

May 31, 2017Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Benign Uterine Disease

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

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Jul 2017Estimated

Completion Date

Jul 2017Estimated

First Submitted Date

Sep 4, 2012

First Submission Date that Met QC Criteria

Sep 8, 2012

First Posted Date

Sep 12, 2012Estimated

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

May 27, 2017

Last Update Posted Date

May 31, 2017Actual

Name	Class
Astellas Pharma Inc	INDUSTRY

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

To evaluate the incidence and pattern of bladder symptoms and sexual function change occuring after simple hysterectomy and to analyze the influence of bladder symptoms and sexual function change on quality of life of patients.

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

Not provided

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

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Simple hysterectomy group		Patients will undergo simple hysterectomy due to benign uterine disease.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of bladder symptoms		within 6 months after surgery

Secondary Outcomes

Measure	Description	Time Frame
Pattern change of bladder symptoms after surgery		Baseline and within 6 months after surgery
Sexual function change		Baseline and within 6 months after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who is planed to undergo simple hysterectomy due to benign uterine disease
1. Uterine leiomyoma
2. Uterine adenomyosis
3. Endometrial hyperplasia
4. Cervical intraepithelial neoplasia (including carcinoma in situ, FIGO stage IA1 cancer)
5. Dysfunctional uterine bleeding
6. Other benign uterine disease requiring hysterectomy

Exclusion Criteria:

Patients who are taking medication for overactive bladder
Patients who underwent incontinence surgery due to urinary incontinence
Acute or chronic infectious disease of urinary tract
Neurologic disease causing urinary abnormality
Previous pelvic radiation therapy
Patients who are undergoing incontinence surgery with hysterectomy
Pregnant woman

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patinets who undergo simple hysterectomy due to benign uterine disease at university hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hee-Dong Chae, M.D., Ph.D.	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center		Seoul		138-736	South Korea