NCT01683890

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

4.8 years

First QC Date

September 4, 2012

Last Update Submit

May 27, 2017

Conditions

Benign Uterine Disease

Keywords

Bladder symptomsSexual functionQuality of lifeSimple hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Incidence of bladder symptoms

    within 6 months after surgery

Secondary Outcomes (3)

  • Pattern change of bladder symptoms after surgery

    Baseline and within 6 months after surgery

  • Sexual function change

    Baseline and within 6 months after surgery

  • Quality of life

    within 6 months aftr surgery

Study Arms (1)

Simple hysterectomy group

Patients will undergo simple hysterectomy due to benign uterine disease.

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, 138-736, South Korea

Location

Study Officials

  • Hee-Dong Chae, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 12, 2012

Study Start

September 1, 2012

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

KR(1)