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Status unknownNCT01683890Updated May 31, 2017

Study on Bladder and Sexual Function Change After Simple Hysterectomy

An observational study in Benign Uterine Disease, sponsored by Asan Medical Center. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-05-31.

Sponsored by Asan Medical Center · Observational

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
20 Years to 80 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Benign Uterine Disease

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Keywords

  • Bladder symptoms
  • Sexual function
  • Quality of life
  • Simple hysterectomy
03

In context

Uterine Diseases

66 studies on the registry are indexed under Uterine Diseases; 8 are open to participants now.

This study's planned enrollment of 300 is above the median of 168 across 12 observational studies indexed under Uterine Diseases.

Browse Uterine Diseases studies →

Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)

Groups and cohorts

  • Simple hysterectomy group

    Patients will undergo simple hysterectomy due to benign uterine disease.

06

What researchers measure

Primary outcomes

  1. Incidence of bladder symptoms

    Time frame: within 6 months after surgery

Secondary outcomes

  1. Pattern change of bladder symptoms after surgery

    Time frame: Baseline and within 6 months after surgery

  2. Sexual function change

    Time frame: Baseline and within 6 months after surgery

  3. Quality of life

    Time frame: within 6 months aftr surgery

07

Study locations

1 site
  • Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
    Seoul, 138-736, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01683890
Lead sponsor
Asan Medical Center
Collaborators
Astellas Pharma Inc
Responsible party
Hee-Dong Chae (Professor, Asan Medical Center) — Principal investigator
First posted
Sep 12, 2012
Start date
Sep 2012
Primary completion
Jul 2017 (estimated)
Completion
Jul 2017 (estimated)
Last update
May 31, 2017

Study contacts

Hee-Dong Chae, M.D., Ph.D.
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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