The Pelvic Floor Function and Sexual Life of the Women After Different Type of Hysterectomy (HYS-PF-QOL)

The Association of Total Hysterectomy and Disorders of Female Pelvic Floor or Sexual Function: a Survey on Pelvic Floor Function and Sexual Life for Women After Different Type of Hysterectomy

In this prospective, comparative non-randomized multiple teaching hospitals study, the investigators try to determine the relationship of total hysterectomy and Taiwanese female pelvic floor and sexual function from the view of epidemiology and clinical survey. This is an important issue that related to female autonomy, health care resources and even national health policy. The study results will help to understand whether there is unnecessary part in the current hysterectomy procedures and its potential health hazard.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Urinary Incontinence; Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: LSH; Procedure: CLSH; Procedure: LAVH

Detailed Description

Women with benign gynecology disease and indicated for laparoscopic hysterectomy (laparoscopic subtotal hysterectomy: LSH, laparoscopic cervical ligament sparing hysterectomy: CLSH, laparoscopic assisted vaginal hysterectomy: LAVH) are invited and explained the details of the protocol by the surgeon. The types of hysterectomy are determined by the patient and the surgeon together after discussion. All participant have to sign the informed consent. The participant will be followed up for two years after surgery. Preoperative evaluation on uterine condition, pelvic floor, questionaires were recorded. The perioperative parameters including surgical time, blood loss, and postoperative parameters such as pain score, hospitalization etc were recorded. The postoperative evaluation on pelvic floor condition, questionaires etc were also recorded at different time points.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Taiwan
  • Chiayi, Taiwan, 62224
    • Dalin Tzu Chi Hospital
  • Hualien, Taiwan, 970
    • Buddhist Tzu Chi General Hospital
  • Hualien, Taiwan, 970
    • Mennonite Memorial Hospital
  • Taipei, Taiwan, 23142
    • Taipei Tzu Chi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patient who is indicated for hysterectomy due to benign gynecology disease. The participant's husband is also welcomed to join the survey of the sexual life questionnaire but this is not a necessary inclusion criteria.

Description

Inclusion Criteria:

1. Patient who is indicated for hysterectomy due to benign gynecology disease. The participant's husband is also welcomed to join the survey of the sexual life questionnaire but this is not a necessary inclusion criteria.

Exclusion Criteria:

1. Suspect of or diagnosed as cancer patient
2. Age < 30 or > 50 years old
3. Menopausal woman or woman who is nulliparous
4. Patient with advanced pelvic floor prolapse (stage 2, 3, 4) including uterine prolapse, cystocele, enterocele, rectocele.
5. Patient with prominent urinary incontinence that affect social activity or suggested to have surgery by gynecologist or urologist.
6. Patient with severe medical diseases such as liver cirrhosis, heart failure, poor control diabetes mellitus etc.
7. Patient with severe pelvic inflammatory disease/tubo-ovarian abcess or pelvic endometriosis or history of severe pelvic adhesions.
8. Psychiatric patients
9. Patient with chronic lung disease such as bronchial asthma, bronchiectasis, chronic obstructive pulmonary disease and interstitial lung disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laparoscopic subtotal hysterectomy; women with benign gynecology disease and decided to receive laparoscopic subtotal hysterectomy (LSH) after discussion with her surgeon.	Procedure: LSH; laparoscopic subtotal hysterectomy: LSH; Other Names: laparoscopic subtotal hysterectomy: LSH
Laparoscopic CLSH; women with benign gynecology disease and decided to receive laparoscopic cervical ligament sparing hysterectomy (CLSH) after discussion with her surgeon.	Procedure: CLSH; laparoscopic cervical ligament sparing hysterectomy: CLSH
Laparoscopic AVH; women with benign gynecology disease and decided to receive laparoscopic assisted vaginal hysterectomy (LAVH) after discussion with her surgeon.	Procedure: LAVH; laparoscopic assisted vaginal hysterectomy: LAVH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life change	Evaluate the change of quality of life by questionaire --WHOQOL-BREF Taiwan version, at preoperation,1,3,6 and 12 months after hysterectomy.	up to 12 months after hysterectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic organ prolapse change	evaluate by Pelvic Organ Prolapse Quantification System (POP-Q) at preoperation, 6,12 and 24 months after hysterectomy.	up to 24 months after hysterectomy
Urinary disorders change	evaluate by UDI-6 short form at preoperation,3,6 and 12 months after hysterectomy.	preoperation and 3,6 and 12 months after hysterectomy
Sexual life change	short form of PISQ-9 approved by International Urogynecological Association, IUGA, at preoperation,3,6 and 12 months after hysterectomy.	preoperation and 3,6 and 12 months after hysterectomy
Urinary incontinence status change	evaluate by IIQ-7 short form at preoperation,3,6 and 12 months after hysterectomy.	preoperation and 3,6 and 12 months after hysterectomy

Collaborators and Investigators

• Sponsor: Buddhist Tzu Chi General Hospital
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: Mun-Kun Hong, MD, Department of Obstetrics and gynecology

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: July 19, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: quality of life; urinary incontinence; POP
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Elimination Disorders; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Enuresis
• Other Study ID Numbers: HYS-SEX-QOL-POP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided