The Pelvic Floor Function and Sexual Life of the Women After Different Type of Hysterectomy

Quality of Life Clinical Trial

— HYS-PF-QOL  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02841059
• Other study ID #: HYS-SEX-QOL-POP
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 20, 2016
• Last updated: February 22, 2017
• Start date: May 2015
• Est. completion date: June 2018

Study information

• Verified date: July 2016
• Source: Buddhist Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Pelvic Organ Prolapse
• Prolapse
• Quality of Life
• Urinary Incontinence

Intervention

Procedure:
• LSH
laparoscopic subtotal hysterectomy: LSH
• CLSH
laparoscopic cervical ligament sparing hysterectomy: CLSH
• LAVH
laparoscopic assisted vaginal hysterectomy: LAVH

Locations

Country	Name	City	State
Taiwan	Dalin Tzu Chi Hospital	Chiayi
Taiwan	Buddhist Tzu Chi General Hospital	Hualien
Taiwan	Mennonite Memorial Hospital	Hualien
Taiwan	Taipei Tzu Chi Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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