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

• ClinicalTrials.gov Identifier: NCT02841059
• Recruitment Status: Unknown
• First Posted: July 21, 2016
• Last Update Posted: February 23, 2017
• Sponsor: Buddhist Tzu Chi General Hospital
• Collaborator: Ministry of Science and Technology, Taiwan
• Information provided by (Responsible Party): Buddhist Tzu Chi General Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Quality of Life; Urinary Incontinence; Pelvic Organ Prolapse	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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 120 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Target Follow-Up Duration: 2 Years
• 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
• Study Start Date: May 2015
• Estimated Primary Completion Date: June 2017
• Estimated Study Completion Date: June 2018

Groups and Cohorts

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 Name: 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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

Contacts and Locations

Locations

Taiwan

Dalin Tzu Chi Hospital

Chiayi, Taiwan, 62224

Buddhist Tzu Chi General Hospital

Hualien, Taiwan, 970

Mennonite Memorial Hospital

Hualien, Taiwan, 970

Taipei Tzu Chi Hospital

Taipei, Taiwan, 23142

Sponsors and Collaborators

Buddhist Tzu Chi General Hospital

Ministry of Science and Technology, Taiwan

Investigators

• Principal Investigator: Mun-Kun Hong, MD; Department of Obstetrics and Gynecology

More Information

Additional Information:

• Responsible Party: Buddhist Tzu Chi General Hospital
• ClinicalTrials.gov Identifier: NCT02841059
• Other Study ID Numbers: HYS-SEX-QOL-POP
• First Posted: July 21, 2016
• Last Update Posted: February 23, 2017
• Last Verified: July 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Buddhist Tzu Chi General Hospital:

quality of life; urinary incontinence; POP

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Prolapse; Pelvic Organ Prolapse; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders; Pathological Conditions, Anatomical