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

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

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




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841059


Locations
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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
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Principal Investigator: Mun-Kun Hong, MD Department of Obstetrics and Gynecology
Additional Information:

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Responsible Party: Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT02841059    
Other Study ID Numbers: HYS-SEX-QOL-POP
First Posted: July 21, 2016    Key Record Dates
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:
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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