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
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Condition or disease | Intervention/treatment |
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Quality of Life Urinary Incontinence Pelvic Organ Prolapse | Procedure: LSH Procedure: CLSH Procedure: LAVH |
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 |

Group/Cohort | Intervention/treatment |
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Laparoscopic subtotal hysterectomy
women with benign gynecology disease and decided to receive laparoscopic subtotal hysterectomy (LSH) after discussion with her surgeon.
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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.
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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.
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Procedure: LAVH
laparoscopic assisted vaginal hysterectomy: LAVH |
- 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.
- 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.
- 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.
- 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.
- 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.

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

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
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 |
Principal Investigator: | Mun-Kun Hong, MD | Department of Obstetrics and Gynecology |
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 |
quality of life urinary incontinence POP |
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 |