Clinical trial NCT02841059: The Pelvic Floor Function and Sexual Life of the Women After Different Type of Hysterectomy
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Urinary Incontinence
Pelvic Organ Prolapse
Keywords: quality of life
urinary incontinence
POP
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2016-07-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Quality of life change
timeFrame: up to 12 months after hysterectomy
Secondary outcomes:
measure: Pelvic organ prolapse change
timeFrame: up to 24 months after hysterectomy
measure: Urinary disorders change
timeFrame: preoperation and 3,6 and 12 months after hysterectomy
measure: Sexual life change
timeFrame: preoperation and 3,6 and 12 months after hysterectomy
measure: Urinary incontinence status change
timeFrame: preoperation and 3,6 and 12 months after hysterectomy
Other outcomes:
Locations:
city: Chiayi
country: Taiwan
facility: Dalin Tzu Chi Hospital
city: Hualien
country: Taiwan
facility: Buddhist Tzu Chi General Hospital
city: Hualien
country: Taiwan
facility: Mennonite Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Tzu Chi Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology
name: Mun-Kun Hong, MD
role: PRINCIPAL_INVESTIGATOR
References: