Pelvic Organ Prolapse, Quality of Life, Urinary Incontinence
Conditions
Keywords
quality of life, urinary incontinence, POP
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.
Interventions
PROCEDURELSH
laparoscopic subtotal hysterectomy: LSH
PROCEDURECLSH
laparoscopic cervical ligament sparing hysterectomy: CLSH
PROCEDURELAVH
laparoscopic assisted vaginal hysterectomy: LAVH
Sponsors
Ministry of Science and Technology, Taiwan
Buddhist Tzu Chi General Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life change | 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
| Measure | Time frame | Description |
|---|---|---|
| Pelvic organ prolapse change | 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 | 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 | 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 | preoperation and 3,6 and 12 months after hysterectomy | evaluate by IIQ-7 short form at preoperation,3,6 and 12 months after hysterectomy. |
Countries
Taiwan
Outcome results
None listed