Quality of LifeHYS-PF-QOLNCT02841059
The Pelvic Floor Function and Sexual Life of the Women After Different Type of Hysterectomy
An observational study of Quality of Life and Urinary Incontinence, run by Buddhist Tzu Chi General Hospital at 4 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Quality of Life, Urinary Incontinence, Pelvic Organ Prolapse
- What is being tested?
- LSH, CLSH and LAVH
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 4 sitesTaiwan
- Study dates
- May 2015to Jun 2018
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Dalin Tzu Chi Hospital
Chiayi City, Chiayi, 62224
Buddhist Tzu Chi General Hospital
Hualien City, Hualien, 970
Mennonite Memorial Hospital
Hualien City, Hualien, 970
Taipei Tzu Chi Hospital
Taipei, Taipei, 23142
About this study
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
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.
Read the 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.
- Conditions
- Quality of Life, Urinary Incontinence, Pelvic Organ Prolapse
- Being tested
- LSH, CLSH, LAVH
- Keywords
- quality of life, urinary incontinence, POP
- Medical subject headings
- Urinary Incontinence, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSHProcedure or surgery
Also called laparoscopic subtotal hysterectomy: LSH
laparoscopic subtotal hysterectomy: LSH
CLSHProcedure or surgery
laparoscopic cervical ligament sparing hysterectomy: CLSH
LAVHProcedure or surgery
laparoscopic assisted vaginal hysterectomy: LAVH
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic subtotal hysterectomy | women with benign gynecology disease and decided to receive laparoscopic subtotal hysterectomy (LSH) after discussion with her surgeon. Receives: Procedure: LSH | |
| Laparoscopic CLSH | women with benign gynecology disease and decided to receive laparoscopic cervical ligament sparing hysterectomy (CLSH) after discussion with her surgeon. Receives: Procedure: CLSH | |
| Laparoscopic AVH | women with benign gynecology disease and decided to receive laparoscopic assisted vaginal hysterectomy (LAVH) after discussion with her surgeon. Receives: Procedure: LAVH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life change
Evaluate the change of quality of life by questionaire --WHOQOL-BREF Taiwan version, at preoperation,1,3,6 and 12 months after hysterectomy.
Measured: up to 12 months after hysterectomy
Secondary outcomes (4)
Pelvic organ prolapse change
evaluate by Pelvic Organ Prolapse Quantification System (POP-Q) at preoperation, 6,12 and 24 months after hysterectomy.
Measured: up to 24 months after hysterectomy
Urinary disorders change
evaluate by UDI-6 short form at preoperation,3,6 and 12 months after hysterectomy.
Measured: preoperation and 3,6 and 12 months after hysterectomy
Sexual life change
short form of PISQ-9 approved by International Urogynecological Association, IUGA, at preoperation,3,6 and 12 months after hysterectomy.
Measured: preoperation and 3,6 and 12 months after hysterectomy
Urinary incontinence status change
evaluate by IIQ-7 short form at preoperation,3,6 and 12 months after hysterectomy.
Measured: preoperation and 3,6 and 12 months after hysterectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startMay 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Mun-Kun Hong, MD, Principal investigator, Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841059
- Sponsor's protocol ID
- HYS-SEX-QOL-POP
- Acronym
- HYS-PF-QOL
- Status last verified
- Jul 2016
- First submitted
- 20 Jun 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02841059
- Acronym / sponsor ID
- HYS-PF-QOL / HYS-SEX-QOL-POP
- Conditions
- Quality of Life, Urinary Incontinence, Pelvic Organ Prolapse
- Keywords
- quality of life, urinary incontinence, POP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- May 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic subtotal hysterectomy | – | Procedure: LSHwomen with benign gynecology disease and decided to receive laparoscopic subtotal hysterectomy (LSH) after discussion with her surgeon. |
| Laparoscopic CLSH | – | Procedure: CLSHwomen with benign gynecology disease and decided to receive laparoscopic cervical ligament sparing hysterectomy (CLSH) after discussion with her surgeon. |
| Laparoscopic AVH | – | Procedure: LAVHwomen with benign gynecology disease and decided to receive laparoscopic assisted vaginal hysterectomy (LAVH) after discussion with her surgeon. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSHAlso: laparoscopic subtotal hysterectomy: LSHlaparoscopic subtotal hysterectomy: LSH | Procedure or surgery | Laparoscopic subtotal hysterectomy |
| CLSHlaparoscopic cervical ligament sparing hysterectomy: CLSH | Procedure or surgery | Laparoscopic CLSH |
| LAVHlaparoscopic assisted vaginal hysterectomy: LAVH | Procedure or surgery | Laparoscopic AVH |
Primary outcome
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.
4 secondary outcomes
Pelvic organ prolapse change
Time frame: up to 24 months after hysterectomy
Urinary disorders change
Time frame: preoperation and 3,6 and 12 months after hysterectomy
Sexual life change
Time frame: preoperation and 3,6 and 12 months after hysterectomy
Urinary incontinence status change
Time frame: preoperation and 3,6 and 12 months after hysterectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mun-Kun Hong, MD principal investigator
Department of Obstetrics and Gynecology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Urinary Incontinence, run by Buddhist Tzu Chi General Hospital at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life change (time frame: up to 12 months after hysterectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.