Female Pelvic Floor DysfunctionPFD POP UINCT02166528
The Study of Genes Localization for Female Pelvic Floor Dysfunction
An observational study of Female Pelvic Floor Dysfunction, run by Zhiqing, Liang at 1 site in China.
Trial summary
Female pelvic floor dysfunction (FPD) is due to defects in the pelvic support structures, degradation, damage or dysfunction. The main problem of which is pelvic organ prolapse(POP), urinary incontinence(UI) and genital tract injury. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Pelvic Floor Dysfunction
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Oct 2017
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The experiment group are patients with PFD. While the control group are volunteer patients without PFD on the basis of informed consent.
Who may be able to join
- female aging from 30 to 70-year old;
- preoperative diagnosis of gynecologic malignancies;
- have the ability to comply with Research programs;
- voluntarily participate in the study and signed an informed consent form
Who cannot join
- patients with severe cardiovascular diseases, kidney, liver and other vital organs diseases, bone marrow disease and mental illness;
- patients suffering from autoimmune diseases;
- patients with acute infectious disease or infection early phase of infection;
- patients with urinary tract infection;
- patients with infection or erosion of ano-genital skin;
- for any other reason, the researchers considered unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Obstetrics and Gynaecology, Southwest Hospital, Third Military
Chongqing, Chongqing Municipality, 400038
About this study
Official title: The Study of Susceptibility Genes Localization for Female Pelvic Floor Dysfunction
Female pelvic floor dysfunction (FPD) is due to defects in the pelvic support structures, degradation, damage or dysfunction. The main problem of which is pelvic organ prolapse(POP), urinary incontinence(UI) and genital tract injury. Although it does not pose a serious threat to life, but affect the patient's quality of life seriously in the physical, psychological, social behavior and other aspects. With the growing aging population, the incidence rate has gradually increased, and increasing demands for people's quality of life simultaneously, more and more attention was raised to PFD as common chronic diseases.
In recent years, the basic research, epidemiology, prevention, diagnosis and treatment of PFD have made great progress, especially in developing gynecological urology theory and reconstructive pelvic surgery. But overall the basic research of PFD is lagging behind, especially susceptibility gene localization and functional studies did not get enough attention.
- Conditions
- Female Pelvic Floor Dysfunction
- Keywords
- female pelvic floor dysfunction, pelvic organ prolaps, urinary incontinence, massively parallel sequencing
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| experiment group | patients with FPFD | |
| control group | patients without FPFD |
What is being measured
The primary outcome is the main question the study is designed to answer.
susceptibility genes localization
Based on high-throughput sequencing platform, we expect to screen out susceptibility genes location in PFD, providing theoretical basis for individualized prevention, intervention and treatment.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startNov 2013
- Primary completionOct 2016 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Pelvic Floor DysfunctionStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiqing, Liang
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Huada Genomics Co., Ltd.
- Responsible party
- Sponsor-investigator, Zhiqing, Liang, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166528
- Sponsor's protocol ID
- 002
- Acronym
- PFD POP UI
- Status last verified
- Jun 2014
- First submitted
- 10 Feb 2014
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Susceptibility Genes Localization for Female Pelvic Floor Dysfunction
- ClinicalTrials.gov ID
- NCT02166528
- Acronym / sponsor ID
- PFD POP UI / 002
- Conditions
- Female Pelvic Floor Dysfunction
- Keywords
- female pelvic floor dysfunction, pelvic organ prolaps, urinary incontinence, massively parallel sequencing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhiqing, LiangUniversity, hospital or other
- Collaborators
- Shenzhen Huada Genomics Co., Ltd.
- Study start
- Nov 2013
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 18 Jun 2014 (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.
Female pelvic floor dysfunction (FPD) is due to defects in the pelvic support structures, degradation, damage or dysfunction. The main problem of which is pelvic organ prolapse(POP), urinary incontinence(UI) and genital tract injury. Although it does not pose a serious threat to life, but affect the patient's quality of life seriously in the physical, psychological, social behavior and other aspects. With the growing aging population, the incidence rate has gradually increased, and increasing demands for people's quality of life simultaneously, more and more attention was raised to PFD as common chronic diseases.
In recent years, the basic research, epidemiology, prevention, diagnosis and treatment of PFD have made great progress, especially in developing gynecological urology theory and reconstructive pelvic surgery. But overall the basic research of PFD is lagging behind, especially susceptibility gene localization and functional studies did not get enough attention.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment group | – | –patients with FPFD |
| control group | – | –patients without FPFD |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The experiment group are patients with PFD. While the control group are volunteer patients without PFD on the basis of informed consent.
Key inclusion criteria (4 listed)
- female aging from 30 to 70-year old;
- preoperative diagnosis of gynecologic malignancies;
- have the ability to comply with Research programs;
- voluntarily participate in the study and signed an informed consent form
Key exclusion criteria (6 listed)
- patients with severe cardiovascular diseases, kidney, liver and other vital organs diseases, bone marrow disease and mental illness;
- patients suffering from autoimmune diseases;
- patients with acute infectious disease or infection early phase of infection;
- patients with urinary tract infection;
- patients with infection or erosion of ano-genital skin;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
susceptibility genes localization
Time frame: 4 years
Based on high-throughput sequencing platform, we expect to screen out susceptibility genes location in PFD, providing theoretical basis for individualized prevention, intervention and treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Pelvic Floor Dysfunction, run by Zhiqing, Liang at 1 site in China.
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 4 inclusion and 6 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 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
susceptibility genes localization (time frame: 4 years). 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 18 Jun 2014.