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Status unknownNCT02166528PFD POP UIUpdated Jun 18, 2014

The Study of Genes Localization for Female Pelvic Floor Dysfunction

An observational study in Female Pelvic Floor Dysfunction, sponsored by Zhiqing, Liang. Status unknown at 1 site in China. Open to female participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-18.

Sponsored by Zhiqing, Liang · Observational

The sponsor has not verified this record recently (last verified Jun 2014), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
30 Years to 70 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Female Pelvic Floor Dysfunction

Keywords

  • female pelvic floor dysfunction
  • pelvic organ prolaps
  • urinary incontinence
  • massively parallel sequencing
03

In context

Urinary Incontinence

1,375 studies on the registry are indexed under Urinary Incontinence; 224 are open to participants now.

This study's planned enrollment of 200 is above the median of 120 across 307 observational studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Zhiqing, Liang is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The experiment group are patients with PFD. While the control group are volunteer patients without PFD on the basis of informed consent.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. female aging from 30 to 70-year old;
  2. preoperative diagnosis of gynecologic malignancies;
  3. have the ability to comply with Research programs;
  4. voluntarily participate in the study and signed an informed consent form

Exclusion criteria

Exclusion Criteria:

  1. patients with severe cardiovascular diseases, kidney, liver and other vital organs diseases, bone marrow disease and mental illness;
  2. patients suffering from autoimmune diseases;
  3. patients with acute infectious disease or infection early phase of infection;
  4. patients with urinary tract infection;
  5. patients with infection or erosion of ano-genital skin;
  6. for any other reason, the researchers considered unsuitable for inclusion.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • experiment group

    patients with FPFD

  • control group

    patients without FPFD

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 years

07

Study locations

1 site
  • Department of Obstetrics and Gynaecology, Southwest Hospital, Third Military
    Chongqing, Chongqing Municipality 400038, China
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2013, a primary completion of Oct 2016 and a completion of Oct 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2014
First posted
Jun 18, 2014
Start
Nov 2013
Primary completionEst.
Oct 2016
CompletionEst.
Oct 2017
Last update
Jun 18, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02166528
Lead sponsor
Zhiqing, Liang
Collaborators
Shenzhen Huada Genomics Co., Ltd.
Responsible party
Zhiqing, Liang (Director of Obstetrics and Gynecology, Third Military Medical University) — Sponsor-investigator
First posted
Jun 18, 2014
Start date
Nov 2013
Primary completion
Oct 2016 (estimated)
Completion
Oct 2017 (estimated)
Last update
Jun 18, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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