The Study of Genes Localization for Female Pelvic Floor Dysfunction (PFD POP UI)

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.

Study Overview

• Status: Unknown
• Conditions: Female Pelvic Floor Dysfunction

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Department of Obstetrics and Gynaecology, Southwest Hospital, Third Military

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
experiment group; patients with FPFD
control group; patients without FPFD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 years

Collaborators and Investigators

• Sponsor: Zhiqing, Liang
• Collaborators: Shenzhen Huada Genomics Co., Ltd.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: February 10, 2014
• First Submitted That Met QC Criteria: June 14, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Estimate): June 18, 2014
• Last Update Submitted That Met QC Criteria: June 14, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: urinary incontinence; female pelvic floor dysfunction; pelvic organ prolaps; massively parallel sequencing
• Other Study ID Numbers: 002 (University of CT Health Center)