The Study of Genes Localization for Female Pelvic Floor Dysfunction

NCT02166528 | Unknown DMC

• 1 other identifier: 002
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Female Pelvic Floor Dysfunction

Keywords

female pelvic floor dysfunction; pelvic organ prolaps; urinary incontinence; massively parallel sequencing

Outcome Measures

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.

  4 years

Study Arms (2)

experiment group

patients with FPFD

control group

patients without FPFD

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhiqing, Liang: lead
• Shenzhen Huada Genomics Co., Ltd.: collaborator

Study Sites (1)

Department of Obstetrics and Gynaecology, Southwest Hospital, Third Military

Chongqing, Chongqing Municipality, 400038, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

The sample of blood, urine, cervical exfoliated cells and tissue of patients with POP, UI or genital tract injury should be used only in this research with informed consent. The remaining part will be Safekeeping. All information is strictly confidential.

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: June 18, 2014
• Study Start: November 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2017
• Last Updated: June 18, 2014

Record last verified: 2014-06

Locations

CN (1)