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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02166528
Other study ID # 002
Secondary ID
Status Enrolling by invitation
Phase N/A
First received February 10, 2014
Last updated June 14, 2014
Start date November 2013
Est. completion date October 2017

Study information

Verified date June 2014
Source Third Military Medical University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date October 2017
Est. primary completion date October 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 70 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
China Department of Obstetrics and Gynaecology, Southwest Hospital, Third Military Chongqing Chongqing

Sponsors (2)

Lead Sponsor Collaborator
Zhiqing, Liang Shenzhen Huada Genomics Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No