Patients With Chronic Pelvic Pain With Vaginal Microbiota

Pelvic Pain Clinical Trial

Official title:

Chronic Pelvic Pain With Vaginal Microbiota in Gestational Women Without HPV Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03786588
• Other study ID #: CPPVM
• Status: Recruiting
• Start date: December 25, 2018
• Est. completion date: December 25, 2020

Study information

• Verified date: August 2019
• Source: Peking Union Medical College Hospital
• Contact: Shu Wang
• Phone: +86-18810535568
• Email: chaoxp_pumch[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Vaginal microorganisms play an important role in the occurrence and development of many diseases, such as persistent infection of high-risk human papillomavirus (HR-HPV) causing cervical intraepithelial neoplasia and cervical cancer, and the role of microorganisms in chronic prostatitis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: December 25, 2020
• Est. primary completion date: December 25, 2019
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Those are aged 20 to 45 years old, have vaginal intercourse more than 3 years, and aren't in menstrual, pregnancy or puerperium period.

Exclusion Criteria:

• Those are aged more than 45 years old without HPV infection in the last one year, having no vaginal intercourse, and those can't cooperate the examiner. Women who are HIV or hepatitis B/C positive, have autoimmune disorders and systemic disease (like diabetes mellitus, hormone treatment diseases, severe liver and kidney dysfunction), or have severe mental illness and malignant tumors are also excluded. At the same time, all the participants should meet the following requirements: no vagina douching within last 2 days, no vaginal intercourse within last 3 days, no systemic application of antifungal agents or antibiotics or pessaries within last 14 days of sampling.

Related Conditions & MeSH terms

• Pelvic Pain

Intervention

Other:
• Observation
The patients with the negative results of HPV infection, and assigned to different group according to the CPP manifestation.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal microbiota difference	Vaginal microbiota difference between the women with or without CPP, and all the cases are cervical HPV negative.	one year