Nonneoplastic Epithelial Disorders of Vulva and High Intensity Focused Ultrasound

NCT ID: NCT02890277

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-12-31

Brief Summary

Nonneoplastic epithelial disorders of skin and mucosa of vulva refer to a group of chronic diseases shown as female genital skin and mucosal tissue degeneration and pigmentation change. The main symptoms are vulval itching, squamous cell hyperplasia, vulval and perianal skin atrophy or thinning, hypopigmentation. The current treatments are primarily local drug or surgical treatments. However, the effect is not good enough, but the diseases often recur and severely affect patients' quality of life. In this study, the investigators combined the technology of high intensity focused ultrasound (HIFU) (ultrasound device made by Mianyang Sonic electronic LLC, Mianyang China, registration number: 2005-2230099} with special drug to treat. The data from colposcopy and biopsy pathology were collected before and after treatment to create the objective identifying degree of the disease by with "grading methods" and evaluate the treatment effect. At the meantime, the standardized treatment procedure, methods and efficacy criterion were all stipulated to achieve satisfactory results, which could be used to clinical treatments. So far, the investigators have not seen similar study reported internationally.

Conditions

Vulva Intraepithelial Nonneoplastic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Group Type: EXPERIMENTAL

the high intensity focused ultrasound (Mianyang Sonic electronic LLC)

Intervention Type: DEVICE

Fu Tiankang disposable vaginal filling suppository, Albothyl (Policresulen Solution) , and the gynecologic medical antimicrobial dressing gel (chitosan gel).

Intervention Type: DRUG

Interventions

the high intensity focused ultrasound (Mianyang Sonic electronic LLC)

Intervention Type: DEVICE

Fu Tiankang disposable vaginal filling suppository, Albothyl (Policresulen Solution) , and the gynecologic medical antimicrobial dressing gel (chitosan gel).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients with clinically and biopsy confirmed non-neoplastic lesions of genital skin and mucous membrane (non-neoplasia epithelial disorders of skin and mucosa of vulva).

Symptoms include repeated itching, discoloration, rhagades, loss of skin elasticity and dyspareunia that affect the patients' quality of life.

Exclusion Criteria

• atypical hyperplasia or vulvar cancer confirmed by biopsy of genital lesions;
• vulvovaginal or other gynecological trauma, acute inflammatory diseases and other acute illness in need of urgent care;
• combined with other serious gynecological diseases (symptomatic hysteromyoma, ovarian tumor, etc.), and/or severe organ diseases (such as heart, lung, brain and renal disease/failure) that need immediate treatment;
• other type of cancers that require urgent care.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jinan Military General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Geping Yin

Professor/Surgeon,Leader of Department of Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jinan Military General Hospital

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Geping Yin, M.D.

Role: CONTACT

ygpwylll@hotmail.com

86-0531-51666230

Facility Contacts

Geping Yin, M.D.

Role: primary

ygpwylll@hotmail.com

86-0531-51666230

Other Identifiers

JNJQ201408

Identifier Type: -

Identifier Source: org_study_id