Vulva Intraepithelial Nonneoplastic
Conditions
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.
Interventions
DEVICEthe high intensity focused ultrasound (Mianyang Sonic electronic LLC)
DRUGFu Tiankang disposable vaginal filling suppository, Albothyl (Policresulen Solution) , and the gynecologic medical antimicrobial dressing gel (chitosan gel).
Sponsors
Jinan Military General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 78 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grading changes of nonneoplastic epithelial disorders from colposcopy and biopsy pathology | One month before treatment and 2,4,6 weeks and 2,6,12,24 monthes after treatment | 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. |
Countries
China
Contacts
Primary ContactGeping Yin, M.D.
Outcome results
None listed