Nonneoplastic Epithelial Disorders of Vulva and High Intensity Focused Ultrasound

Not Applicable

• Conditions: Vulva Intraepithelial Nonneoplastic
• Interventions: Device: the high intensity focused ultrasound (Mianyang Sonic electronic LLC); Drug: Fu Tiankang disposable vaginal filling suppository, Albothyl (Policresulen Solution) , and the gynecologic medical antimicrobial dressing gel (chitosan gel).

• Registration Number: NCT02890277
• Lead Sponsor: Jinan Military General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-14
• Study Start: 2016-01
• Study First Submitted QC: 2016-08-31
• Study First Posted: 2016-09-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-13
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	the high intensity focused ultrasound (Mianyang Sonic electronic LLC)	-
Treatment group	Fu Tiankang disposable vaginal filling suppository, Albothyl (Policresulen Solution) , and the gynecologic medical antimicrobial dressing gel (chitosan gel).	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Jinan Military General Hospital; 🇨🇳 Jinan, Shandong, China