The Effect of New-style Vaginal Repair Mesh in the Treatment of Female Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02934490
• Other study ID #: 2013ZX05
• Status: Recruiting
• Phase: N/A
• First received: September 23, 2016
• Last updated: January 11, 2017
• Start date: January 2009
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Jinan Military General Hospital
• Contact: Geping Yin, M.D.
• Phone: 86-0531-51666230
• Email: ygpwylll[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Jinan Municipality
• Study type: Interventional

Clinical Trial Summary

The study is to explore the effectiveness of a new-style anterior vaginal wall mesh in the treatment of female stress urinary incontinence(SUI). Meshes were made by Gynemech TM PS, (Johnson & Johnson Shanghai Medical Equipment Co. China Food and Drug Administration (CFDA) registration No. 3460365, size 10 × 15cm). Meshes were cut to appropriate size. The incontinence questionnaire summary table (ICIQ-SF), pad test, urodynamic and other diagnostic tests were used for preoperative assessment and the evaluation of postoperative surgical outcome and complication. The results were compared with the one-year cure rates of Burch and trans vaginal taping (TVT) surgeries. The analysis indicated that the surgery using the new-style anterior vaginal mesh, as a minimally invasive procedure, not only achieved its expectation with similar cure rate to Burch, TVT/ trans vaginal taping obturator (TVT-O) surgeries, but also has lower economic cost and complication rate than the TVT /TVT-O approach. The evaluation of long-term treatment effect needs further follow-up of the patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 316
• Est. completion date: December 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 27 Years to 82 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Mesh
Meshes were made by Gynemech TM PS, (Johnson & Johnson Shanghai Medical Equipment Co. SFDA registration No. 3460365, size 10 × 15cm)

Locations

Country	Name	City	State
China	Jinan Military General Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Jinan Military General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomy of female perineal bilateral pubic bones	Anatomy of the main parameters of bilateral gap: female perineum pubis bilateral acupoint location, angle, length and width of the acupuncture points.	Two months before treatment	No
Primary	Anatomy of female perineal bilateral pubic bones	Anatomy of the main parameters of bilateral gap: female perineum pubis bilateral acupoint location, angle, length and width of the acupuncture points.	One month after treatment	No
Primary	Incontinence questionnaire summary table observation	Incontinence questionnaire summary observation to evaluate the therapeutic effect of the study on the implantation of mesh in female stress urinary incontinence. If there are complications, including the cough so, sneezing or laughing, and lifting whether there is leakage of urine and preoperative contrast, whether the situation is better; whether the quality of life. The increase; whether the foreign body discomfort; and other discomfort.	Three months before treatment	No
Primary	Incontinence questionnaire summary table observation	Incontinence questionnaire summary observation to evaluate the therapeutic effect of the study on the implantation of mesh in female stress urinary incontinence. If there are complications, including the cough so, sneezing or laughing, and lifting whether there is leakage of urine and preoperative contrast, whether the situation is better; whether the quality of life. The increase; whether the foreign body discomfort; and other discomfort.	Six months after treatment	No
Primary	Incontinence pad weight test		Three months before treatment	No
Primary	Incontinence pad weight test		Six months after treatment	No