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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stress Urinary Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

Group Type EXPERIMENTAL

Mesh

Intervention Type DEVICE

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

Interventions

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Mesh

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

Intervention Type DEVICE

Eligibility Criteria

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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

27 Years

Maximum Eligible Age

82 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No