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

January 11, 2017 updated by: Geping Yin, Jinan Military General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

316

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250031
        • Recruiting
        • Jinan Military General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

27 years to 82 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment group
Device: Mesh
Meshes were made by Gynemech TM PS, (Johnson & Johnson Shanghai Medical Equipment Co. SFDA registration No. 3460365, size 10 × 15cm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anatomy of female perineal bilateral pubic bones
Time Frame: Two months before treatment
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
Anatomy of female perineal bilateral pubic bones
Time Frame: One month after treatment
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
Incontinence questionnaire summary table observation
Time Frame: Three months before treatment
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
Incontinence questionnaire summary table observation
Time Frame: Six months after treatment
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
Incontinence pad weight test
Time Frame: Three months before treatment
Three months before treatment
Incontinence pad weight test
Time Frame: Six months after treatment
Six months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinan Military General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ANTICIPATED)

February 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

October 13, 2016

First Posted (ESTIMATE)

October 17, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013ZX05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress Urinary Incontinence

Clinical Trials on Mesh

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe