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

Primary Purpose

Stress Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mesh
Sponsored by
Jinan Military General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

27 Years - 82 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Jinan Military General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Incontinence pad weight test
Incontinence pad weight test

Secondary Outcome Measures

Full Information

First Posted
September 23, 2016
Last Updated
January 11, 2017
Sponsor
Jinan Military General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02934490
Brief Title
The Effect of New-style Vaginal Repair Mesh in the Treatment of Female Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinan Military General Hospital

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
316 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Mesh
Intervention Description
Meshes were made by Gynemech TM PS, (Johnson & Johnson Shanghai Medical Equipment Co. SFDA registration No. 3460365, size 10 × 15cm)
Primary Outcome Measure Information:
Title
Anatomy of female perineal bilateral pubic bones
Description
Anatomy of the main parameters of bilateral gap: female perineum pubis bilateral acupoint location, angle, length and width of the acupuncture points.
Time Frame
Two months before treatment
Title
Anatomy of female perineal bilateral pubic bones
Description
Anatomy of the main parameters of bilateral gap: female perineum pubis bilateral acupoint location, angle, length and width of the acupuncture points.
Time Frame
One month after treatment
Title
Incontinence questionnaire summary table observation
Description
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.
Time Frame
Three months before treatment
Title
Incontinence questionnaire summary table observation
Description
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.
Time Frame
Six months after treatment
Title
Incontinence pad weight test
Time Frame
Three months before treatment
Title
Incontinence pad weight test
Time Frame
Six months after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
27 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geping Yin, M.D.
Phone
86-0531-51666230
Email
ygpwylll@hotmail.com
Facility Information:
Facility Name
Jinan Military General Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geping Yin, M.D.
Phone
86-0531-51666230
Email
ygpwylll@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
29478148
Citation
Yin G, Yuan Z, Li J, Liang J, Wu A, Liu N. A new treatment of female stress urinary incontinence with vaginal antetheca-retropubic space mesh repair surgery: a clinical trial. World J Urol. 2018 Jul;36(7):1103-1109. doi: 10.1007/s00345-018-2234-6. Epub 2018 Feb 24.
Results Reference
derived

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

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