The Effect of New-style Vaginal Repair Mesh in the Treatment of Female Stress Urinary Incontinence
1 other identifier
interventional
316
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 23, 2016
CompletedFirst Posted
Study publicly available on registry
October 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJanuary 13, 2017
January 1, 2017
8.1 years
September 23, 2016
January 11, 2017
Conditions
Outcome Measures
Primary Outcomes (6)
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
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
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
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
Incontinence pad weight test
Three months before treatment
Incontinence pad weight test
Six months after treatment
Study Arms (1)
Treatment group
EXPERIMENTALInterventions
Meshes were made by Gynemech TM PS, (Johnson \& Johnson Shanghai Medical Equipment Co. SFDA registration No. 3460365, size 10 × 15cm)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jinan Military General Hospital
Jinan, Shandong, 250031, China
Related Publications (1)
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.
PMID: 29478148DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
September 23, 2016
First Posted
October 17, 2016
Study Start
January 1, 2009
Primary Completion
February 1, 2017
Study Completion
December 1, 2017
Last Updated
January 13, 2017
Record last verified: 2017-01