Clinical trial NCT02934490: The Effect of New-style Vaginal Repair Mesh in the Treatment of Female Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Jinan Military General Hospital
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 316
Sex: FEMALE
Minimum age (years): 27
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Anatomy of female perineal bilateral pubic bones
timeFrame: Two months before treatment
measure: Anatomy of female perineal bilateral pubic bones
timeFrame: One month after treatment
measure: Incontinence questionnaire summary table observation
timeFrame: Three months before treatment
measure: Incontinence questionnaire summary table observation
timeFrame: Six months after treatment
measure: Incontinence pad weight test
timeFrame: Three months before treatment
measure: Incontinence pad weight test
timeFrame: Six months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Jinan Military General Hospital
state: Shandong
Study officials:
References:
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.