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

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ClinicalTrials.gov Identifier: NCT02934490
Recruitment Status : Unknown
Verified January 2017 by Geping Yin, Jinan Military General Hospital.
Recruitment status was:  Recruiting
First Posted : October 17, 2016
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Geping Yin, Jinan Military General Hospital

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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Device: Mesh Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 316 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2009
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Incontinence pad weight test [ Time Frame: Three months before treatment ]
  6. Incontinence pad weight test [ Time Frame: Six months after treatment ]


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Ages Eligible for Study:   27 Years to 82 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934490


Contacts
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Contact: Geping Yin, M.D. 86-0531-51666230 ygpwylll@hotmail.com

Locations
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China, Shandong
Jinan Military General Hospital Recruiting
Jinan, Shandong, China, 250031
Contact: Geping Yin, M.D.    86-0531-51666230    ygpwylll@hotmail.com   
Sponsors and Collaborators
Jinan Military General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Geping Yin, Director, Jinan Military General Hospital
ClinicalTrials.gov Identifier: NCT02934490     History of Changes
Other Study ID Numbers: 2013ZX05
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders