- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03283124
Comparing Transvaginal Self-tailored Titanium-coated Polypropylene Mesh Procedure With Mesh-kit Procedure.
A Multicenter Randomized Controlled Non-inferiority Trial Comparing Transvaginal Self-tailored Titanium-coated Polypropylene Mesh Procedure With Mesh-kit Procedure.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China
- Recruiting
- Peking Union Medical College Hospital
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Guangdong
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Foshan, Guangdong, China
- Recruiting
- Fosha Maternal and Child Health Care Hospital
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Guangzhou, Guangdong, China
- Recruiting
- The First Affiliated Hospital of Guangzhou Medical College
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Hunan
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Changsha, Hunan, China
- Recruiting
- The Second Xiangya Hospital of Central South University
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Changsha, Hunan, China
- Recruiting
- Changsha Maternal and Child Health Care Hospital
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Jiangsu
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Wuxi, Jiangsu, China
- Recruiting
- Wuxi Maternal and Child Health Care Hospital
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Shandong
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Jinan, Shandong, China
- Recruiting
- Qilu Hospital of Shandong University
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Shanxi
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Xi'an, Shanxi, China
- Recruiting
- Shanxi Provincial People's Hospital
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Sichuan
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Chengdu, Sichuan, China
- Recruiting
- Sichuan University West China Second University Hospital
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Xinjiang
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Ürümqi, Xinjiang, China
- Recruiting
- The First Affiliated Hospital of Xinjiang Medical University
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Ürümqi, Xinjiang, China
- Recruiting
- The People's hospital of Xinjiang Uygur Autonomous Region
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age:More than 50 years old with 3 years after menopause or more than 55 years old, but less than 75 years old.
- Subject must have severe apical or anterior vaginal prolapse (stage III-IV), with moderate posterior vaginal prolapse(stage I-II). This is defined as ( C > +1cm OR Ba > +1cm, with Bp ≤+1cm by the POP-Q). This is the most common modality of multiple compartment POP in clinic.
- Subject reports a bothersome bulge they can see or feel per PFDI-20, question 3, response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit").
- Desires transvaginal mesh treatment for primary or recurrent, symptomatic uterovaginal prolapse.
- Concomitant hysterectomy when indicated. But concomitant anti-incontinence surgeries will not be enrolled.
- Subject is willing and able to comply with the follow-up regimen.
Exclusion Criteria:
- Subject is pregnant or intends to become pregnant in the future
- Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
- Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, colo-rectal or cervical)
- Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
- Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
- Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis, polymyalgia rheumatica)
- Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
- Subject has uncontrolled diabetes mellitus (DM)
- Subject has a known neurologic or medical condition affecting bladder function (e.g., multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit)
- Subject has had previous prolapse repair with mesh in the target compartment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: self-cut mesh procedure
This procedure is transvaginal mesh implantation surgery for POP patients.
Self-cut mesh procedure is an economic pelvic reconstructive surgical operation with use of specially designed puncture needles and self-cut mesh, which mainly provide anterior and apical compartments support, with posterior compartment reinforced by bridge technique repair.
The mesh pieces used in this surgery was cut from a single piece of mesh material(TiLOOP 10*15cm) which is much cheaper and readily available.
Patients could have transvaginal hysterectomy concomitantly.
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transvaginal mesh implantation for pelvic organ prolapse
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Active Comparator: mesh-kit procedure
This procedure is transvaginal mesh implantation surgery for POP patients.Mesh-kit procedure is refered to pelvic floor reconstructive surgery with titanium-coated meshes kit(TiLOOP TOTAL6).Patients could have transvaginal hysterectomy concomitantly.
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transvaginal mesh implantation for pelvic organ prolapse
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
surgical "success"
Time Frame: up to 36 months after operation
|
Subjects will be considered a success if they meet the definitions of anatomic cure and deny vaginal bulging symptoms, and no additional treatment for prolapse(surgical or pessary use). Anatomic cure is defined as leading edge above the hymen (i.e Ba, C, Bp<0 cm) Symptomatic cure is defined as the absence of vaginal bulge symptoms as indicated by a negative response question 3 of the pelvic floor distress inventory- 20 (PFDI-20): "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area? |
up to 36 months after operation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intraoperative and post operative complications
Time Frame: up to 36 months after operation
|
using IUGA/ICS joint terminology CTS coding system and dingo system
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up to 36 months after operation
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anatomic outcomes
Time Frame: up to 36 months after operation
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anatomic outcome of each vaginal segment( anterior, posterior and apical) using POP-Q score.
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up to 36 months after operation
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symptomatic improvement using validated instruments(PFIQ-7)
Time Frame: up to 36 months after operation
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Relief of symptoms using validated instruments(PFIQ-7) .
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up to 36 months after operation
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symptomatic improvement using validated instruments(PFDI-20)
Time Frame: up to 36 months after operation
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Relief of symptoms using validated instruments(PFDI-20) .
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up to 36 months after operation
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symptomatic improvement using validated instruments(PISQ-12)
Time Frame: up to 36 months after operation
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Relief of symptoms using validated instruments(PISQ-12)
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up to 36 months after operation
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symptomatic improvement using patient global impression of change (PGI-C)
Time Frame: up to 36 months after operation
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Relief of symptoms using patient global impression of change (PGI-C)
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up to 36 months after operation
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post operative pain
Time Frame: within 3 days after operation
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visual analogue scales (VAS) were used to evaluate the degree of pain.
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within 3 days after operation
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Hospital costs
Time Frame: up to 4 weeks after operation
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hospitlization expenses
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up to 4 weeks after operation
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Collaborators and Investigators
Publications and helpful links
General Publications
- Chen J, Yu J, Morse A, Tao G, Gong J, Wang B, Wang Y, Ababaikeli G, Jiang X, Liu P, Zhang X, Nisier H, Wang P, Funfgeld C, Huang K, Zhang H, Sun X, Zhu L. Effectiveness of Self-cut vs Mesh-Kit Titanium-Coated Polypropylene Mesh for Transvaginal Treatment of Severe Pelvic Organ Prolapse: A Multicenter Randomized Noninferiority Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2231869. doi: 10.1001/jamanetworkopen.2022.31869.
- Chen J, Yu J, Morse A, Funfgeld C, Huang K, Gong J, Tao G, Wang B, Wang Y, Jiang X, Ababaikeli G, Liu P, Nisier H, Zhang X, Wang P, Sun X, Zhu L. Self-cut titanium-coated polypropylene mesh versus pre-cut mesh-kit for transvaginal treatment of severe pelvic organ prolapse: study protocol for a multicenter non-inferiority trial. Trials. 2020 Feb 26;21(1):226. doi: 10.1186/s13063-019-3966-3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- self-cut mesh vs mesh-kit
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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