RCT for Transvaginal Self-cut Mesh vs Mesh-kit for Severe POP
NCT ID: NCT03849157
Last Updated: 2019-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
312 participants
INTERVENTIONAL
2018-01-12
2022-01-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
pelvic floor reconstructive surgery
transvaginal mesh implantation for pelvic organ prolapse
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.
pelvic floor reconstructive surgery
transvaginal mesh implantation for pelvic organ prolapse
Interventions
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pelvic floor reconstructive surgery
transvaginal mesh implantation for pelvic organ prolapse
Eligibility Criteria
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Inclusion Criteria
* 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 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
53 Years
75 Years
FEMALE
No
Sponsors
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Shanghai Medstron Medical Co.Ltd
UNKNOWN
Chinese Academy of Medical Sciences
OTHER
LinkDoc Technology (Beijing) Co. Ltd.
INDUSTRY
Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Lan Zhu
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fosha Maternal and Child Health Care Hospital
Foshan, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
Changsha Maternal and Child Health Care Hospital
Changsha, Hunan, China
The second Xiangya Hospital of Central South University
Changsha, Hunan, China
Wuxi Maternal and Child Health Care Hospital
Wuxi, Jiangsu, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shanxi Provincial People's Hospital
Xi’an, Shanxi, China
Sichuan University West China Second University Hospital
Chengdu, Sichuan, China
the First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
the People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
Countries
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Central Contacts
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Facility Contacts
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Juan Chen
Role: primary
Yuling Wang
Role: primary
xiaowei zhang
Role: primary
Binan Wang
Role: primary
guangshi Tao
Role: primary
Jian Gong
Role: primary
Peishu Liu
Role: primary
Xiangyang Jiang
Role: primary
Ping Wang
Role: primary
Gulina Ababaikeli
Role: primary
Hatiguli Nisier
Role: primary
Other Identifiers
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protocol for TVM
Identifier Type: -
Identifier Source: org_study_id
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