Back to resultsRCT for Transvaginal Self-cut Mesh vs Mesh-kit for Severe POP
Primary Purpose
Pelvic Organ Prolapse
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pelvic floor reconstructive surgery
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse
Eligibility Criteria
Inclusion Criteria:
- Age:More than 50 year with more than 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
Sites / Locations
- Peking Union Medical College HospitalRecruiting
- Fosha Maternal and Child Health Care HospitalRecruiting
- The First Affiliated Hospital of Guangzhou Medical CollegeRecruiting
- Changsha Maternal and Child Health Care HospitalRecruiting
- The second Xiangya Hospital of Central South UniversityRecruiting
- Wuxi Maternal and Child Health Care HospitalRecruiting
- Qilu Hospital of Shandong UniversityRecruiting
- Shanxi Provincial People's HospitalRecruiting
- Sichuan University West China Second University HospitalRecruiting
- the First Affiliated Hospital of Xinjiang Medical UniversityRecruiting
- the People's Hospital of Xinjiang Uygur Autonomous RegionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
self-cut mesh procedure
mesh-kit procedure
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
surgical "success"
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?
Secondary Outcome Measures
anatomic outcomes
anatomic outcome of each vaginal segment( anterior, posterior and apical) using POP-Q score.
symptomatic improvement using validated instruments(PFIQ-7)
Relief of symptoms using validated instruments(PFIQ-7) .
symptomatic improvement using validated instruments(PFDI-20)
Relief of symptoms using validated instruments(PFDI-20) .
symptomatic improvement using validated instruments(PISQ-12)
Relief of symptoms using validated instruments(PISQ-12)
symptomatic improvement using patient global impression of change (PGI-C)
Relief of symptoms using patient global impression of change (PGI-C)
intraoperative and post operative complications
using IUGA/ICS joint terminology CTS coding system and dingo system
post operative pain
visual analogue scales (VAS) were used to evaluate the degree of pain.
Full Information
NCT ID
NCT03849157
First Posted
February 19, 2019
Last Updated
February 19, 2019
Sponsor
Peking Union Medical College Hospital
Collaborators
Shanghai Medstron Medical Co.Ltd, Chinese Academy of Medical Sciences, LinkDoc Technology (Beijing) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03849157
Brief Title
RCT for Transvaginal Self-cut Mesh vs Mesh-kit for Severe POP
Official Title
A Multicenter Randomized Controlled Non-inferiority Trial Comparing Transvaginal Self-tailored Titanium-coated Polypropylene Mesh Procedure With Mesh-kit Procedure.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 12, 2018 (Actual)
Primary Completion Date
January 12, 2020 (Anticipated)
Study Completion Date
January 12, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Shanghai Medstron Medical Co.Ltd, Chinese Academy of Medical Sciences, LinkDoc Technology (Beijing) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pelvic organ prolapse(POP) is a common health problem and has significant negative effects on woman's quality of life. Transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kits are expensive for underdeveloped countries. Our preliminary trial showed that the use of self-tailored mesh had good success rate (91.8% at 1-year follow-up) and low complication rate. The trial is designed to compare self-tailored titanium-coated polypropylene mesh procedure with mesh-kit in the treatment of POP stage III-IV in terms of efficacy, safety and cost-effective .
Detailed Description
The trial is a randomized controlled multi-center non-inferiority trial. The primary outcome measure is success rate at 1-year follow-up. The second outcomes are subjective improvement of quality of life, complications and costs. Analysis will be performed according to the intention to treat principle. Based on comparable success rate of 90% and 10% as the margin(beta 0.2 and one sided alpha 0.025), about 312 patients in total from 11 centers will be recruited per group including 10% drop-out. The aims of the research are to demonstrate whether self-tailored mesh is non-inferior to the mesh-kit. The finding of this research might influence the treatment selection for POP in China.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
participant and investigator are not blinded. outcome assessor who are in charge of follow-up assement is masked.
Allocation
Randomized
Enrollment
312 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
self-cut mesh procedure
Arm Type
Active Comparator
Arm Description
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.
Arm Title
mesh-kit procedure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
pelvic floor reconstructive surgery
Intervention Description
transvaginal mesh implantation for pelvic organ prolapse
Primary Outcome Measure Information:
Title
surgical "success"
Description
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?
Time Frame
up to 36 months after operation
Secondary Outcome Measure Information:
Title
anatomic outcomes
Description
anatomic outcome of each vaginal segment( anterior, posterior and apical) using POP-Q score.
Time Frame
up to 36 months after operation
Title
symptomatic improvement using validated instruments(PFIQ-7)
Description
Relief of symptoms using validated instruments(PFIQ-7) .
Time Frame
up to 36 months after operation
Title
symptomatic improvement using validated instruments(PFDI-20)
Description
Relief of symptoms using validated instruments(PFDI-20) .
Time Frame
up to 36 months after operation
Title
symptomatic improvement using validated instruments(PISQ-12)
Description
Relief of symptoms using validated instruments(PISQ-12)
Time Frame
up to 36 months after operation
Title
symptomatic improvement using patient global impression of change (PGI-C)
Description
Relief of symptoms using patient global impression of change (PGI-C)
Time Frame
up to 36 months after operation
Title
intraoperative and post operative complications
Description
using IUGA/ICS joint terminology CTS coding system and dingo system
Time Frame
up to 36 months after operation
Title
post operative pain
Description
visual analogue scales (VAS) were used to evaluate the degree of pain.
Time Frame
within 3 days after operation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
53 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age:More than 50 year with more than 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lan Zhu
Phone
86-10-69155749
Email
zhu_julie@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Chen
Phone
86-10-69155749
Email
pumchcj@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lan Zhu
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Chen
Facility Name
Fosha Maternal and Child Health Care Hospital
City
Foshan
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuling Wang
Facility Name
The First Affiliated Hospital of Guangzhou Medical College
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaowei zhang
Facility Name
Changsha Maternal and Child Health Care Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binan Wang
Facility Name
The second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
guangshi Tao
Facility Name
Wuxi Maternal and Child Health Care Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Gong
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peishu Liu
Facility Name
Shanxi Provincial People's Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangyang Jiang
Facility Name
Sichuan University West China Second University Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Wang
Facility Name
the First Affiliated Hospital of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gulina Ababaikeli
Facility Name
the People's Hospital of Xinjiang Uygur Autonomous Region
City
Ürümqi
State/Province
Xinjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hatiguli Nisier
12. IPD Sharing Statement
Plan to Share IPD
No
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RCT for Transvaginal Self-cut Mesh vs Mesh-kit for Severe POP
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