Pelvic Organ ProlapseNCT03283124
Comparing Transvaginal Self-tailored Titanium-coated Polypropylene Mesh Procedure With Mesh-kit Procedure.
A study testing pelvic floor reconstructive surgery in people with Pelvic Organ Prolapse, run by Peking Union Medical College Hospital at 11 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- pelvic floor reconstructive surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 11 sitesChina
- Study dates
- 12 Jan 2018to 12 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Juan Chen
- Recruiting
Changsha Maternal and Child Health Care Hospital
Changsha, Hunan
Binan Wang
- Recruiting
The second Xiangya Hospital of Central South University
Changsha, Hunan
guangshi Tao
- Recruiting
Sichuan University West China Second University Hospital
Chengdu, Sichuan
Ping Wang
- Recruiting
Fosha Maternal and Child Health Care Hospital
Foshan, Guangdong
Yuling Wang
- Recruiting
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong
xiaowei zhang
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Peishu Liu
- Recruiting
the First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Gulina Ababaikeli
- Recruiting
the People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang
Hatiguli Nisier
- Recruiting
Wuxi Maternal and Child Health Care Hospital
Wuxi, Jiangsu
Jian Gong
- Recruiting
Shanxi Provincial People's Hospital
Xi’an, Shanxi
Xiangyang Jiang
About this study
Official title: A Multicenter Randomized Controlled Non-inferiority Trial Comparing Transvaginal Self-tailored Titanium-coated Polypropylene Mesh Procedure With Mesh-kit Procedure.
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 .
Read the 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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- pelvic floor reconstructive surgery
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic floor reconstructive surgeryProcedure or surgery
transvaginal mesh implantation for pelvic organ prolapse
| Study group | Role | What they receive |
|---|---|---|
| self-cut mesh procedure | Active comparator | 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. Receives: Procedure: pelvic floor reconstructive surgery |
| mesh-kit procedure | Active comparator | 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. Receives: Procedure: pelvic floor reconstructive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: up to 36 months after operation
Secondary outcomes (8)
anatomic outcomes
anatomic outcome of each vaginal segment( anterior, posterior and apical) using POP-Q score.
Measured: up to 36 months after operation
symptomatic improvement using validated instruments(PFIQ-7)
Relief of symptoms using validated instruments(PFIQ-7) .
Measured: up to 36 months after operation
symptomatic improvement using validated instruments(PFDI-20)
Relief of symptoms using validated instruments(PFDI-20) .
Measured: up to 36 months after operation
symptomatic improvement using validated instruments(PISQ-12)
Relief of symptoms using validated instruments(PISQ-12)
Measured: up to 36 months after operation
symptomatic improvement using patient global impression of change (PGI-C)
Relief of symptoms using patient global impression of change (PGI-C)
Measured: up to 36 months after operation
intraoperative and post operative complications
using IUGA/ICS joint terminology CTS coding system and dingo system
Measured: up to 36 months after operation
post operative pain
visual analogue scales (VAS) were used to evaluate the degree of pain.
Measured: within 3 days after operation
Hospital costs
hospitlization expenses
Measured: up to 4 weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start12 Jan 2018
- Primary completion12 Jan 2020 (estimated)
- Study completion12 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Medstron Medical Co.Ltd, LinkDoc Technology (Beijing) Co. Ltd., Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Lan Zhu, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283124
- Sponsor's protocol ID
- self-cut mesh vs mesh-kit
- Status last verified
- Feb 2019
- First submitted
- 7 May 2017
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36112377Chen 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.
PubMed 32102687
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Non-inferiority Trial Comparing Transvaginal Self-tailored Titanium-coated Polypropylene Mesh Procedure With Mesh-kit Procedure.
- ClinicalTrials.gov ID
- NCT03283124
- Acronym / sponsor ID
- self-cut mesh vs mesh-kit
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Shanghai Medstron Medical Co.Ltd, LinkDoc Technology (Beijing) Co. Ltd., Chinese Academy of Medical Sciences
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 12 Jan 2020 (estimated)
- Study completion
- 12 Jan 2022 (estimated)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self-cut mesh procedure | Active comparator | Procedure: pelvic floor reconstructive surgeryThis 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. |
| mesh-kit procedure | Active comparator | Procedure: pelvic floor reconstructive surgeryThis 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pelvic floor reconstructive surgerytransvaginal mesh implantation for pelvic organ prolapse | Procedure or surgery | mesh-kit procedure, self-cut mesh procedure |
Primary outcome
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?
8 secondary outcomes
anatomic outcomes
Time frame: up to 36 months after operation
symptomatic improvement using validated instruments(PFIQ-7)
Time frame: up to 36 months after operation
symptomatic improvement using validated instruments(PFDI-20)
Time frame: up to 36 months after operation
symptomatic improvement using validated instruments(PISQ-12)
Time frame: up to 36 months after operation
symptomatic improvement using patient global impression of change (PGI-C)
Time frame: up to 36 months after operation
intraoperative and post operative complications
Time frame: up to 36 months after operation
post operative pain
Time frame: within 3 days after operation
Hospital costs
Time frame: up to 4 weeks after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Derived from this study: PubMed 36112377Chen 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.
- Derived from this study: PubMed 32102687Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lan Zhu principal investigator
Peking Union Medical College Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pelvic floor reconstructive surgery in people with Pelvic Organ Prolapse, run by Peking Union Medical College Hospital at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lan Zhu (86-10-69155749, zhu_julie@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical "success" (time frame: up to 36 months after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03283124, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.