Pelvic Organ ProlapseNCT04025047
A Multi-center Registry Study: The Follow-up the Complications for Trans-vaginal Mesh Surgery
An observational study of Pelvic Organ Prolapse, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a multi-center, prospective, observational, hospital-based registry of pelvic organ prolapse(POP) patients who having trans-vaginal mesh implantation with 12 month and 36 month follow-up.To investigate the incidence of postoperative complications according to the International Urogynecological… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- 4,147 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2019to Jun 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who prefer to undertake pelvic reconstruction surgery with trans-vaginal mesh for 1) a newly diagnosed severe POP: at least stage III (ICS-classification according to POP-Q system) in one or more compartments; 2) The failure or recurrence after pelvic floor reconstruction with native-tissue(symptomatic II and above).
Who may be able to join
- 1） Patients who undergo the pelvic reconstruction surgery with trans-vaginal mesh; 2) Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation; 3）Willing to participate in 36 months of longitudinal follow-up and able to provide written informed consent. Willing to provide an email address and complete questionnaires on we-chat, either in clinic or elsewhere when they have access to the internet.
Who cannot join
- 1) Currently pregnant at enrollment;
- 2) Physically or mentally unable to participate in up to 36 months of follow-up;
- 3) Desires other surgical management of POP other than trans-vaginal mesh.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Beijing, Beijing Municipality, 100730
Shuo Liang, MD, +86 13718879529, leahleung@foxmail.com
Lan Zhu, MD, +86 13911714696, zhu_julie@vip.sina.com
About this study
Official title: A Multi-center Registry Study: The Complications After Women Having Pelvic Reconstruction Surgery With Trans-vaginal Mesh
This is a multi-center, prospective, observational, hospital-based registry of pelvic organ prolapse(POP) patients who having trans-vaginal mesh implantation with 12 month and 36 month follow-up.To investigate the incidence of postoperative complications according to the International Urogynecological Association/International Continence Society (IUGA/ICS) complication classification system(the Category- Time-Site(CTS) coding).
Read the detailed description
Patients who undergo pelvic floor reconstructive surgery with trans-vaginal mesh for the cure of pelvic organ prolapse (POP) between June 2019 and December 2022 from 41 centers across the country are going to be prospectively collected. The study is designed to report the clinical data，outcomes and complications of transvaginal mesh surgery in China. The information gathered will identify the incidence rate of complications, especially mesh exposure/erosion, in Chinese women and whether published, professional guidelines on POP surgical treatment as well as mesh complications management are being applied appropriately. Findings from this registry may help in knowing the current status of transvaginal mesh use in China as well as identify issues that may affect the surgical outcome and complications occurrence. Based on the registry study, clinical practice on the management of transvaginal mesh implantation including selection patients, pre- and post-operative evaluation and complications surgical database will be established.
The follow-up process starts after patients have completed the operation; thus, our study does not affect patients' choice of surgical method.
- Conditions
- Pelvic Organ Prolapse
- Keywords
- trans-vaginal mesh, pelvic reconstruction surgery, complications, the CTS(category-time-site) coding system
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal mesh | Patients who undergo pelvic reconstruction surgery using trans-vaginal mesh (commercial mesh kits or self-cut synthesized mesh). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of complications
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).
Measured: 12 months postoperatively
The incidence rate of complications
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).
Measured: 36 months postoperatively
Secondary outcomes (6)
Anatomical cure rate in treated compartment of pelvic reconstructive surgery with trans-vaginal mesh
The percentage of patients who reach the anatomical success criteria at each time point（6 weeks, 3 months and each year, up to 3-year postoperatively）.The anatomical success is defined by a composite outcome that includes absence of vaginal bulge symptoms, absence of vaginal descent beyond the hymen and the absence of retreatment.
Measured: 6 weeks, 3 months and each year, up to 3-year postoperatively
Change from preoperative scores of POP-Q(Pelvic organ prolapse quantitation) at each follow-up
POP-Q is used for evaluation the severity(staging) of prolapse by pelvic examination preoperatively and postoperatively. The score is reported in cm. The changes from baseline scores at 6 weeks, 3 months, 1 year and up to 3 years postoperatively are respectively compared.
Measured: Preoperatively; At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively
Patient global impression of improvement (PGI-I)
The Chinese-version validated questionnaire PGI-I is used for assessing patients' subjective satisfaction to the pelvic floor reconstructions surgery.
The PGI-I score ranges from 0~7.
Measured: At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively
Changes in Pelvic Floor Distress Inventory-20 (PFDI-20) scores
The Chinese-version validated questionnaire Pelvic Floor Distress Inventory-short Form 20 scores [PFDI-20] is to evaluate the impact on pelvic floor function.
Measured: Preoperatively; At 1 year and 3 year postoperatively
Changes in Pelvic Floor Impact Questionnaire-7（PFIQ-7）scores
The Chinese-version validated questionnaire Pelvic Floor Impact Questionnaire-7 [PFIQ-7] is to evaluate the impact on quality of life.
Measured: Preoperatively; At 1 year and 3 year postoperatively
Changes in sexual function and measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire（PISQ-12）scores
The Chinese-version validated questionnaire Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire scores （PISQ-12） is to evaluate the impact on sexual function.
Measured: Preoperatively; At 1 year and 3 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start10 Apr 2019
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,147 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, The First Affiliated Hospital of Nanchang University, Jiangxi Maternal and Child Health Hospital, Fuzhou General Hospital, Obstetrics & Gynecology Hospital of Fudan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Affiliated Wuhu Clinical College of Nantong University, The Second Hospital of Anhui Medical University, Renmin Hospital of Wuhan University, Second Xiangya Hospital of Central South University, Changsha Hospital for Maternal and Child Health Care, The Third Xiangya Hospital of Central South University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shenzhen People's Hospital, Fourth Medical Center of PLA General Hospital, Beijing Chao Yang Hospital, The Second Affiliated Hospital of Harbin Medical University, Second Hospital of Jilin University, Shengjing Hospital, Yantai Yuhuangding Hospital, Shanxi Coal Center Hospital, Mianyang Central Hospital, West China Second University Hospital, Chongqing Medical Center for Women and Children, Southwest Hospital, China, Shaanxi Provincial People's Hospital, First Affiliated Hospital of Xinjiang Medical University, People's Hospital of Xinjiang Uygur Autonomous Region, Dalian Maternity and Child Care Hospital, Henan Provincial People's Hospital, Shanghai 10th People's Hospital, Shanghai First Maternity and Infant Hospital, Nanjing Maternity and Child Health Care Hospital, Affiliated Renhe Hospital of China Three Gorges University, China, Guizhou Provincial People's Hospital, The First Affiliated Hospital of Shihezi University, Yangpu District Central Hospital Affiliated to Tongji University, Wuhan Central Hospital
- Responsible party
- Principal investigator, zhulan, Peking Union Medical College Hospital
- Investigators
- Lan Zhu, MD, Principal investigator, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025047
- Sponsor's protocol ID
- JS-1979
- Status last verified
- Jul 2019
- First submitted
- 17 Jul 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Registry Study: The Complications After Women Having Pelvic Reconstruction Surgery With Trans-vaginal Mesh
- ClinicalTrials.gov ID
- NCT04025047
- Acronym / sponsor ID
- JS-1979
- Conditions
- Pelvic Organ Prolapse
- Keywords
- trans-vaginal mesh, pelvic reconstruction surgery, complications, the CTS(category-time-site) coding system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,147 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, The First Affiliated Hospital of Nanchang University, Jiangxi Maternal and Child Health Hospital, Fuzhou General Hospital, Obstetrics & Gynecology Hospital of Fudan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Affiliated Wuhu Clinical College of Nantong University, The Second Hospital of Anhui Medical University, Renmin Hospital of Wuhan University, Second Xiangya Hospital of Central South University, Changsha Hospital for Maternal and Child Health Care, The Third Xiangya Hospital of Central South University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shenzhen People's Hospital, Fourth Medical Center of PLA General Hospital, Beijing Chao Yang Hospital, The Second Affiliated Hospital of Harbin Medical University, Second Hospital of Jilin University, Shengjing Hospital, Yantai Yuhuangding Hospital, Shanxi Coal Center Hospital, Mianyang Central Hospital, West China Second University Hospital, Chongqing Medical Center for Women and Children, Southwest Hospital, China, Shaanxi Provincial People's Hospital, First Affiliated Hospital of Xinjiang Medical University, People's Hospital of Xinjiang Uygur Autonomous Region, Dalian Maternity and Child Care Hospital, Henan Provincial People's Hospital, Shanghai 10th People's Hospital, Shanghai First Maternity and Infant Hospital, Nanjing Maternity and Child Health Care Hospital, Affiliated Renhe Hospital of China Three Gorges University, China, Guizhou Provincial People's Hospital, The First Affiliated Hospital of Shihezi University, Yangpu District Central Hospital Affiliated to Tongji University, Wuhan Central Hospital
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 18 Jul 2019 (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.
This is a multi-center, prospective, observational, hospital-based registry of pelvic organ prolapse(POP) patients who having trans-vaginal mesh implantation with 12 month and 36 month follow-up.To investigate the incidence of postoperative complications according to the International Urogynecological Association/International Continence Society (IUGA/ICS) complication classification system(the Category- Time-Site(CTS) coding).
Detailed description
Patients who undergo pelvic floor reconstructive surgery with trans-vaginal mesh for the cure of pelvic organ prolapse (POP) between June 2019 and December 2022 from 41 centers across the country are going to be prospectively collected. The study is designed to report the clinical data，outcomes and complications of transvaginal mesh surgery in China. The information gathered will identify the incidence rate of complications, especially mesh exposure/erosion, in Chinese women and whether published, professional guidelines on POP surgical treatment as well as mesh complications management are being applied appropriately. Findings from this registry may help in knowing the current status of transvaginal mesh use in China as well as identify issues that may affect the surgical outcome and complications occurrence. Based on the registry study, clinical practice on the management of transvaginal mesh implantation including selection patients, pre- and post-operative evaluation and complications surgical database will be established.
The follow-up process starts after patients have completed the operation; thus, our study does not affect patients' choice of surgical method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transvaginal mesh | – | –Patients who undergo pelvic reconstruction surgery using trans-vaginal mesh (commercial mesh kits or self-cut synthesized mesh). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who prefer to undertake pelvic reconstruction surgery with trans-vaginal mesh for 1) a newly diagnosed severe POP: at least stage III (ICS-classification according to POP-Q system) in one or more compartments; 2) The failure or recurrence after pelvic floor reconstruction with native-tissue(symptomatic II and above).
Key inclusion criteria (1 listed)
- 1） Patients who undergo the pelvic reconstruction surgery with trans-vaginal mesh; 2) Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation; 3）Willing to participate in 36 months of longitudinal follow-up and able to provide written informed consent. Willing to provide an email address and complete questionnaires on we-chat, either in clinic or elsewhere when they have access to the internet.
Key exclusion criteria (3 listed)
- 1) Currently pregnant at enrollment;
- 2) Physically or mentally unable to participate in up to 36 months of follow-up;
- 3) Desires other surgical management of POP other than trans-vaginal mesh.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence rate of complications
Time frame: 12 months postoperatively
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).
The incidence rate of complications
Time frame: 36 months postoperatively
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).
6 secondary outcomes
Anatomical cure rate in treated compartment of pelvic reconstructive surgery with trans-vaginal mesh
Time frame: 6 weeks, 3 months and each year, up to 3-year postoperatively
Change from preoperative scores of POP-Q(Pelvic organ prolapse quantitation) at each follow-up
Time frame: Preoperatively; At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively
Patient global impression of improvement (PGI-I)
Time frame: At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively
Changes in Pelvic Floor Distress Inventory-20 (PFDI-20) scores
Time frame: Preoperatively; At 1 year and 3 year postoperatively
Changes in Pelvic Floor Impact Questionnaire-7（PFIQ-7）scores
Time frame: Preoperatively; At 1 year and 3 year postoperatively
Changes in sexual function and measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire（PISQ-12）scores
Time frame: Preoperatively; At 1 year and 3 year postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
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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, MD principal investigator
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Peking Union Medical College Hospital at 1 site 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 1 inclusion and 3 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 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Shuo Liang, MD (+8613718879529, leahleung@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of complications (time frame: 12 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2019.