Pelvic Organ ProlapseNCT05938881
Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study
An observational study of Pelvic Organ Prolapse, run by Peking Union Medical College Hospital at 11 sites in China.
Trial summary
The original RCT 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 at 1-year follow-up. Read more about this study
- Who is it for?
- Ages 53 to 75 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- self-cut mesh procedure and mesh-kit procedure
- Type of treatment
- Surgery or procedure
- How many people
- 336 participants
- Where
- 11 sitesChina
- Study dates
- 29 Jun 2023to 12 Mar 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 53 to 75 years
- Women only
- Adult, Older adult
Study population: All women enrolled in previous RCT study are invited to this extended study.
Who may be able to join
- Women enrolled in previous RCT study
Who cannot join
- Inability to provide informed consent. Informed consent will be obtained prior to each telephone interview and each in-person visit.
- Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Juan Chen
- Recruiting
Changsha Maternal and Child Health Care Hospital
Changsha, Hunan
Binan Wang
- Recruiting
The Secong Xiangya Hospital of Central South University
Changsha, Hunan
Guangshi Tao
- Recruiting
Sichuan University West China Second University Hospital
Chengdu, Sichuan
Ping Wang
- Recruiting
Foshan Maternal and Child Health Care Hospital
Foshan, Guangdong
Yuling Wang
- Recruiting
The First Affiliated Hospital of Guangdong Medical College
Guangzhou, Guangdong
Xiaowei Zhang
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Peishu Liu
- Recruiting
the First Affiliated Hosptial of Xinjiang Medical University
Ürümqi, Xiangjiang
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 Hosptial
Xi’an, Shanxi
Xiangyang Jiang
About this study
The original RCT 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 at 1-year follow-up. This study will follow women in the original RCT study for up to 10 years from the time of the surgery to compare success and complication rates in the two groups. Recruitment into this study is open only to women that already participated in previous RCT, no new treatment interventions will be given. Recruitment into the previous RCT is closed. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed.
Read the detailed description
The previous study is a randomized trial designed to compare the composite success rate between patients with self-cut mesh procedure and those with mesh-kit procedure. The original RCT study includes a 1-year follow up from the time of surgery, which is too short to evaluate the long-term sequelae of the surgical procedures. The goal of this long-term follow-up study is to extend the follow-up of women in the previous RCT study up to 10 years from the time of surgery and to compare the success and complication rates of the two surgical treatment groups over this extended time period.
The primary aim is to determine whether treatment success in women who undergo the above strategies differ at time points through 10 years. A supplemental study investigates the long-term success rate and complications of transvaginal mesh procedure in women in both of the study arms.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- self-cut mesh procedure, mesh-kit procedure
- Keywords
- pelvic organ prolapse, surgery plastic, pelvic floor, polypropylenes
- 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.
self-cut mesh procedureProcedure or surgery
transvaginal mesh procedure using self-cut mesh
mesh-kit procedureProcedure or surgery
transvaginal mesh procedure using mesh-kit
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: self-cut mesh procedure | |
| 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. Receives: Procedure: mesh-kit procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite success
To determine the long-term (up to 10 years) composite success rate of both procedure (defined as leading edge above the hymen (i.e Ba, C, Bp<0 cm) AND deny vaginal bulging symptoms 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? AND no re-operation or pessary treatment for POP), and whether composite success rate differs between women who had self-cut mesh procedure vs. those who had mesh-kit procedure; This outcome measure is cumulative across the original RCT trial and continued through the extended trial follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
Measured: up to 10 years after procedure
Secondary outcomes (6)
anatomic outcomes
Anatomic failure was defined as POPQ system leading edge at or beyond the hymen (i.e Ba, C, Bp≥0 cm). This outcome measure is cumulative across the original RCT trial and continued through the extended follow-up study with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
Measured: up to 10 years after operation
Change From Baseline PFIQ-7 Score
The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year [up to 10 years] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Measured: up to 10 years after operation
Change From Baseline PFDI-20 Score
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the CRADI is: 0-400 with 0 (least distress) to 400 (most distress). Change = (Year [up to 10 years] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Measured: up to 10 years after operation
Change From Baseline PISQ-12 Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, (PISQ-12) is a questionnaire measuring the impact of POP symptoms on sexual function and satisfaction. The PISQ-12 Score ranges from 0 to 48 with higher scores indicating better function/satisfaction. Change = (Year [up to 10 years] Score - Baseline Score). Higher scores indicate better function / fewer symptoms.
Measured: up to 10 years after operation
Symptomatic improvement using patient global impression of change (PGI-C)
The Patient Global Impression of Change (PGI-C) is a patient-reported measure of perceived change with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better).
Measured: up to 10 years after operation
Complications
Using IUGA/ICS Joint Terminology CTS coding system and Clavien-Dindo classification
Measured: up to 10 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start29 Jun 2023
- Primary completion12 Jan 2033 (estimated)
- Study completion12 Mar 2033 (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
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lan Zhu, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938881
- Sponsor's protocol ID
- extended TVM
- Status last verified
- Jul 2023
- First submitted
- 28 Jun 2023
- Last updated
- 11 Jul 2023
- 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 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study
- ClinicalTrials.gov ID
- NCT05938881
- Acronym / sponsor ID
- extended TVM
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse, surgery plastic, pelvic floor, polypropylenes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 12 Jan 2033 (estimated)
- Study completion
- 12 Mar 2033 (estimated)
- First posted
- 11 Jul 2023 (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.
The original RCT 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 at 1-year follow-up. This study will follow women in the original RCT study for up to 10 years from the time of the surgery to compare success and complication rates in the two groups. Recruitment into this study is open only to women that already participated in previous RCT, no new treatment interventions will be given. Recruitment into the previous RCT is closed. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed.
Detailed description
The previous study is a randomized trial designed to compare the composite success rate between patients with self-cut mesh procedure and those with mesh-kit procedure. The original RCT study includes a 1-year follow up from the time of surgery, which is too short to evaluate the long-term sequelae of the surgical procedures. The goal of this long-term follow-up study is to extend the follow-up of women in the previous RCT study up to 10 years from the time of surgery and to compare the success and complication rates of the two surgical treatment groups over this extended time period.
The primary aim is to determine whether treatment success in women who undergo the above strategies differ at time points through 10 years. A supplemental study investigates the long-term success rate and complications of transvaginal mesh procedure in women in both of the study arms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self-cut mesh procedure | – | Procedure: self-cut mesh procedureThis 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 | – | Procedure: mesh-kit procedureThis 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
- 53 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- All women enrolled in previous RCT study are invited to this extended study.
Key inclusion criteria (1 listed)
- Women enrolled in previous RCT study
Key exclusion criteria (2 listed)
- Inability to provide informed consent. Informed consent will be obtained prior to each telephone interview and each in-person visit.
- Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.
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 |
|---|---|---|
| self-cut mesh proceduretransvaginal mesh procedure using self-cut mesh | Procedure or surgery | self-cut mesh procedure |
| mesh-kit proceduretransvaginal mesh procedure using mesh-kit | Procedure or surgery | mesh-kit procedure |
Primary outcome
Composite success
Time frame: up to 10 years after procedure
To determine the long-term (up to 10 years) composite success rate of both procedure (defined as leading edge above the hymen (i.e Ba, C, Bp<0 cm) AND deny vaginal bulging symptoms 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? AND no re-operation or pessary treatment for POP), and whether composite success rate differs between women who had self-cut mesh procedure vs. those who had mesh-kit procedure; This outcome measure is cumulative across the original RCT trial and continued through the extended trial follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
6 secondary outcomes
anatomic outcomes
Time frame: up to 10 years after operation
Change From Baseline PFIQ-7 Score
Time frame: up to 10 years after operation
Change From Baseline PFDI-20 Score
Time frame: up to 10 years after operation
Change From Baseline PISQ-12 Score
Time frame: up to 10 years after operation
Symptomatic improvement using patient global impression of change (PGI-C)
Time frame: up to 10 years after operation
Complications
Time frame: up to 10 years after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
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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.
11 sites 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 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 11 Jul 2023. 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?
This study is still under way. Results are not available in the source record yet.
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?
Composite success (time frame: up to 10 years after procedure). 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 11 Jul 2023.