Uterine ProlapseNCT01762384
Laparoscopic Sacral Colpopexy Versus Modified Total Pelvic Floor Reconstructive Surgery for Apical Prolapse Stage III-IV
A study testing LSC, modified PFRS and "Gynemesh" in people with Uterine Prolapse and Vault Prolapse, run by Peking Union Medical College Hospital at 4 sites in China.
Trial summary
Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with patient's sex life. The primary treatment is surgery. Sacral Colpopexy is the gold standard procedure. Now it could be done laparoscopically. Read more about this study
- Who is it for?
- Ages 55 to 65 years, women only
- Conditions the study is for
- Uterine Prolapse, Vault Prolapse
- What is being tested?
- LSC, modified PFRS and "Gynemesh"
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesChina
- Study dates
- Dec 2012to Dec 2017
- 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 55 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates with symptomatic uterine or vault prolapse of Stage III-IV, suitable for surgical repair.
- Age from 55-65 years old.
- Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires.
Who cannot join
- Patients who could not tolerate laparoscopic surgery.
- Previous repair of pelvic organ prolapse involving insertion of mesh.
- Experimental drug or experimental medical device within 3 months prior to the planned procedure.
- Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
- Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
- History of chemotherapy or pelvic radiation therapy. Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spinal cord injury or trauma).
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- Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
- Nursing or pregnant or intends future pregnancy.
- Chronic cough not well-controlled.
- BMI ≥ 30.
- In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Lan Zhu, 86-13911714696
- Recruiting
The First Affiliated Hospital of Guangzhou Medical College
Ghuangzhou, Guangdong, 510120
Xiaowei Zhang, 86-13609086710, xwzhang81341235@163.com
- Recruiting
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006
Hangmei Jin, jinhm@zju.edu.cn
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Mei Ji, jimei0821@yahoo.com.cn
About this study
Official title: Nationwide Multicenter Randomized Prospective Study to Compare Laparoscopic Sacral Colpopexy and Modified Total Pelvic Floor Reconstructive Surgery With Mesh for Apical Prolapse Stage III-IV
Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with patient's sex life. The primary treatment is surgery. Sacral Colpopexy is the gold standard procedure. Now it could be done laparoscopically. Modified total pelvic floor reconstructive surgery with mesh is developed in China for Asian Women.
This study is designed to determine the effectiveness and safety of Modified total pelvic floor reconstructive surgery with mesh compared with laparoscopic Sacral Colpopexy for the treatment of uterine or vault prolapse Stage III-IV.
Patients enrolled into the study will be followed up for up to 3 years after surgery. Evaluation will take place during surgery and postoperative visit. Stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates will be evaluated.
Read the detailed description
Pelvic organ prolapse is a common problem. The high rate of failure has led to an increasing use of synthetic grafts to augment vaginal repair procedures to obtain more durable results. In 2005, the investigators began to perform modified pelvic floor reconstruction surgery with mesh. The nation-wide multicenter prospective clinical trial data showed that it was safe, efficient and cost-effective. No severe intraoperative complications were recorded and the recurrence rate after 1 year follow-up was 8.1%. Quality of life improved significantly from the baseline, while the sexual function did not change.
Sacral colpopexy has long been regarded as the gold standard. Laparoscopic sacral colpopexy could offer durable result and low morbidity compared with open procedure.
In clinical practice, many women have symptomatic POP-Q Stage III-IV uterine or vault prolapse, which requires surgical correction. The aim of this multicenter, prospective and randomized study is to evaluate the effectiveness and safety of these two procedures in the treatment of symptomatic apical prolapse Stage III-IV in China.
- Conditions
- Uterine Prolapse, Vault Prolapse
- Being tested
- LSC, modified PFRS, "Gynemesh"
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSCProcedure or surgery
subjects of this group are submitted to surgical treatment of laparoscopic sacral colpopexy.
modified PFRSProcedure or surgery
subjects of this group are submitted to modified pelvic floor reconstructive surgery with mesh.
"Gynemesh"Device
Both surgeries will be conducted using mesh constructed from polypropylene mesh.
| Study group | Role | What they receive |
|---|---|---|
| LSC | Active comparator | procedure: laparoscopic sacral colpopexy. Receives: Procedure: LSC; Device: "Gynemesh" |
| Modified PFRS | Active comparator | procedure: modified pelvic floor reconstructive surgery with mesh. Receives: Procedure: modified PFRS; Device: "Gynemesh" |
What is being measured
The primary outcome is the main question the study is designed to answer.
anatomical improvement according to POP-Q score
Measured: 6 months
Anatomical improvement according to POP-Q Score
Measured: 1 year
Anatomical improvement according to POP-Q Score
Measured: 2 years
Anatomical improvement according to POP-Q Score
Measured: 3 years
Secondary outcomes (11)
Hospital data:operative time
Measured: At discharge, an expected average of 5 days after operation.
Presence/absence of complications (composite score).
The occurrence (in the per-operative phase or within 6 weeks post-op) of at least one of the following: 1) bleeding complications; 2) infectious complications; 3) any wound caused by a surgeon movement: bladder, ureteral, or vascular injuries; 4)medical complications: deep vein thrombosis, pulmonary embolism and etc.Complications will be categorized using the Dindo surgical complication grading scale.
Measured: up to 6 weeks
Change from baseline in PFIQ-7 scores.
Measured: 6 months, 1 year, 2 year, 3 year
Change from baseline in PFDI-21 scores.
Measured: 6 months, 1 year, 2 year, 3 year
In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline)
Measured: 6 months, 1 year, 2 year, 3 year
Subject global impression assessed on a 5 point Likert scale
Measured: 6 months, 1 year, 2 year, 3 year
Presence/absence of complications (composite score)
Long-term negative outcomes of the surgical procedure will also be recorded until 3 years after surgery. For example, mesh erosion, de novo urinary incontinence, de novo dyspareunia and overall failure rate. Complications will be categorized using the Dindo surgical complication grading scale.
Measured: up to 3 years
hospital data: estimated blood loss
Measured: At discharge, an expected average of 5 days after operation.
hospital data:length of stay
Measured: At discharge, an expected average of 5 days after operation.
hospital data: postoperative morbidity
Measured: At discharge, an expected average of 5 days after operation.
hospital data: time to recovery
Measured: At discharge, an expected average of 5 days after operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan Zhu, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762384
- Sponsor's protocol ID
- pumch-gyn-05
- Status last verified
- Dec 2012
- First submitted
- 30 Dec 2012
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nationwide Multicenter Randomized Prospective Study to Compare Laparoscopic Sacral Colpopexy and Modified Total Pelvic Floor Reconstructive Surgery With Mesh for Apical Prolapse Stage III-IV
- ClinicalTrials.gov ID
- NCT01762384
- Acronym / sponsor ID
- pumch-gyn-05
- Conditions
- Uterine Prolapse, Vault Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Jan 2013 (estimated)
- 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 (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with patient's sex life. The primary treatment is surgery. Sacral Colpopexy is the gold standard procedure. Now it could be done laparoscopically. Modified total pelvic floor reconstructive surgery with mesh is developed in China for Asian Women.
This study is designed to determine the effectiveness and safety of Modified total pelvic floor reconstructive surgery with mesh compared with laparoscopic Sacral Colpopexy for the treatment of uterine or vault prolapse Stage III-IV.
Patients enrolled into the study will be followed up for up to 3 years after surgery. Evaluation will take place during surgery and postoperative visit. Stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates will be evaluated.
Detailed description
Pelvic organ prolapse is a common problem. The high rate of failure has led to an increasing use of synthetic grafts to augment vaginal repair procedures to obtain more durable results. In 2005, the investigators began to perform modified pelvic floor reconstruction surgery with mesh. The nation-wide multicenter prospective clinical trial data showed that it was safe, efficient and cost-effective. No severe intraoperative complications were recorded and the recurrence rate after 1 year follow-up was 8.1%. Quality of life improved significantly from the baseline, while the sexual function did not change.
Sacral colpopexy has long been regarded as the gold standard. Laparoscopic sacral colpopexy could offer durable result and low morbidity compared with open procedure.
In clinical practice, many women have symptomatic POP-Q Stage III-IV uterine or vault prolapse, which requires surgical correction. The aim of this multicenter, prospective and randomized study is to evaluate the effectiveness and safety of these two procedures in the treatment of symptomatic apical prolapse Stage III-IV in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSC | Active comparator | Procedure: LSC, Device: "Gynemesh"procedure: laparoscopic sacral colpopexy. |
| Modified PFRS | Active comparator | Procedure: modified PFRS, Device: "Gynemesh"procedure: modified pelvic floor reconstructive surgery with mesh. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Candidates with symptomatic uterine or vault prolapse of Stage III-IV, suitable for surgical repair.
- Age from 55-65 years old.
- Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires.
Key exclusion criteria (11 listed)
- Patients who could not tolerate laparoscopic surgery.
- Previous repair of pelvic organ prolapse involving insertion of mesh.
- Experimental drug or experimental medical device within 3 months prior to the planned procedure.
- Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
- Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
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 |
|---|---|---|
| LSCsubjects of this group are submitted to surgical treatment of laparoscopic sacral colpopexy. | Procedure or surgery | LSC |
| modified PFRSsubjects of this group are submitted to modified pelvic floor reconstructive surgery with mesh. | Procedure or surgery | Modified PFRS |
| "Gynemesh"Both surgeries will be conducted using mesh constructed from polypropylene mesh. | Device | LSC, Modified PFRS |
Primary outcome
anatomical improvement according to POP-Q score
Time frame: 6 months
Anatomical improvement according to POP-Q Score
Time frame: 1 year
Anatomical improvement according to POP-Q Score
Time frame: 2 years
Anatomical improvement according to POP-Q Score
Time frame: 3 years
11 secondary outcomes
Hospital data:operative time
Time frame: At discharge, an expected average of 5 days after operation.
Presence/absence of complications (composite score).
Time frame: up to 6 weeks
Change from baseline in PFIQ-7 scores.
Time frame: 6 months, 1 year, 2 year, 3 year
Change from baseline in PFDI-21 scores.
Time frame: 6 months, 1 year, 2 year, 3 year
In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline)
Time frame: 6 months, 1 year, 2 year, 3 year
Subject global impression assessed on a 5 point Likert scale
Time frame: 6 months, 1 year, 2 year, 3 year
Presence/absence of complications (composite score)
Time frame: up to 3 years
hospital data: estimated blood loss
Time frame: At discharge, an expected average of 5 days after operation.
hospital data:length of stay
Time frame: At discharge, an expected average of 5 days after operation.
hospital data: postoperative morbidity
Time frame: At discharge, an expected average of 5 days after operation.
hospital data: time to recovery
Time frame: At discharge, an expected average of 5 days after operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LSC, modified PFRS and "Gynemesh" in people with Uterine Prolapse and Vault Prolapse, run by Peking Union Medical College Hospital at 4 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 3 inclusion and 11 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 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 (86-13911714696, zhu_julie@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anatomical improvement according to POP-Q score (time frame: 6 months). The study lists 4 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 7 Jan 2013.