Pelvic Organ ProlapseNCT01670682
Ischia Spinous Fascia Fixation Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Pelvic Organ Prolapse Stage III
A study testing ischia spinous fascia fixation, Modified Pelvic Floor Reconstruction Surgery with Mesh and polypropylene mesh(Gynemesh) in people with Pelvic Organ Prolapse, run by Peking Union Medical College Hospital at 5 sites in China.
Trial summary
Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous fascia fixation procedure and modified total pelvic floor reconstructive surgery with mesh are both developed in China for vaginal apex fixation, the former is native tissue repairs, and the latter is augmentation with mesh. Read more about this study
- Who is it for?
- Ages 55 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- ischia spinous fascia fixation, Modified Pelvic Floor Reconstruction Surgery with Mesh and polypropylene mesh(Gynemesh)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesChina
- Study dates
- Aug 2012to Aug 2016
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates with symptomatic pelvic organ prolapse of POP-Q Stage III, suitable for surgical repair.
- Vaginal hysterectomy and anti-incontinence procedures could be performed concurrently.
- Age ≥ 55 years.
- Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires.
Who cannot join
- 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
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Juan Chen, 13521354364, pumchcj@sina.com
- Recruiting
Foshan Maternal and Child Health Hospital
Foshan, Guangdong, 528000
Yuling Wang, 13049161630, Wujun701121@126.com
- Recruiting
Affiliated Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Zhijun Xia, 13840118800, xiazhijunhosp2@sina.com
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Huan Li, 13828700921, szbdlh@163.com
- Recruiting
the Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Luwen Wang, 13607683293, Wangluwen_688@sohu.com
About this study
Official title: A Prospective，Multicenter Pilot Study to Compare Ischia Spinous Fascia Fixation Procedure With Modified Total Pelvic Floor Reconstruction Surgery For Pelvic Organ Prolapse Stage III
Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous fascia fixation procedure and modified total pelvic floor reconstructive surgery with mesh are both developed in China for vaginal apex fixation, the former is native tissue repairs, and the latter is augmentation with mesh.
This study is designed to determine the effectiveness and safety of ischia spinous fascia fixation procedure compared with modified total pelvic floor reconstructive surgery with mesh for the treatment of pelvic organ prolapse stage III.
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 (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. An ideal procedure for vaginal apical support should provide a durable suspension, have minimal complications, and not affect sexual or visceral function.
Vaginal procedures used for restoring the vaginal apex support include Ischia spinous fascia fixation procedure with native tissue and modified total pelvic floor reconstructive surgery with mesh. They are both developed and popular in China. Clinical practice showed that they were both safe, efficient and cost-effective. Recurrent rates of both procedures after 1 year follow-up were about 10%, and quality of life improved significantly from the baseline, while the.complications are different.
The purpose of this multicenter, prospective, and comparative study is to evaluate the effectiveness and safety of these two procedures in the treatment of symptomatic pelvic organ prolapse Stage III in China.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- ischia spinous fascia fixation, Modified Pelvic Floor Reconstruction Surgery with Mesh, polypropylene mesh(Gynemesh)
- Keywords
- Stage III
- 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.
ischia spinous fascia fixationProcedure or surgery
Subjects of this group were submitted to surgical treatment with ischia spinous fascia fixation.
Modified Pelvic Floor Reconstruction Surgery with MeshProcedure or surgery
Subjects of this group were submitted to surgical treatment with Modified Total Pelvic Floor Reconstruction Surgery with Mesh.
polypropylene mesh(Gynemesh)Device
Pelvic floor reconstruction will be conducted using surgical mesh made from polypropylene.
| Study group | Role | What they receive |
|---|---|---|
| fascia fixation group | Active comparator | procedure: ischia spinous fascia fixation Receives: Procedure: ischia spinous fascia fixation |
| mesh group | Active comparator | Procedure: Modified Pelvic Floor Reconstruction Surgery with mesh Receives: Procedure: Modified Pelvic Floor Reconstruction Surgery with Mesh; Device: polypropylene mesh(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 weeks
•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 (7)
•Hospital data including operative time, estimated blood loss, length of stay, maximum temperature, time of voiding recovery.
Measured: At discharge, an expected average of 5 days after operation.
•Pain score measured using Visual Analog Scale (VAS).
Measured: 24 hours post surgery and at the 6-week visit
•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: 1 year, 2 years and 3 years.
•In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline)
Measured: 1 year, 2 years and 3 years.
•Subject global impression assessed on a 5 point Likert scale
Measured: 1 year, 2 years and 3 years.
•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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670682
- Sponsor's protocol ID
- pumch-gyn-03
- Status last verified
- Aug 2012
- First submitted
- 22 Feb 2012
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective，Multicenter Pilot Study to Compare Ischia Spinous Fascia Fixation Procedure With Modified Total Pelvic Floor Reconstruction Surgery For Pelvic Organ Prolapse Stage III
- ClinicalTrials.gov ID
- NCT01670682
- Acronym / sponsor ID
- pumch-gyn-03
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Stage III
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 22 Aug 2012 (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 is a common problem. The primary treatment is surgery. Ischia spinous fascia fixation procedure and modified total pelvic floor reconstructive surgery with mesh are both developed in China for vaginal apex fixation, the former is native tissue repairs, and the latter is augmentation with mesh.
This study is designed to determine the effectiveness and safety of ischia spinous fascia fixation procedure compared with modified total pelvic floor reconstructive surgery with mesh for the treatment of pelvic organ prolapse stage III.
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 (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. An ideal procedure for vaginal apical support should provide a durable suspension, have minimal complications, and not affect sexual or visceral function.
Vaginal procedures used for restoring the vaginal apex support include Ischia spinous fascia fixation procedure with native tissue and modified total pelvic floor reconstructive surgery with mesh. They are both developed and popular in China. Clinical practice showed that they were both safe, efficient and cost-effective. Recurrent rates of both procedures after 1 year follow-up were about 10%, and quality of life improved significantly from the baseline, while the.complications are different.
The purpose of this multicenter, prospective, and comparative study is to evaluate the effectiveness and safety of these two procedures in the treatment of symptomatic pelvic organ prolapse Stage III in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fascia fixation group | Active comparator | Procedure: ischia spinous fascia fixationprocedure: ischia spinous fascia fixation |
| mesh group | Active comparator | Procedure: Modified Pelvic Floor Reconstruction Surgery with Mesh, Device: polypropylene mesh(Gynemesh)Procedure: Modified Pelvic Floor Reconstruction Surgery with mesh |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Candidates with symptomatic pelvic organ prolapse of POP-Q Stage III, suitable for surgical repair.
- Vaginal hysterectomy and anti-incontinence procedures could be performed concurrently.
- Age ≥ 55 years.
- Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| ischia spinous fascia fixationSubjects of this group were submitted to surgical treatment with ischia spinous fascia fixation. | Procedure or surgery | fascia fixation group |
| Modified Pelvic Floor Reconstruction Surgery with MeshSubjects of this group were submitted to surgical treatment with Modified Total Pelvic Floor Reconstruction Surgery with Mesh. | Procedure or surgery | mesh group |
| polypropylene mesh(Gynemesh)Pelvic floor reconstruction will be conducted using surgical mesh made from polypropylene. | Device | mesh group |
Primary outcome
•Anatomical improvement according to POP-Q score.
Time frame: 6 weeks
•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
7 secondary outcomes
•Hospital data including operative time, estimated blood loss, length of stay, maximum temperature, time of voiding recovery.
Time frame: At discharge, an expected average of 5 days after operation.
•Pain score measured using Visual Analog Scale (VAS).
Time frame: 24 hours post surgery and at the 6-week visit
•Presence/absence of complications (composite score).
Time frame: Up to 6 weeks.
•Change from baseline in PFIQ-7 scores.
Time frame: 1 year, 2 years and 3 years.
•In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline)
Time frame: 1 year, 2 years and 3 years.
•Subject global impression assessed on a 5 point Likert scale
Time frame: 1 year, 2 years and 3 years.
•Presence/absence of complications (composite score)
Time frame: Up to 3 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2012.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ischia spinous fascia fixation, Modified Pelvic Floor Reconstruction Surgery with Mesh and polypropylene mesh(Gynemesh) in people with Pelvic Organ Prolapse, run by Peking Union Medical College Hospital at 5 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 4 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 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 (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 weeks). 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 22 Aug 2012.