Pelvic Organ ProlapseNCT01396122
Clinical Performance of GYNECARE PROSIMA* Pelvic Floor Repair System for Symptomatic Pelvic Organ Prolapse
A study testing Procedure: GYNECARE PROSIMA* Pelvic Floor Repair System in people with Pelvic Organ Prolapse and Stage II-III, run by Peking Union Medical College Hospital at 25 sites in China.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Device in Women with Symptomatic Pelvic Organ Prolapse. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Stage II-III
- What is being tested?
- Procedure: GYNECARE PROSIMA* Pelvic Floor Repair System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 25 sitesChina
- Study dates
- Mar 2011to Mar 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair. Vaginal hysterectomy and mid-urethral sling procedures for incontinence may be performed concurrently.
- Age ≥ 18 years.
- Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee approved informed consent.
Who cannot join
- Additional surgical intervention concurrent to the procedure (e.g. sacrocolpopexy, paravaginal repair, tubal sterilisation).
- Previous repair of pelvic organ prolapse involving insertion of mesh.
- Previous hysterectomy within 6 months of scheduled surgery.
- 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.
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- 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).
- 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
25 sites in 1 country.
25 sites in 1 country
China25 sites, 11 recruiting
- Recruiting
Beijing Chaoyang Hospital Affiliated to Capital University of Medical Sciences
Beijing, 100020
Zhenyu Zhang, 86-13801237287, Zhenyuzhang2000@yahoo.com
Hong Wang, 86-13683690370
- Recruiting
The First Affiliated Hospital of Chinese PLA General Hospital
Beijing, 100048
Yong-xian Lu, 86-13520476024, Yongxianlu@sina.com
Yong-xina Lu
- Active, not recruiting
Beijing Hospital
Beijing, 100730
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Lan Zhu, 86-10-65296238, zhu_julie@vip.sina.com
Juan Chen, 86-13521354364, pumchcj@sina.com
- Recruiting
The Second Hospital of Xiangya,Central South University
Changsha, Hunan, 410011
Guang-shi Tao, 86-13574850167, taoguangshi@yahoo.com.cn
Guang-shi Tao
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Hong Shen, 86-18980601433, shen1177@163.com
Hong Shen
- Active, not recruiting
West China Second Hospital of Sichuan University
Chengdu, Sichuan, 610041
- Active, not recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
- Active, not recruiting
The Fifth People' Hospital of Chengdu
Chengdu, Sichuan, 611130
- Active, not recruiting
The First Hospital of Chongqing Medical University
Chongqin, 400016
- Not yet recruiting
The First People's Hospital of Foshan
Foshan, Guangdong, 528000
Gang Wang, 86-13929928768, Wallace1971@163.com
Gang Wang
- Active, not recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
- Active, not recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
- Active, not recruiting
The First Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
- Active, not recruiting
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510120
- Active, not recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
- Active, not recruiting
The Second Affiliated Hospital, Shandong University
Jinan, Shandong, 250033
- Recruiting
Mianyang Central Hospital
Mianyang, Sichuan, 621000
Yong Zhang, 86-13808110138, Zhangyong1215@gmail.com
Yong Zhang
- Active, not recruiting
The First Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, 210006
- Recruiting
Affiliated Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Zhi-jun Xia, 86-13840118800, xiazhijunhosp2@sina.com
Qing Hu, 86-18940255559, huq@sj-hospital.org
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Rui-fang Wu, 86-13827433039, Wurf100@126.com
Huan Li, 86-13828700921, szbdlh@163.com
- Active, not recruiting
The People's Hospital of Hubei Provincial
Wuhan, Hubei, 430060
- Active, not recruiting
The Third Hospital of Wuhan
Wuhan, Hubei, 430060
- Recruiting
Wuxi Maternal and Child Health Hospital, Nanjing Medical University
Wuxi, Jiangsu, 214002
Jian Gong, 86-13812074116, gongjianwx@126.com
Jian Gong
- Recruiting
Xiamen First Hospital Affiliated to Xiamen University
Xiamen, Fujian, 361004
Na-xuan Qiu, 13906011647, qnx1106@sina.com
Na-xuan Qiu
About this study
Official title: A Prospective, Multicenter Study to Evaluate the Clinical Performance of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Procedure for Symptomatic POP-Q Stage II-III Pelvic Organ Prolapse
The purpose of this study is to evaluate the safety and effectiveness of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Device in Women with Symptomatic Pelvic Organ Prolapse.
Read the detailed description
The GYNECARE PROSIMA* system is a new technique and now available in China. It provides a simplified unanchored mesh repair, making surgery much simpler to perform and reduces the risk of the specific complications that may occur when tunneling devices beyond the pelvic cavity.
In clinical practice, many women have symptomatic prolapse, which requires surgical correction. They are relatively young, and therefore care more about the long-term outcomes and quality of life after procedure. The purpose of this multicenter and prospective study is to evaluate the effectiveness and safety of the GYNECARE PROSIMA* system in the treatment of symptomatic POP-Q Stage II-III pelvic organ prolapse.
- Conditions
- Pelvic Organ Prolapse, Stage II-III
- Being tested
- Procedure: GYNECARE PROSIMA* Pelvic Floor Repair 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.
Procedure: GYNECARE PROSIMA* Pelvic Floor Repair SystemProcedure or surgery
Perform surgery with GYNECARE PROSIMA* Pelvic Floor Repair System. Vaginal hysterectomy or mid-urethral sling procedure for incontinence could be performed concurrently.
| Study group | Role | What they receive |
|---|---|---|
| PROSIMA group | Experimental | Reconstructive surgeries with GYNECARE PROSIMA* were performed in all patients. Receives: Procedure: Procedure: GYNECARE PROSIMA* Pelvic Floor Repair System |
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: 4 weeks
Anatomical improvement according to POP-Q score.
Measured: 6 months
Anatomical improvement according to POP-Q score.
Measured: 12 months
Anatomical improvement according to POP-Q score.
Measured: 2 years
Anatomical improvement according to POP-Q score.
Measured: 3 years
Secondary outcomes (9)
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 after surgery and postoperation visit at the 3-4 weeks.
Discomfort of balloon removal, measured using VAS at time of removal.
Measured: 24 hours after surgery.
Subject discomfort of VSD by VAS.
Measured: postoperation visit at 3-4 weeks.
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, 12 months, 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: 6 months, 12 months, 2 years and 3 years.
Subject global impression assessed on a 5 point Likert scale.
Measured: 6 months, 12 months, 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 posted18 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2016 (estimated)
- Study completionMar 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT01396122
- Sponsor's protocol ID
- pumch-gyn-02
- Status last verified
- Jul 2011
- First submitted
- 13 Jul 2011
- Last updated
- 27 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study to Evaluate the Clinical Performance of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Procedure for Symptomatic POP-Q Stage II-III Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT01396122
- Acronym / sponsor ID
- pumch-gyn-02
- Conditions
- Pelvic Organ Prolapse, Stage II-III
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 18 Jul 2011 (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.
The purpose of this study is to evaluate the safety and effectiveness of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Device in Women with Symptomatic Pelvic Organ Prolapse.
Detailed description
The GYNECARE PROSIMA* system is a new technique and now available in China. It provides a simplified unanchored mesh repair, making surgery much simpler to perform and reduces the risk of the specific complications that may occur when tunneling devices beyond the pelvic cavity.
In clinical practice, many women have symptomatic prolapse, which requires surgical correction. They are relatively young, and therefore care more about the long-term outcomes and quality of life after procedure. The purpose of this multicenter and prospective study is to evaluate the effectiveness and safety of the GYNECARE PROSIMA* system in the treatment of symptomatic POP-Q Stage II-III pelvic organ prolapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PROSIMA group | Experimental | Procedure: Procedure: GYNECARE PROSIMA* Pelvic Floor Repair SystemReconstructive surgeries with GYNECARE PROSIMA* were performed in all patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair. Vaginal hysterectomy and mid-urethral sling procedures for incontinence may be performed concurrently.
- Age ≥ 18 years.
- Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee approved informed consent.
Key exclusion criteria (13 listed)
- Additional surgical intervention concurrent to the procedure (e.g. sacrocolpopexy, paravaginal repair, tubal sterilisation).
- Previous repair of pelvic organ prolapse involving insertion of mesh.
- Previous hysterectomy within 6 months of scheduled surgery.
- 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.
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 |
|---|---|---|
| Procedure: GYNECARE PROSIMA* Pelvic Floor Repair SystemPerform surgery with GYNECARE PROSIMA* Pelvic Floor Repair System. Vaginal hysterectomy or mid-urethral sling procedure for incontinence could be performed concurrently. | Procedure or surgery | PROSIMA group |
Primary outcome
Anatomical improvement according to POP-Q score.
Time frame: 4 weeks
Anatomical improvement according to POP-Q score.
Time frame: 6 months
Anatomical improvement according to POP-Q score.
Time frame: 12 months
Anatomical improvement according to POP-Q score.
Time frame: 2 years
Anatomical improvement according to POP-Q score.
Time frame: 3 years
9 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 after surgery and postoperation visit at the 3-4 weeks.
Discomfort of balloon removal, measured using VAS at time of removal.
Time frame: 24 hours after surgery.
Subject discomfort of VSD by VAS.
Time frame: postoperation visit at 3-4 weeks.
Presence/absence of complications (composite score)
Time frame: Up to 6 weeks.
Change from baseline in PFIQ-7 scores.
Time frame: 6 months, 12 months, 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: 6 months, 12 months, 2 years and 3 years.
Subject global impression assessed on a 5 point Likert scale.
Time frame: 6 months, 12 months, 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 27 Dec 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.
Lan Zhu principal investigator
Peking Union Medical College Hospital
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: GYNECARE PROSIMA* Pelvic Floor Repair System in people with Pelvic Organ Prolapse and Stage II-III, run by Peking Union Medical College Hospital at 25 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 13 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 27 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 (86-10-65296238, zhu_julie@vip.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: 4 weeks). The study lists 5 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 27 Dec 2012.