Uterine ProlapseNCT01396109
GYNECARE PROSIMA* Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Uterine Prolapse Stage III
A study testing Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System and Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with mesh in people with Uterine Prolapse and Stage III, run by Peking Union Medical College Hospital at 10 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Uterine Prolapse, Stage III
- What is being tested?
- Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System and Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 10 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates with symptomatic uterine prolapse of ICS POP-Q Stage III(with any degree of vaginal prolapse), suitable for surgical repair.
- Vaginal hysterectomy will be performed concurrently.
- Without stress urinary incontinence or occult stress urinary incontinence with no need of mid-urethral sling procedures for incontinence to be performed.
- Age ≥ 60 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 / IRB 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.
- 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.
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- 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
10 sites in 1 country.
10 sites in 1 country
China10 sites, 7 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100191
Jin-song Han, Hanjinsong353@sina.com
Jin-song Han
- 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
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006
Hangmei Jin, jinhm@zju.edu.cn
Hang-mei Jin
- Active, not recruiting
Hefei Maternity and Child Health Hospital
Hefei, Anhui, 230001
- Recruiting
Laizhou Municipal People's Hospital
Laizhou, Shandong, 261400
Jie-liang Li, lzlijieliang@126.com
Jie-liang Li
- Recruiting
Gansu Maternity and Child Health Hospital
Lanzhou, Gansu, 730050
Qing Liu, gslzlq@yahoo.com.cn
Qing Liu
- Active, not recruiting
Maternal and Child Health Hospital of Jiangxi Province
Nanchang, Jiangxi, 330006
- Active, not recruiting
Hebei Provincial Hospital
Shijiazhuang, Hebei, 050051
- Recruiting
Wuxi Maternal and Child Health Hospital, Nanjing Medical University
Wuxi, Jiangsu, 214002
Jian Gong, gongjianwx@126.com
Jian Gong
- Recruiting
the First Affliliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Mei Ji, Jimei0821@yahoo.com.cn
Mei Ji
About this study
Official title: A Prospective, Multicenter Trial to Compare GYNECARE PROSIMA* Pelvic Floor Repair System Procedure With Modified Total Pelvic Floor Reconstruction Surgery Concomitantly With TVH to Treat Symptomatic POP-Q Stage III Uterine Prolapse
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, sometimes a mesh is placed in the pelvis to support the weakened tissues, but mesh implants can cause complications.
This study is designed to determine the effectiveness and safety of GYNECARE PROSIMA* pelvic floor repair system compared with the modified total pelvic floor reconstructive surgery with mesh for the treatment of uterine prolapse.
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.
The GYNECARE PROSIMA* system is a new technique. It provides a simplified unanchored mesh repair, avoiding the need for dissection outside the pelvic cavity and avoids passage of suture and instruments through the obturator foramen and sacrospinous ligament, thus making surgery much simpler to perform and reduces the risk of the specific complications that can occur with suture placement or tunneling. 1-year anatomic and functional outcomes of international multicenter prospective study for POP-Q Stage I I-III pelvic organ prolapse showed the objective success rate was 76.9%, pelvic symptoms, quality of life, and sexual function improved significantly from baseline.
In clinical practice, many women have symptomatic POP-Q Stage III uterine 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, prospective, and comparative study is to evaluate the effectiveness and safety of these two procedures concomitantly performed with vaginal hysterectomy (TVH) in the treatment of symptomatic POP-Q Stage III uterine prolapse in China.
- Conditions
- Uterine Prolapse, Stage III
- Being tested
- Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System, Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with mesh
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair SystemProcedure or surgery
Subjects of this group were submitted to surgical treatment with GYNECARE PROSIMA* Pelvic Floor Repair System concurrently with transvaginal hysterectomy.
Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with meshProcedure or surgery
Subjects of this group were submitted to surgical treatment of Modified Pelvic Floor Reconstruction Surgery with mesh concurrently with transvaginal hysterectomy.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Intervention: Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System Receives: Procedure: Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System |
| Group II | Active comparator | Intervention: Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with Mesh Receives: Procedure: Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with mesh |
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 (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 3-4 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: 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 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT01396109
- Sponsor's protocol ID
- pumch-gyn-01
- Status last verified
- Mar 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 Trial to Compare GYNECARE PROSIMA* Pelvic Floor Repair System Procedure With Modified Total Pelvic Floor Reconstruction Surgery Concomitantly With TVH to Treat Symptomatic POP-Q Stage III Uterine Prolapse
- ClinicalTrials.gov ID
- NCT01396109
- Acronym / sponsor ID
- pumch-gyn-01
- Conditions
- Uterine Prolapse, Stage III
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 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.
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, sometimes a mesh is placed in the pelvis to support the weakened tissues, but mesh implants can cause complications.
This study is designed to determine the effectiveness and safety of GYNECARE PROSIMA* pelvic floor repair system compared with the modified total pelvic floor reconstructive surgery with mesh for the treatment of uterine prolapse.
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.
The GYNECARE PROSIMA* system is a new technique. It provides a simplified unanchored mesh repair, avoiding the need for dissection outside the pelvic cavity and avoids passage of suture and instruments through the obturator foramen and sacrospinous ligament, thus making surgery much simpler to perform and reduces the risk of the specific complications that can occur with suture placement or tunneling. 1-year anatomic and functional outcomes of international multicenter prospective study for POP-Q Stage I I-III pelvic organ prolapse showed the objective success rate was 76.9%, pelvic symptoms, quality of life, and sexual function improved significantly from baseline.
In clinical practice, many women have symptomatic POP-Q Stage III uterine 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, prospective, and comparative study is to evaluate the effectiveness and safety of these two procedures concomitantly performed with vaginal hysterectomy (TVH) in the treatment of symptomatic POP-Q Stage III uterine prolapse 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 |
|---|---|---|
| Group I | Active comparator | Procedure: Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair SystemIntervention: Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System |
| Group II | Active comparator | Procedure: Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with meshIntervention: Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with Mesh |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Candidates with symptomatic uterine prolapse of ICS POP-Q Stage III(with any degree of vaginal prolapse), suitable for surgical repair.
- Vaginal hysterectomy will be performed concurrently.
- Without stress urinary incontinence or occult stress urinary incontinence with no need of mid-urethral sling procedures for incontinence to be performed.
- Age ≥ 60 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 / IRB approved informed consent.
Key exclusion criteria (12 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.
- 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 |
|---|---|---|
| Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair SystemSubjects of this group were submitted to surgical treatment with GYNECARE PROSIMA* Pelvic Floor Repair System concurrently with transvaginal hysterectomy. | Procedure or surgery | Group I |
| Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with meshSubjects of this group were submitted to surgical treatment of Modified Pelvic Floor Reconstruction Surgery with mesh concurrently with transvaginal hysterectomy. | Procedure or surgery | Group II |
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
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 3-4 week visit
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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System and Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with mesh in people with Uterine Prolapse and Stage III, run by Peking Union Medical College Hospital at 10 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 5 inclusion and 12 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 10 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.