GYNECARE PROSIMA* Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Uterine Prolapse Stage III
NCT ID: NCT01396109
Last Updated: 2012-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2011-03-31
2016-03-31
Brief Summary
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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
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group I
Intervention: Procedure: TVH and GYNECARE PROSIMA\* Pelvic Floor Repair System
Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System
Subjects of this group were submitted to surgical treatment with GYNECARE PROSIMA\* Pelvic Floor Repair System concurrently with transvaginal hysterectomy.
Group II
Intervention: Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with Mesh
Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with mesh
Subjects of this group were submitted to surgical treatment of Modified Pelvic Floor Reconstruction Surgery with mesh concurrently with transvaginal hysterectomy.
Interventions
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Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System
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 mesh
Subjects of this group were submitted to surgical treatment of Modified Pelvic Floor Reconstruction Surgery with mesh concurrently with transvaginal hysterectomy.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
* 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.
60 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Lan Zhu
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Hefei Maternity and Child Health Hospital
Hefei, Anhui, China
Gansu Maternity and Child Health Hospital
Lanzhou, Gansu, China
Hebei Provincial Hospital
Shijiazhuang, Hebei, China
the First Affliliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Wuxi Maternal and Child Health Hospital, Nanjing Medical University
Wuxi, Jiangsu, China
Maternal and Child Health Hospital of Jiangxi Province
Nanchang, Jiangxi, China
Laizhou Municipal People's Hospital
Laizhou, Shandong, China
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China
Peking University Third Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Qing Liu
Role: primary
Mei Ji
Role: primary
Jian Gong
Role: primary
Jie-liang Li
Role: primary
Hangmei Jin
Role: primary
Jin-song Han
Role: primary
Lan Zhu
Role: primary
Juan Chen
Role: backup
Other Identifiers
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pumch-gyn-01
Identifier Type: -
Identifier Source: org_study_id