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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Active Comparator | Intervention: Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System |
|
| Group II | Active Comparator | Intervention: Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with Mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System | Procedure | Subjects of this group were submitted to surgical treatment with GYNECARE PROSIMA* Pelvic Floor Repair System concurrently with transvaginal hysterectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Anatomical improvement according to POP-Q score. | 4 weeks | |
| Anatomical improvement according to POP-Q score. | 6 months | |
| Anatomical improvement according to POP-Q score. | 12 months | |
| Anatomical improvement according to POP-Q score. | 2 years | |
| Anatomical improvement according to POP-Q score. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital data including operative time, estimated blood loss, length of stay, maximum temperature, time of voiding recovery. | At discharge, an expected average of 5 days after operation. | |
| Pain score measured using Visual Analog Scale (VAS). | 24 hours post surgery and at the 3-4 week visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lan Zhu | Contact | 86-10-65296238 | zhu_julie@vip.sina.com | |
| Juan Chen | Contact | 86-13521354364 | pumchcj@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Lan Zhu | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hefei Maternity and Child Health Hospital | Active, not recruiting | Hefei | Anhui | 230001 | China | |
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| Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with mesh | Procedure | Subjects of this group were submitted to surgical treatment of Modified Pelvic Floor Reconstruction Surgery with mesh concurrently with transvaginal hysterectomy. |
|
| 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. | Up to 6 weeks. |
| Change from baseline in PFIQ-7 scores. | 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) | 6 months, 12 months, 2 years and 3 years. |
| Subject global impression assessed on a 5 point Likert scale | 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. | Up to 3 years. |
| Gansu Maternity and Child Health Hospital |
| Recruiting |
| Lanzhou |
| Gansu |
| 730050 |
| China |
|
| Hebei Provincial Hospital | Active, not recruiting | Shijiazhuang | Hebei | 050051 | China |
| the First Affliliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
|
| Wuxi Maternal and Child Health Hospital, Nanjing Medical University | Recruiting | Wuxi | Jiangsu | 214002 | China |
|
| Maternal and Child Health Hospital of Jiangxi Province | Active, not recruiting | Nanchang | Jiangxi | 330006 | China |
| Laizhou Municipal People's Hospital | Recruiting | Laizhou | Shandong | 261400 | China |
|
| Women's Hospital School of Medicine Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310006 | China |
|
| Peking University Third Hospital | Recruiting | Beijing | 100191 | China |
|
| Peking Union Medical College Hospital | Recruiting | Beijing | 100730 | China |
|
| ID | Term |
|---|---|
| D014596 | Uterine Prolapse |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009074 | Melanocyte-Stimulating Hormones |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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