GYNECARE PROSIMA* Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Uterine Prolapse Stage III
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01396109|
Recruitment Status : Unknown
Verified March 2011 by Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : July 18, 2011
Last Update Posted : December 27, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Uterine Prolapse Stage III||Procedure: Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System Procedure: Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with mesh||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||March 2016|
Active Comparator: Group I
Intervention: Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System
Procedure: 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.
Active Comparator: Group II
Intervention: Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with Mesh
Procedure: 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.
- 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 ]
- 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. ]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.
- 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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396109
|Contact: Lan Zhuemail@example.com|
|Contact: Juan Chenfirstname.lastname@example.org|
|Hefei Maternity and Child Health Hospital||Active, not recruiting|
|Hefei, Anhui, China, 230001|
|Gansu Maternity and Child Health Hospital||Recruiting|
|Lanzhou, Gansu, China, 730050|
|Contact: Qing Liu email@example.com|
|Principal Investigator: Qing Liu|
|Hebei Provincial Hospital||Active, not recruiting|
|Shijiazhuang, Hebei, China, 050051|
|the First Affliliated Hospital of Zhengzhou University||Recruiting|
|Zhengzhou, Henan, China, 450052|
|Contact: Mei Ji Jimei0821@yahoo.com.cn|
|Principal Investigator: Mei Ji|
|Wuxi Maternal and Child Health Hospital, Nanjing Medical University||Recruiting|
|Wuxi, Jiangsu, China, 214002|
|Contact: Jian Gong firstname.lastname@example.org|
|Principal Investigator: Jian Gong|
|Maternal and Child Health Hospital of Jiangxi Province||Active, not recruiting|
|Nanchang, Jiangxi, China, 330006|
|Laizhou Municipal People's Hospital||Recruiting|
|Laizhou, Shandong, China, 261400|
|Contact: Jie-liang Li email@example.com|
|Principal Investigator: Jie-liang Li|
|Women's Hospital School of Medicine Zhejiang University||Recruiting|
|Hangzhou, Zhejiang, China, 310006|
|Contact: Hangmei Jin firstname.lastname@example.org|
|Principal Investigator: Hang-mei Jin|
|Peking University Third Hospital||Recruiting|
|Beijing, China, 100191|
|Contact: Jin-song Han Hanjinsong353@sina.com|
|Principal Investigator: Jin-song Han|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, China, 100730|
|Contact: Lan Zhu 86-10-65296238 email@example.com|
|Contact: Juan Chen 86-13521354364 firstname.lastname@example.org|
|Principal Investigator: Lan Zhu|
|Principal Investigator:||Lan Zhu||Peking Union Medical College Hospital|