GYNECARE PROSIMA* Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Uterine Prolapse Stage III

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2011 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01396109
First received: July 13, 2011
Last updated: December 25, 2012
Last verified: March 2011
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Anatomical improvement according to POP-Q score. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Anatomical improvement according to POP-Q score. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Anatomical improvement according to POP-Q score. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Anatomical improvement according to POP-Q score. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Anatomical improvement according to POP-Q score. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
  • Pain score measured using Visual Analog Scale (VAS). [ Time Frame: 24 hours post surgery and at the 3-4 week visit ] [ Designated as safety issue: Yes ]
  • Presence/absence of complications (composite score). [ Time Frame: Up to 6 weeks. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Subject global impression assessed on a 5 point Likert scale [ Time Frame: 6 months, 12 months, 2 years and 3 years. ] [ Designated as safety issue: No ]
  • Presence/absence of complications (composite score) [ Time Frame: Up to 3 years. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: March 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396109

Contacts
Contact: Lan Zhu 86-10-65296238 zhu_julie@vip.sina.com
Contact: Juan Chen 86-13521354364 pumchcj@sina.com

Locations
China, Anhui
Hefei Maternity and Child Health Hospital Active, not recruiting
Hefei, Anhui, China, 230001
China, Gansu
Gansu Maternity and Child Health Hospital Recruiting
Lanzhou, Gansu, China, 730050
Contact: Qing Liu       gslzlq@yahoo.com.cn   
Principal Investigator: Qing Liu         
China, Hebei
Hebei Provincial Hospital Active, not recruiting
Shijiazhuang, Hebei, China, 050051
China, Henan
the First Affliliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Mei Ji       Jimei0821@yahoo.com.cn   
Principal Investigator: Mei Ji         
China, Jiangsu
Wuxi Maternal and Child Health Hospital, Nanjing Medical University Recruiting
Wuxi, Jiangsu, China, 214002
Contact: Jian Gong       gongjianwx@126.com   
Principal Investigator: Jian Gong         
China, Jiangxi
Maternal and Child Health Hospital of Jiangxi Province Active, not recruiting
Nanchang, Jiangxi, China, 330006
China, Shandong
Laizhou Municipal People's Hospital Recruiting
Laizhou, Shandong, China, 261400
Contact: Jie-liang Li       lzlijieliang@126.com   
Principal Investigator: Jie-liang Li         
China, Zhejiang
Women's Hospital School of Medicine Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Hangmei Jin       jinhm@zju.edu.cn   
Principal Investigator: Hang-mei Jin         
China
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    zhu_julie@vip.sina.com   
Contact: Juan Chen    86-13521354364    pumchcj@sina.com   
Principal Investigator: Lan Zhu         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Lan Zhu Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01396109     History of Changes
Other Study ID Numbers: pumch-gyn-01
Study First Received: July 13, 2011
Last Updated: December 25, 2012
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse

ClinicalTrials.gov processed this record on July 22, 2014