Efficacy and Safety of Reduced Pelvic Floor Mesh Implants
Primary Purpose
Post Operative Pain, Complication of Surgical Procedure
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
reduced mesh implants
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain focused on measuring pelvic floor reconstruction, mesh implants
Eligibility Criteria
Inclusion Criteria:
-Patients with advanced pelvic organ prolapse
Exclusion Criteria:
- Patients with active infections or after pelvic irradiation
Sites / Locations
- Western Galilee MC
- Ob-Gyn Dep., Western Galilee MC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Device - Reduced mesh implants
Arm Description
Patients treated with reduced mesh implants for POP reconstruction
Outcomes
Primary Outcome Measures
Intra-operative and post operative adverse effects
Vaginal and pelvic pain upon VAS, vaginal mesh exposure, infections.
Secondary Outcome Measures
Efficacy
Pelvic organ prolapse reconstruction upon the International Continence Society Pelvic Organ Prolapse Quantification System measurements
Full Information
NCT ID
NCT01739374
First Posted
November 22, 2012
Last Updated
June 17, 2015
Sponsor
Western Galilee Hospital-Nahariya
1. Study Identification
Unique Protocol Identification Number
NCT01739374
Brief Title
Efficacy and Safety of Reduced Pelvic Floor Mesh Implants
Official Title
Phase 2-3 Study of Efficacy and Safety of Reduced Pelvic Floor Mesh Implants
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Galilee Hospital-Nahariya
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pelvic organ prolapse is an herniation process, needing a mesh reconstruction for long lasting therapeutic effect. Yet, mesh implants were reported to be related to severe adverse effects. This study looks at the potential benefit of mesh size reduction regarding avoiding operative complications.
Detailed Description
Pelvic organ prolapse is a common disorder that results in significant patient morbidity. Approximately 1 in 9 women undergo surgery for the correction of pelvic organ prolapse (POP) and associated bladder and bowel dysfunction. Despite its common occurrence, the cause of POP remains largely unknown. Prolapse is thought to be caused by direct injury to the levator ani (LA) muscle, denervation of the pelvic floor musculature, or fascial damage incurred during childbirth trauma.
It is evident that pelvic organ prolapse (POP) occurs when the supporting pelvic floor becomes weakened or stretched, usually caused by childbirth, leading to descent of the pelvic organs to the vagina and beyond. This contributes to the impairment of pelvic organ function and a deterioration of patient quality of life. POP is estimated to severely affect approximately 11% of the female population.
Symptomatic POP patients might benefit from conservative management, such as the use of physiotherapy or vaginal pessaries. However, advanced POP necessitates surgical reconstruction. This might be achieved by the abdominal approach by an open operation or by laparoscopy, or by the vaginal approach. Synthetic permanent or absorbable meshes or biological grafts, or any synthesis of these might be used for reinforcement of the weakened pelvic floor structures that led to POP.
The need for reinforcement of the weakened fascia for achieving a long lasting cure of herniation processes is un-questionable. Given that the underlying pathology leading to POP is actually just a hernia of the pelvic floor, one must admit that the very same surgical principles used for any hernia repair are applicable for POP.
Most of the adverse effects are related to excessive implanted mesh mass. Thus, our goal with this study is to look at the issue of reducing the mesh size, surface area and the total mesh mass, assuming that the less quantity of left over implant the less mesh related complication will occur. The narrative for that is the notion that the natural pelvic floor connective tissue architecture is ligamentary and not "sheath like", while available pre-cut meshes are much too wide spread. This study concept is that reducing the mesh surface will lead to reduction with the mesh related complication. Given that the mesh implant size will be reduced, so will also be the wide of the extent of preliminary dissection, necessary for proper mesh placement. Thus, the dissection related adverse effects are expected to reduce as well.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Complication of Surgical Procedure
Keywords
pelvic floor reconstruction, mesh implants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device - Reduced mesh implants
Arm Type
Experimental
Arm Description
Patients treated with reduced mesh implants for POP reconstruction
Intervention Type
Other
Intervention Name(s)
reduced mesh implants
Intervention Description
mesh for pelvic floor reinforcement
Primary Outcome Measure Information:
Title
Intra-operative and post operative adverse effects
Description
Vaginal and pelvic pain upon VAS, vaginal mesh exposure, infections.
Time Frame
One year post operative
Secondary Outcome Measure Information:
Title
Efficacy
Description
Pelvic organ prolapse reconstruction upon the International Continence Society Pelvic Organ Prolapse Quantification System measurements
Time Frame
One year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-Patients with advanced pelvic organ prolapse
Exclusion Criteria:
- Patients with active infections or after pelvic irradiation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Menahem Neuman, Prof.
Organizational Affiliation
Faculty of Medicine, Bar-Ilan Univ., Zafed
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Galilee MC
City
Nahariya
ZIP/Postal Code
22110
Country
Israel
Facility Name
Ob-Gyn Dep., Western Galilee MC
City
Nahariya
ZIP/Postal Code
65742
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Reduced Pelvic Floor Mesh Implants
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