search
Back to results

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
Western Galilee Hospital-Nahariya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring pelvic floor reconstruction, mesh implants

Eligibility Criteria

35 Years - 95 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

First Posted
November 22, 2012
Last Updated
June 17, 2015
Sponsor
Western Galilee Hospital-Nahariya
search

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

We'll reach out to this number within 24 hrs