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Efficacy and Safety of Reduced Pelvic Floor Mesh Implants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01739374
First Posted: December 3, 2012
Last Update Posted: June 18, 2015
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.
Information provided by (Responsible Party):
menahem neuman, Western Galilee Hospital-Nahariya
  Purpose
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.

Condition Intervention Phase
Post Operative Pain Complication of Surgical Procedure Other: reduced mesh implants Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2-3 Study of Efficacy and Safety of Reduced Pelvic Floor Mesh Implants

Further study details as provided by menahem neuman, Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • Intra-operative and post operative adverse effects [ Time Frame: One year post operative ]
    Vaginal and pelvic pain upon VAS, vaginal mesh exposure, infections.


Secondary Outcome Measures:
  • Efficacy [ Time Frame: One year ]
    Pelvic organ prolapse reconstruction upon the International Continence Society Pelvic Organ Prolapse Quantification System measurements


Enrollment: 100
Study Start Date: May 2013
Study Completion Date: March 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device - Reduced mesh implants
Patients treated with reduced mesh implants for POP reconstruction
Other: reduced mesh implants
mesh for pelvic floor reinforcement

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-Patients with advanced pelvic organ prolapse

Exclusion Criteria:

- Patients with active infections or after pelvic irradiation

  Contacts and Locations
Information from the National Library of Medicine

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): NCT01739374


Locations
Israel
Western Galilee MC
Nahariya, Israel, 22110
Ob-Gyn Dep., Western Galilee MC
Nahariya, Israel, 65742
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Investigators
Principal Investigator: Menahem Neuman, Prof. Faculty of Medicine, Bar-Ilan Univ., Zafed
  More Information

Responsible Party: menahem neuman, Primary Investigator, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT01739374     History of Changes
Other Study ID Numbers: HTA5969
24411 ( Other Identifier: Local IRB )
First Submitted: November 22, 2012
First Posted: December 3, 2012
Last Update Posted: June 18, 2015
Last Verified: June 2015

Keywords provided by menahem neuman, Western Galilee Hospital-Nahariya:
pelvic floor reconstruction
mesh implants

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms