Trial record 17 of 59 for:    Open Studies | "Pelvic Floor"

Efficacy and Safety of Reduced Pelvic Floor Mesh Implants

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Western Galilee Hospital-Nahariya
Sponsor:
Information provided by (Responsible Party):
menahem neuman, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT01739374
First received: November 22, 2012
Last updated: July 2, 2014
Last verified: April 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2-3 Study of Efficacy and Safety of Reduced Pelvic Floor Mesh Implants

Resource links provided by NLM:


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

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


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


Estimated Enrollment: 60
Study Start Date: May 2013
Estimated Study Completion Date: March 2016
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
Other Name: reduced mesh implants

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

Ages Eligible for Study:   35 Years to 95 Years
Genders 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
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: NCT01739374

Contacts
Contact: Menahem Neuman, Prof. +972-546-444-033 mneuman@netvision.net.il

Locations
Israel
Ob-Gyn Dep., Western Galilee MC Not yet recruiting
Nahariya, Israel, 65742
Contact: Menahem Neuman, Prof.    +972-546-444-033    mneuman@netvision.net.il   
Western Galilee MC Recruiting
Nahariya, Israel, 22110
Contact: Menahem Neuman, Prof    +972-546-444-033    mneuman@netvision.net.il   
Principal Investigator: Menahem Neuman, Prof         
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Investigators
Principal Investigator: Menahem Neuman, Prof. Faculty of Medicine, Bar-Ilan Univ., Zafed
  More Information

No publications provided

Responsible Party: menahem neuman, Primary Investigator, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT01739374     History of Changes
Other Study ID Numbers: HTA5969, 24411
Study First Received: November 22, 2012
Last Updated: July 2, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014