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Efficacy and Safety of Reduced Pelvic Floor Mesh Implants

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ClinicalTrials.gov Identifier: NCT01739374
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : June 18, 2015
Sponsor:
Information provided by (Responsible Party):

November 22, 2012
December 3, 2012
June 18, 2015
May 2013
May 2014   (Final data collection date for primary outcome measure)
Intra-operative and post operative adverse effects [ Time Frame: One year post operative ]
Vaginal and pelvic pain upon VAS, vaginal mesh exposure, infections.
Same as current
Complete list of historical versions of study NCT01739374 on ClinicalTrials.gov Archive Site
Efficacy [ Time Frame: One year ]
Pelvic organ prolapse reconstruction upon the International Continence Society Pelvic Organ Prolapse Quantification System measurements
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Reduced Pelvic Floor Mesh Implants
Phase 2-3 Study of Efficacy and Safety of Reduced Pelvic Floor Mesh Implants
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.

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.

Interventional
Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Post Operative Pain
  • Complication of Surgical Procedure
Other: reduced mesh implants
mesh for pelvic floor reinforcement
Experimental: Device - Reduced mesh implants
Patients treated with reduced mesh implants for POP reconstruction
Intervention: Other: reduced mesh implants
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2015
May 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

-Patients with advanced pelvic organ prolapse

Exclusion Criteria:

- Patients with active infections or after pelvic irradiation

Sexes Eligible for Study: Female
35 Years to 95 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01739374
HTA5969
24411 ( Other Identifier: Local IRB )
No
Not Provided
Not Provided
menahem neuman, Western Galilee Hospital-Nahariya
Western Galilee Hospital-Nahariya
Not Provided
Principal Investigator: Menahem Neuman, Prof. Faculty of Medicine, Bar-Ilan Univ., Zafed
Western Galilee Hospital-Nahariya
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP