CClinicalTrials.gg
CompletedNCT01739374Updated Jun 18, 2015

Efficacy and Safety of Reduced Pelvic Floor Mesh Implants

A Phase 2/3 interventional study of reduced mesh implants in Post Operative Pain and Complication of Surgical Procedure, sponsored by Western Galilee Hospital-Nahariya. Completed at 2 sites in Israel. Open to female participants aged 35 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-18.

Sponsored by Western Galilee Hospital-Nahariya · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
35 Years to 95 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Post Operative Pain
  • Complication of Surgical Procedure

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Keywords

  • pelvic floor reconstruction
  • mesh implants
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 100 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Western Galilee Hospital-Nahariya is the lead sponsor of 87 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 95 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

-Patients with advanced pelvic organ prolapse

Exclusion criteria

Exclusion Criteria:

  • Patients with active infections or after pelvic irradiation
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Device - Reduced mesh implants

    Patients treated with reduced mesh implants for POP reconstruction

    Other: reduced mesh implants

Interventions

  • Otherreduced mesh implants

    mesh for pelvic floor reinforcement

06

What researchers measure

Primary outcomes

  1. Intra-operative and post operative adverse effects

    Vaginal and pelvic pain upon VAS, vaginal mesh exposure, infections.

    Time frame: One year post operative

Secondary outcomes

  1. Efficacy

    Pelvic organ prolapse reconstruction upon the International Continence Society Pelvic Organ Prolapse Quantification System measurements

    Time frame: One year

07

Study locations

2 sites
  • Western Galilee MC
    Nahariya, 22110, Israel
  • Ob-Gyn Dep., Western Galilee MC
    Nahariya, 65742, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01739374
Lead sponsor
Western Galilee Hospital-Nahariya
Responsible party
menahem neuman (Primary Investigator, Western Galilee Hospital-Nahariya) — Principal investigator
First posted
Dec 3, 2012
Start date
May 2013
Primary completion
May 2014
Completion
Mar 2015
Last update
Jun 18, 2015

Study contacts

Menahem Neuman, Prof.
principal investigator · Faculty of Medicine, Bar-Ilan Univ., Zafed

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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