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Comparison Between Two Types of Meshes Used in Pelvic Organs Prolapse Procedures

Comparison Between Two Types of Meshes Used in Pelvic Organs Prolapse Procedures

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01645020
Enrollment
240
Registered
2012-07-19
Start date
2008-08-31
Completion date
2013-06-30
Last updated
2012-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Keywords

absorbable mesh, Partially absorbed Mesh, Prolift, Prolift + M, mesh related complications

Brief summary

Using partially absorbed meshes in pelvic reconstructive surgery will involve fewer postoperative complications especially less pain caused by the mesh mass.

Detailed description

Weakness of pelvic floor support is the cause defects and damage to pelvic organs functioning and urinary control and it has a pretty common occurrence. It was suggested recently that the event is considered a hernia that requires mesh use, which reduces return rates following pelvic floor repair. Mesh use is known to cause complications and unwanted side effects, such as chronic pain, vaginal network exposure and infection. The degree of complications is related directly to the mass of the mesh, and that's why the absorbable meshes were developed.Two months after the surgery with absorbable mesh, the mass left in the patient's body is half of the initial mesh mass and according to our assumption this effect will minimize the extent and intensity of mesh complications compared with conventional ones. During the study we will examine medical records of women who have had surgery with pelvic floor reconstructive meshes. The cases will be divided according to the mesh type being used. A polypropylene mesh (single strand and tunneling wide) trade name Prolift, and similar mesh that contains approximately half of the network mass after being dissolves in two months, a trade name Prolift + M. The number of participants in each group is 120 women. The post-operative follow-up examination will include three points in time. After a month, six months and a year later. In addition to questionnaires in order to quantify the degree of urinary disturbance, pain after surgery and sexual function.

Interventions

None listed

Sponsors

Western Galilee Hospital-Nahariya
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Women who had pelvic floor repair surgery wit mesh used to the posterior vaginal wall.

Exclusion criteria

* Women with significant pre-operative pain * Women with collagen diseases * Women who underwent pelvic floor repair surgery with mesh to the anterior vaginal wall

Countries

Israel

Contacts

Primary ContactM Neuman, MD
mneuman@netvision.net.il972 3 956 3105
Backup ContactR sawaid, MD
raneen.sawaid@gmail.com972 4 956 3035

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026