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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01645020
• Other study ID #: 20
• Status: Recruiting
• Phase: N/A
• First received: July 17, 2012
• Last updated: July 18, 2012
• Start date: August 2008
• Est. completion date: June 2013

Study information

• Verified date: July 2012
• Source: Western Galilee Hospital-Nahariya
• Contact: M Neuman, MD
• Phone: 972 3 956 3105
• Email: mneuman[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Postoperative Complications

Locations

Country	Name	City	State
Israel	Western Galilee Hospital	Nahariya

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Khandwala S, Jayachandran C. Transvaginal mesh surgery for pelvic organ prolapse--Prolift+M: a prospective clinical trial. Int Urogynecol J. 2011 Nov;22(11):1405-11. doi: 10.1007/s00192-011-1482-4. Epub 2011 Jul 1. — View Citation

External Links

•   GYNECARE PROLIFT+M™ was developed by Ethicon Women's Health & Urologyoffers. this company offers treatment solutions for a range of female pelvic health disorders.