Synthetic Mesh Materials In Sling Surgery

Incontinence Clinical Trial

Official title:

Use Of Three Types Of Synthetic Mesh Materials In Sling Surgery: A Prospective Randomized Clinical Trial Evaluating Effectiveness And Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348334
• Other study ID #: Ataturk TRH-01
• Status: Completed
• Phase: N/A
• First received: April 28, 2011
• Last updated: May 4, 2011
• Start date: July 2004
• Est. completion date: November 2010

Study information

• Verified date: July 2004
• Source: Ataturk Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the clinical results contributions to surgical success,and complications of mixed type of mesh materials as well as prolen mesh materials in sling surgery in a 3 year follow-up the first time in literature.

Description:

Broad based double forced sling operations were performed in 144 patients by using 3 different types of mesh materials between 2004 and 2007. Group I consisted of 48 patients in whom Vypromesh® (Ethicon,USA) was used; Group II consisted of 48 patients in whom Ultrapromesh®( Ethicon,USA) and Group III consisted of 48 patients in whom Prolene light mesh® (Johnson&Johnson,USA) was used. The data of the patients and the success of the operation were evaluated based on 24hr pad test, ICIQ-SF scoring, and Korman questionnaire analysis.

Main outcome measures:The Ultrapromesh® synthetic sling procedures have lower complications incidence and higher success rates than the other synthetic slings in 3-year follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: November 2010
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 31 Years to 75 Years

Eligibility

Inclusion Criteria:

• Stress urinary incontinence

• Mix urinary incontinence

• Previous failed anti-incontinence surgery

• Previous gynecologic surgery

Exclusion Criteria:

• Urodynamical detrusor overactivity or impaired bladder activity

• Prolaps of pelvic organ

• Urge incontinence

• Neurogenic bladder

• Bladder outlet obstruction

• Urinary fistula, Pregnancy

• Active urinary or vaginal enfection

• Contraindication to anesthesia

• > 100ml PVR urine volume

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Incontinence

Intervention

Procedure:
• Synthetic sling surgery
An incision of inverted A shape was inflicted on the anterior vaginal wall(AVW)of the vagina.The upper part of A shaped incision was formed into an island belonging to the vaginal wall.This patch was 3×4cm in most of the patients.Proximal AVWwas dissected as a flap.Synthetics mesh materials were first sutured onto the upper part of the A on the vaginal island with absorbable vicrly sutures.Then,with 2polypropilen sutures,these meshes were fixed on both the right and left sides of this island in a helical manner to form a suspension and using curved Kishner needles,the prolene sutures were transferred to suprapubic area.These sutures were ligated on the rectus fascia in a crosswise manner.The mobile lower wing was advanced onto the island and was sutured onto the vaginal skin with intermittent sutures using 3-0 monocryl sutures.After cystoscopy,the prolene sutures were ligated crosswise in the suprapubic region.Special attention was paid notto create much tension on the mesh material.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	continence rates at three years after surgery	Ultrapromesh® with its superior biomechanical characteristics and with its high success rates,low vaginal and urethral extrusion and denovo urgency rates determined in clinical studies,can be reliably and effectively used in sling surgery.	three years after surgery	No
Secondary	urethral erosion at three years after surgery		three years after surgery	No
Secondary	vaginal erosion at three years after surgery		three years after surgery	No
Secondary	Denovo urgency at three years after surgery		three years after surgery	No
Secondary	urine retantion at three years after surgery		three years after surgery	No
Secondary	sutur granuloma at three years after surgery		three years after surgery	No