Synthetic Mesh Materials In Sling Surgery

NCT01348334 | Completed

• 1 other identifier: Ataturk TRH-01
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Incontinence

Keywords

Sling surgery; synthetic meshes; ultrapromesh®; mix mesh; incontinence; The Ultrapromesh® synthetic sling procedures have lower complications incidence and higher success rates than the other synthetic slings in 3-year follow-up.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• urethral erosion at three years after surgery

  three years after surgery

• vaginal erosion at three years after surgery

  three years after surgery

• Denovo urgency at three years after surgery

  three years after surgery

• urine retantion at three years after surgery

  three years after surgery

• sutur granuloma at three years after surgery

  three years after surgery

Study Arms (3)

Vypromesh®(Ethicon,USA)

ACTIVE COMPARATOR

Vypromesh®(semiabsorbable multiflament mesh;non-absorbable Polypropylene+absorbable Poliglactin)

Procedure: Synthetic sling surgery

Ultrapromesh®(Ethicon,USA)

ACTIVE COMPARATOR

Ultrapromesh®(semiabsorbable monofilament mesh;non-absorbable Polypropylene+absorbable polyglecaprone).

Procedure: Synthetic sling surgery

Prolene light mesh®(Johnson&Johnson,USA)

ACTIVE COMPARATOR

Prolene light mesh®(cpp-Condensed monofilament non absorbable polypropylene mesh)

Procedure: Synthetic sling surgery

Interventions

Synthetic sling surgery PROCEDURE

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.

Prolene light mesh®(Johnson&Johnson,USA); Ultrapromesh®(Ethicon,USA); Vypromesh®(Ethicon,USA)

Eligibility Criteria

• Age: 31 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stress urinary incontinence
• Mix urinary incontinence
• Previous failed anti-incontinence surgery
• Previous gynecologic surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk Training and Research Hospital: lead

Related Publications (1)

• Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.

  PMID: 37888839 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: May 5, 2011
• Study Start: July 1, 2004
• Primary Completion: July 1, 2007
• Study Completion: November 1, 2010
• Last Updated: May 5, 2011

Record last verified: 2004-07