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Completed

NCT Number: NCT01348334

Synthetic Mesh Materials In Sling Surgery

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.

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Key information

Conditions

Incontinence

Age range

31 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. continence rates at three years after surgery

    Time frame: 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.

Secondary outcomes

  1. urethral erosion at three years after surgery

    Time frame: three years after surgery

  2. vaginal erosion at three years after surgery

    Time frame: three years after surgery

  3. Denovo urgency at three years after surgery

    Time frame: three years after surgery

  4. urine retantion at three years after surgery

    Time frame: three years after surgery

  5. sutur granuloma at three years after surgery

    Time frame: three years after surgery

Sponsors and collaborators

Lead sponsor

Ataturk Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2010
First posted
May 5, 2011
Registry last updated
May 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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