Synthetic Mesh Materials In Sling Surgery

This study has been completed.
Sponsor:
Information provided by:
Ataturk Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01348334
First received: April 28, 2011
Last updated: May 4, 2011
Last verified: July 2004
  Purpose

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.


Condition Intervention
Incontinence
Procedure: Synthetic sling surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Use Of Three Types Of Synthetic Mesh Materials In Sling Surgery: A Prospective Randomized Clinical Trial Evaluating Effectiveness And Complications

Further study details as provided by Ataturk Training and Research Hospital:

Primary Outcome Measures:
  • continence rates at three years after surgery [ Time Frame: three years after surgery ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • urethral erosion at three years after surgery [ Time Frame: three years after surgery ] [ Designated as safety issue: No ]
  • vaginal erosion at three years after surgery [ Time Frame: three years after surgery ] [ Designated as safety issue: No ]
  • Denovo urgency at three years after surgery [ Time Frame: three years after surgery ] [ Designated as safety issue: No ]
  • urine retantion at three years after surgery [ Time Frame: three years after surgery ] [ Designated as safety issue: No ]
  • sutur granuloma at three years after surgery [ Time Frame: three years after surgery ] [ Designated as safety issue: No ]

Enrollment: 144
Study Start Date: July 2004
Study Completion Date: November 2010
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vypromesh®(Ethicon,USA)
Vypromesh®(semiabsorbable multiflament mesh;non-absorbable Polypropylene+absorbable Poliglactin)
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.
Active Comparator: Ultrapromesh®(Ethicon,USA)
Ultrapromesh®(semiabsorbable monofilament mesh;non-absorbable Polypropylene+absorbable polyglecaprone).
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.
Active Comparator: Prolene light mesh®(Johnson&Johnson,USA)
Prolene light mesh®(cpp-Condensed monofilament non absorbable polypropylene mesh)
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   31 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Emrah Okulu, Ataturk Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01348334     History of Changes
Other Study ID Numbers: Ataturk TRH-01
Study First Received: April 28, 2011
Last Updated: May 4, 2011
Health Authority: Turkey: Ministry of Health

Keywords provided by Ataturk Training and Research Hospital:
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.

ClinicalTrials.gov processed this record on September 18, 2014