Synthetic Mesh Materials In Sling Surgery

Sponsor

Ataturk Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01348334

Collaborator

(none)

144

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Incontinence	Procedure: Synthetic sling surgery	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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

Study Start Date :

Jul 1, 2004

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

Active Comparator: Prolene light mesh®(Johnson&Johnson,USA)

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

Procedure: Synthetic sling surgery

Outcome Measures

Primary Outcome Measures

continence rates at three years after surgery [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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

31 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

No locations specified.

Sponsors and Collaborators

Ataturk Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01348334

Other Study ID Numbers:

Ataturk TRH-01

First Posted:

May 5, 2011

Last Update Posted:

May 5, 2011

Last Verified:

Jul 1, 2004

Keywords provided by , ,

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

Study Results

No Results Posted as of May 5, 2011