IncontinenceNCT01348334
Synthetic Mesh Materials In Sling Surgery
A study testing Synthetic sling surgery in people with Incontinence, run by Ataturk Training and Research Hospital.
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. Read more about this study
- Who is it for?
- Ages 31 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Incontinence
- What is being tested?
- Synthetic sling surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stress urinary incontinence
- Mix urinary incontinence
- Previous failed anti-incontinence surgery
- Previous gynecologic surgery
Who cannot join
- Urodynamical detrusor overactivity or impaired bladder activity
- Prolaps of pelvic organ
- Urge incontinence
- Neurogenic bladder
- Bladder outlet obstruction
- Urinary fistula, Pregnancy
Show all 9Show fewer
- Active urinary or vaginal enfection
- Contraindication to anesthesia
- > 100ml PVR urine volume
About this study
Official title: Use Of Three Types Of Synthetic Mesh Materials In Sling Surgery: A Prospective Randomized Clinical Trial Evaluating Effectiveness And Complications
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.
Read the 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.
- Conditions
- Incontinence
- Being tested
- Synthetic sling surgery
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synthetic sling surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Vypromesh®(Ethicon,USA) | Active comparator | Vypromesh®(semiabsorbable multiflament mesh;non-absorbable Polypropylene+absorbable Poliglactin) Receives: Procedure: Synthetic sling surgery |
| Ultrapromesh®(Ethicon,USA) | Active comparator | Ultrapromesh®(semiabsorbable monofilament mesh;non-absorbable Polypropylene+absorbable polyglecaprone). Receives: Procedure: Synthetic sling surgery |
| Prolene light mesh®(Johnson&Johnson,USA) | Active comparator | Prolene light mesh®(cpp-Condensed monofilament non absorbable polypropylene mesh) Receives: Procedure: Synthetic sling surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three years after surgery
Secondary outcomes (5)
urethral erosion at three years after surgery
Measured: three years after surgery
vaginal erosion at three years after surgery
Measured: three years after surgery
Denovo urgency at three years after surgery
Measured: three years after surgery
urine retantion at three years after surgery
Measured: three years after surgery
sutur granuloma at three years after surgery
Measured: three years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startJul 2004
- Primary completionJul 2007
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348334
- Sponsor's protocol ID
- Ataturk TRH-01
- Status last verified
- Jul 2004
- First submitted
- 28 Apr 2011
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37888839
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Of Three Types Of Synthetic Mesh Materials In Sling Surgery: A Prospective Randomized Clinical Trial Evaluating Effectiveness And Complications
- ClinicalTrials.gov ID
- NCT01348334
- Acronym / sponsor ID
- Ataturk TRH-01
- 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.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vypromesh®(Ethicon,USA) | Active comparator | Procedure: Synthetic sling surgeryVypromesh®(semiabsorbable multiflament mesh;non-absorbable Polypropylene+absorbable Poliglactin) |
| Ultrapromesh®(Ethicon,USA) | Active comparator | Procedure: Synthetic sling surgeryUltrapromesh®(semiabsorbable monofilament mesh;non-absorbable Polypropylene+absorbable polyglecaprone). |
| Prolene light mesh®(Johnson&Johnson,USA) | Active comparator | Procedure: Synthetic sling surgeryProlene light mesh®(cpp-Condensed monofilament non absorbable polypropylene mesh) |
Who may qualify
- Ages
- 31 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stress urinary incontinence
- Mix urinary incontinence
- Previous failed anti-incontinence surgery
- Previous gynecologic surgery
Key exclusion criteria (9 listed)
- Urodynamical detrusor overactivity or impaired bladder activity
- Prolaps of pelvic organ
- Urge incontinence
- Neurogenic bladder
- Bladder outlet obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synthetic sling surgeryAn 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. | Procedure or surgery | Prolene light mesh®(Johnson&Johnson,USA), Ultrapromesh®(Ethicon,USA), Vypromesh®(Ethicon,USA) |
Primary outcome
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.
5 secondary outcomes
urethral erosion at three years after surgery
Time frame: three years after surgery
vaginal erosion at three years after surgery
Time frame: three years after surgery
Denovo urgency at three years after surgery
Time frame: three years after surgery
urine retantion at three years after surgery
Time frame: three years after surgery
sutur granuloma at three years after surgery
Time frame: three years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2011.
- Derived from this study: PubMed 37888839Carter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Synthetic sling surgery in people with Incontinence, run by Ataturk Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
continence rates at three years after surgery (time frame: three years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01348334, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2011.