Urinary IncontinencePhase 4NCT00751088
A Randomized Controlled Study Comparing Three Single-incision Devices for Female Urinary Stress Incontinence
A Phase 4 study testing MiniArc positioning, TVT secur system positioning and Ajust positioning in people with Urinary Incontinence, run by University Magna Graecia at 1 site in Italy.
Trial summary
The prevalence of urinary stress incontinence in middle age women is rated at about 30%. To date, there is an increasing use in the clinical practice of new techniques for the treatment of this condition and several surgical devices, characterized by minimally invasive approach, are commercialized. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- MiniArc positioning, TVT secur system positioning and Ajust positioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Sep 2008to not given
- Phase
- Phase 4
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- genuine stress incontinence
Who cannot join
- pregnancy
- <12 months postpartum
- systemic disease and/or drugs known to affect bladder function
- current chemotherapy or radiation therapy
- urethral diverticulum
- augmentation cytoplasty
Show all 12Show fewer
- artificial sphincter
- genital prolapse equal to or more than second degree
- history of severe abdominopelvic infections
- detrusor instability and/or intrinsic sphincter dysfunction
- other gynecologic pathologies
- BMI >30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Among Three Single-incision Devices for the Treatment of Female Urinary Genuine Stress Incontinence: a Randomized Controlled Study.
The prevalence of urinary stress incontinence in middle age women is rated at about 30%. To date, there is an increasing use in the clinical practice of new techniques for the treatment of this condition and several surgical devices, characterized by minimally invasive approach, are commercialized.
Recently, single-incision devices have been proposed. One of the most relevant potential advantages of these devices is the possibility of performing their positioning under local anesthesia, thus, in ambulatory regimen. The employment of these devices is particularly useful in two subgroups of patients with urinary incontinence, i.e. women with genuine stress incontinence not associated to pelvic organ prolapse (POP) and women whose stress incontinence raised after surgical correction of (severe) POP.
Poor data coming from randomized controlled trials (RCTs) are available regarding single-incision devices for the treatment of stress incontinence, and there are no conclusions in terms of their feasibility, efficacy and safety. Finally, to our knowledge no randomized controlled trial is actually available in literature comparing different single-incision devices.
Read the detailed description
Women with genuine urinary stress incontinence not associated with POP will be enrolled and randomized in three groups (arm 1, arm 2 and arm 3). All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, ultrasonographic and urodynamic evaluations. At time of surgery, all patients will be randomized in three surgical treatment groups (arm 1, 2 and 3). Patients of arm 1 will be treated with positioning of Ajust (Bard Urological Division, Covington, GA, USA), patients of group 2 will be treated with positioning of MiniArc (AMS, Minnetonka, MN, USA) and patients of arm 3 will be treated with positioning of TVT Secur System (Ethicon, Somerville, NJ, USA).
During the study, the clinical outcomes, and the adverse experience will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.
- Conditions
- Urinary Incontinence
- Being tested
- MiniArc positioning, TVT secur system positioning, Ajust positioning, Tension free vaginal ttape
- Keywords
- single-incision, sling, stress incontinence, surgery, treatment, Female urinary stress incontinence
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiniArc positioningProcedure or surgery
Patient placed in lithotomic position. 1.5 cm incision made, starting 1 cm down to the urethral meatus. Tunneling wide to 12-15 mm up to the bonny edge horizontally to the inferior pubic arm by spreading the scissors blades while withdrawing it, at a plane parallel to the vaginal wall. Mucosal undermining performed at the level of the upper and lower "frenulum" attaching the sub-urethral tissue to the vaginal wall. Insertion of the device to the bonny edge, horizontaly to the inferior pubic arm, and behind the bone edge to the internal obturator muscle. MiniArc will be placed by means of curved single use needle. Incision closure.
TVT secur system positioningProcedure or surgery
Patient placed in lithotomic position. 1.5 cm incision made, starting 1 cm down to the urethral meatus. Tunneling wide to 12-15 mm up to the bonny edge horizontally to the inferior pubic arm by spreading the scissors blades while withdrawing it, at a plane parallel to the vaginal wall. Mucosal undermining performed at the level of the upper and lower "frenulum" attaching the sub-urethral tissue to the vaginal wall. Insertion of the device to the bonny edge, horizontaly to the inferior pubic arm, and behind the bone edge to the internal obturator muscle. TVT Secur System will be placed by means of two curved, stainless steel, single use introducers. Incision closure.
Ajust positioningProcedure or surgery
Patient placed in lithotomic position. 1.5 cm incision made, starting 1 cm down to the urethral meatus. Tunneling wide to 12-15 mm up to the bonny edge horizontally to the inferior pubic arm by spreading the scissors blades while withdrawing it, at a plane parallel to the vaginal wall. Mucosal undermining performed at the level of the upper and lower "frenulum" attaching the sub-urethral tissue to the vaginal wall. Insertion of the device to the bonny edge, horizontaly to the inferior pubic arm, and behind the bone edge to the internal obturator muscle. Ajust will be placed by means of a safe hook geometry introducer. Incision closure.
Tension free vaginal ttapeProcedure or surgery
Patient placed in lithotomic position. 15 mm vaginal incision below urethral meatus. Dissection of the paraurethral space on each side of the incision and of the bladder from the inferior edge of the pubis. Transversal 10 mm skin incisions at level of superior pubic margin. Top-down or bottom-up approach passage of the needles and sling. Adjustment of sling tension. Closure of vaginal and skin incisions.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients treated with Ajust positioning Receives: Procedure: Ajust positioning |
| 2 | Active comparator | Patients treated with MiniArc positioning Receives: Procedure: MiniArc positioning |
| 3 | Active comparator | Patients treated with TVT secur system Receives: Procedure: TVT secur system positioning |
| 4 | Active comparator | Patients treated with tension free vaginal tape Receives: Procedure: Tension free vaginal ttape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective cure rate (compared to results of TVT)
Secondary outcomes (12)
Objective cure rate
Intraoperative complication rate
Measured: one day
Blood loss
Postoperative complication rate
Measured: thirty days
Long-term complication rate
Measured: twelve months
Postoperative pain
Patients' satisfaction
Sexual function
Quality of life
Recurrence rate
Feasibility (degree of surgical difficulty in non-trained surgeons)
Learning curve (change in operative time, intra- and post-operative complications over the time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study startSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Investigators
- Stefano Palomba, MD, Principal investigator, Chair of Obstetrics and Gynecology, University "Magna Graecia" of CatanzaroFulvio Zullo, MD, Study chair, Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751088
- Sponsor's protocol ID
- 04/2008
- Status last verified
- Jul 2009
- First submitted
- 10 Sep 2008
- Last updated
- 27 Feb 2013
- Results posted
- 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 37888839Palomba S, Falbo A, Oppedisano R, Torella M, Materazzo C, Maiorana A, Tolino A, Mastrantonio P, La Sala GB, Alio L, Colacurci N, Zullo F; SIMS Italian Group. A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence. Int Urogynecol J. 2014 Oct;25(10):1333-41. doi: 10.1007/s00192-014-2383-0. Epub 2014 Apr 16.
PubMed 24737301Palomba S, Oppedisano R, Falbo A, Torella M, Maiorana A, Materazzo C, Tolino A, Mastrantonio P, La Sala GB, Alio L, Colacurci N, Zullo F; SIMS Italian Group. Single-incision mini-slings versus retropubic tension-free vaginal tapes: a multicenter clinical trial. J Minim Invasive Gynecol. 2014 Mar-Apr;21(2):303-10. doi: 10.1016/j.jmig.2013.08.714. Epub 2013 Oct 19.
PubMed 24148568Palomba S, Oppedisano R, Torella M, Falbo A, Maiorana A, Materazzo C, Tartaglia E, Tolino A, Mastrantonio P, Alio L, Colacurci N, Zullo F; SIMS Italian Group. A randomized controlled trial comparing three vaginal kits of single-incision mini-slings for stress urinary incontinence: surgical data. Eur J Obstet Gynecol Reprod Biol. 2012 Jul;163(1):108-12. doi: 10.1016/j.ejogrb.2012.03.038. Epub 2012 May 1.
PubMed 22552180
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Among Three Single-incision Devices for the Treatment of Female Urinary Genuine Stress Incontinence: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT00751088
- Acronym / sponsor ID
- 04/2008
- Conditions
- Urinary Incontinence
- Keywords
- single-incision, sling, stress incontinence, surgery, treatment, Female urinary stress incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- Sep 2008
- First posted
- 11 Sep 2008 (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 prevalence of urinary stress incontinence in middle age women is rated at about 30%. To date, there is an increasing use in the clinical practice of new techniques for the treatment of this condition and several surgical devices, characterized by minimally invasive approach, are commercialized.
Recently, single-incision devices have been proposed. One of the most relevant potential advantages of these devices is the possibility of performing their positioning under local anesthesia, thus, in ambulatory regimen. The employment of these devices is particularly useful in two subgroups of patients with urinary incontinence, i.e. women with genuine stress incontinence not associated to pelvic organ prolapse (POP) and women whose stress incontinence raised after surgical correction of (severe) POP.
Poor data coming from randomized controlled trials (RCTs) are available regarding single-incision devices for the treatment of stress incontinence, and there are no conclusions in terms of their feasibility, efficacy and safety. Finally, to our knowledge no randomized controlled trial is actually available in literature comparing different single-incision devices.
Detailed description
Women with genuine urinary stress incontinence not associated with POP will be enrolled and randomized in three groups (arm 1, arm 2 and arm 3). All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, ultrasonographic and urodynamic evaluations. At time of surgery, all patients will be randomized in three surgical treatment groups (arm 1, 2 and 3). Patients of arm 1 will be treated with positioning of Ajust (Bard Urological Division, Covington, GA, USA), patients of group 2 will be treated with positioning of MiniArc (AMS, Minnetonka, MN, USA) and patients of arm 3 will be treated with positioning of TVT Secur System (Ethicon, Somerville, NJ, USA).
During the study, the clinical outcomes, and the adverse experience will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Ajust positioningPatients treated with Ajust positioning |
| 2 | Active comparator | Procedure: MiniArc positioningPatients treated with MiniArc positioning |
| 3 | Active comparator | Procedure: TVT secur system positioningPatients treated with TVT secur system |
| 4 | Active comparator | Procedure: Tension free vaginal ttapePatients treated with tension free vaginal tape |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- genuine stress incontinence
Key exclusion criteria (12 listed)
- pregnancy
- <12 months postpartum
- systemic disease and/or drugs known to affect bladder function
- current chemotherapy or radiation therapy
- urethral diverticulum
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 |
|---|---|---|
| MiniArc positioningPatient placed in lithotomic position. 1.5 cm incision made, starting 1 cm down to the urethral meatus. Tunneling wide to 12-15 mm up to the bonny edge horizontally to the inferior pubic arm by spreading the scissors blades while withdrawing it, at a plane parallel to the vaginal wall. Mucosal undermining performed at the level of the upper and lower "frenulum" attaching the sub-urethral tissue to the vaginal wall. Insertion of the device to the bonny edge, horizontaly to the inferior pubic arm, and behind the bone edge to the internal obturator muscle. MiniArc will be placed by means of curved single use needle. Incision closure. | Procedure or surgery | 2 |
| TVT secur system positioningPatient placed in lithotomic position. 1.5 cm incision made, starting 1 cm down to the urethral meatus. Tunneling wide to 12-15 mm up to the bonny edge horizontally to the inferior pubic arm by spreading the scissors blades while withdrawing it, at a plane parallel to the vaginal wall. Mucosal undermining performed at the level of the upper and lower "frenulum" attaching the sub-urethral tissue to the vaginal wall. Insertion of the device to the bonny edge, horizontaly to the inferior pubic arm, and behind the bone edge to the internal obturator muscle. TVT Secur System will be placed by means of two curved, stainless steel, single use introducers. Incision closure. | Procedure or surgery | 3 |
| Ajust positioningPatient placed in lithotomic position. 1.5 cm incision made, starting 1 cm down to the urethral meatus. Tunneling wide to 12-15 mm up to the bonny edge horizontally to the inferior pubic arm by spreading the scissors blades while withdrawing it, at a plane parallel to the vaginal wall. Mucosal undermining performed at the level of the upper and lower "frenulum" attaching the sub-urethral tissue to the vaginal wall. Insertion of the device to the bonny edge, horizontaly to the inferior pubic arm, and behind the bone edge to the internal obturator muscle. Ajust will be placed by means of a safe hook geometry introducer. Incision closure. | Procedure or surgery | 1 |
| Tension free vaginal ttapePatient placed in lithotomic position. 15 mm vaginal incision below urethral meatus. Dissection of the paraurethral space on each side of the incision and of the bladder from the inferior edge of the pubis. Transversal 10 mm skin incisions at level of superior pubic margin. Top-down or bottom-up approach passage of the needles and sling. Adjustment of sling tension. Closure of vaginal and skin incisions. | Procedure or surgery | 4 |
Primary outcome
Subjective cure rate (compared to results of TVT)
12 secondary outcomes
Objective cure rate
Intraoperative complication rate
Time frame: one day
Blood loss
Postoperative complication rate
Time frame: thirty days
Long-term complication rate
Time frame: twelve months
Postoperative pain
Patients' satisfaction
Sexual function
Quality of life
Recurrence rate
Feasibility (degree of surgical difficulty in non-trained surgeons)
Learning curve (change in operative time, intra- and post-operative complications over the time
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 27 Feb 2013.
- 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.
- Derived from this study: PubMed 24737301Palomba S, Falbo A, Oppedisano R, Torella M, Materazzo C, Maiorana A, Tolino A, Mastrantonio P, La Sala GB, Alio L, Colacurci N, Zullo F; SIMS Italian Group. A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence. Int Urogynecol J. 2014 Oct;25(10):1333-41. doi: 10.1007/s00192-014-2383-0. Epub 2014 Apr 16.
- Derived from this study: PubMed 24148568Palomba S, Oppedisano R, Falbo A, Torella M, Maiorana A, Materazzo C, Tolino A, Mastrantonio P, La Sala GB, Alio L, Colacurci N, Zullo F; SIMS Italian Group. Single-incision mini-slings versus retropubic tension-free vaginal tapes: a multicenter clinical trial. J Minim Invasive Gynecol. 2014 Mar-Apr;21(2):303-10. doi: 10.1016/j.jmig.2013.08.714. Epub 2013 Oct 19.
- Derived from this study: PubMed 22552180Palomba S, Oppedisano R, Torella M, Falbo A, Maiorana A, Materazzo C, Tartaglia E, Tolino A, Mastrantonio P, Alio L, Colacurci N, Zullo F; SIMS Italian Group. A randomized controlled trial comparing three vaginal kits of single-incision mini-slings for stress urinary incontinence: surgical data. Eur J Obstet Gynecol Reprod Biol. 2012 Jul;163(1):108-12. doi: 10.1016/j.ejogrb.2012.03.038. Epub 2012 May 1.
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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.
Stefano Palomba, MD principal investigator
Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Fulvio Zullo, MD study chair
Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MiniArc positioning, TVT secur system positioning and Ajust positioning in people with Urinary Incontinence, run by University Magna Graecia at 1 site in Italy.
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 1 inclusion and 12 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 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Subjective cure rate (compared to results of TVT). 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 NCT00751088, which also lists 4 linked publications.
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 27 Feb 2013.