A Randomized Controlled Study Comparing Three Single-incision Devices for Female Urinary Stress Incontinence

NCT00751088 | Completed Phase 4

• 1 other identifier: 04/2008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Urinary Incontinence

Keywords

single-incision; sling; stress incontinence; surgery; treatment; Female urinary stress incontinence

Outcome Measures

Primary Outcomes (1)

• Subjective cure rate (compared to results of TVT)

Secondary Outcomes (12)

• Objective cure rate

• Intraoperative complication rate

  one day

• Blood loss

• Postoperative complication rate

  thirty days

• Long-term complication rate

  twelve months

Study Arms (4)

1

ACTIVE COMPARATOR

Patients treated with Ajust positioning

Procedure: Ajust positioning

2

ACTIVE COMPARATOR

Patients treated with MiniArc positioning

Procedure: MiniArc positioning

3

ACTIVE COMPARATOR

Patients treated with TVT secur system

Procedure: TVT secur system positioning

4

ACTIVE COMPARATOR

Patients treated with tension free vaginal tape

Procedure: Tension free vaginal ttape

Interventions

MiniArc positioning PROCEDURE

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.

2

TVT secur system positioning PROCEDURE

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.

3

Ajust positioning PROCEDURE

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.

1

Tension free vaginal ttape PROCEDURE

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.

4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• genuine stress incontinence

You may not qualify if:

• pregnancy
• \<12 months postpartum
• systemic disease and/or drugs known to affect bladder function
• current chemotherapy or radiation therapy
• urethral diverticulum
• augmentation cytoplasty
• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

"Pugliese" Hospital

Catanzaro, Catanzaro, 88100, Italy

Location

Related Publications (4)

• 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.

  PMID: 37888839 DERIVED

• Palomba 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.

  PMID: 24737301 DERIVED

• Palomba 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.

  PMID: 24148568 DERIVED

• Palomba 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.

  PMID: 22552180 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefano Palomba, MD

  Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

  PRINCIPAL INVESTIGATOR

• Fulvio Zullo, MD

  Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 10, 2008
• First Posted: September 11, 2008
• Study Start: September 1, 2008
• Last Updated: February 27, 2013

Record last verified: 2009-07

Locations

IT (1)