A Randomized Controlled Study Comparing Three Single-incision Devices for Female Urinary Stress Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): MiniArc positioning; TVT secur system positioning; Ajust positioning; Tension free vaginal ttape
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): 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.; 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: single-incision; sling; stress incontinence; surgery; treatment; Female urinary stress incontinence