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 anaesthesia, 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 study is actually available in literature comparing two different single-incision devices.
Primary Outcome Measures:
- Feasibility (degree of surgical difficulty in non-trained surgeons) [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Learning curve [ Designated as safety issue: No ]
- Intra-operative complication rate [ Time Frame: one day ] [ Designated as safety issue: Yes ]
- Blood loss [ Designated as safety issue: Yes ]
- Postoperative complication rate [ Time Frame: thirty days ] [ Designated as safety issue: Yes ]
- Long-term complication rate [ Time Frame: twelve months ] [ Designated as safety issue: Yes ]
- Postoperative pain [ Designated as safety issue: Yes ]
- Patients' satisfaction [ Designated as safety issue: No ]
- Sexual function [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Failure rate [ Designated as safety issue: No ]
- Recurrence rate [ Designated as safety issue: No ]
- de novo urge incontinence rate [ Designated as safety issue: No ]
| Study Start Date: |
September 2008 |
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1: Active Comparator
Patients treated with MiniArc positioning
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Procedure: MiniArc positioning
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. Fine tuning of the tape tension by means of cough test prior to remove the inserter. Incision closure.
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2: Active Comparator
TVT secur system positioning
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Procedure: TVT secur system positioning
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. Fine tuning of the tape tension by means of cough test prior to remove the inserter. Incision closure.
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Women with genuine urinary stress incontinence not associated with POP will be enrolled and randomized in two groups (arm 1 and arm 2). 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 two surgical treatment groups (arm 1 and 2). Patients of arm 1 will be treated with positioning of MiniArc (AMS, Minnetonka, MN, USA) whereas patients of arm 2 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.
Purpose
