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

University Magna Graecia

Status and phase: Completed; Phase 4

Conditions: Urinary Incontinence

Treatments: Procedure: Tension free vaginal ttape; Procedure: Ajust positioning; Procedure: MiniArc positioning; Procedure: TVT secur system positioning

Study type: Interventional

Funder types: Other

Identifiers

NCT00751088

04/2008

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• genuine stress incontinence

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

1

Active Comparator group

Description:

Patients treated with Ajust positioning

Treatment:

Procedure: Ajust positioning

2

Active Comparator group

Description:

Patients treated with MiniArc positioning

Treatment:

Procedure: MiniArc positioning

3

Active Comparator group

Description:

Patients treated with TVT secur system

Treatment:

Procedure: TVT secur system positioning

4

Active Comparator group

Description:

Patients treated with tension free vaginal tape

Treatment:

Procedure: Tension free vaginal ttape