Transobturator Verus Single Incision Slings

Study Overview
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Brief Summary
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A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling

Detailed Description
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Transobturator slings are one type of sling that has become standard treatment for stress urinary incontinence. However, this procedure involves a total of 3 incisions to perform. In contrast, single incision slings have been developed to treat stress urinary incontinence by using only one incision. However, to date the success and complications of these two procedures have not been compared or studied.

Official Title
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Transobturator Versus Single Incision Slings: 1 Year Results of a Randomized Control Trial

Conditions
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Urinary Incontinence, Stress

Intervention / Treatment
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* Device: Mini-arc
* Device: Monarc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with urodynamically proven stress urinary incontinence who were planning on undergoing surgery for treatment. Exclusion Criteria: Patients with prior incontinence surgery, a urodynamic diagnosis of intrinsic sphincter deficiency and mixed incontinence with a predominance of detrusor overactivity were excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monarc<br>Placement of a transobturator monarc sling for stress urinary incontinence | Device: Monarc<br>* We will place a transobturator sling at the time of surgery for stress urinary incontinence<br>* Other names: transobturator sling;|
| Experimental: Mini-arc<br>Placement of a single incision mini-arc sling for stress urinary incontinence | Device: Mini-arc<br>* We will place a single incision sling at the time of surgery for stress urinary incontinence<br>* Other names: single incision sling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Stress Urinary Incontinence | The primary outcome was presence of leakage during cough stress test(CST) on examination | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Questionnaire UDI-6 | Response to validated questionnaire: Urinary Distress Index(UDI-6) Measures symptoms on three subscales: 1. Irritative 2. Stress 3. Obstructive/Discomfort. The mean value of all questions answered is then multiplied by 25 for the actual score (range 0 to 100) Summary score - Add the scores from the 3 scales together to obtain the summary score (range 0 to 300) The higher the score the greater the perceived impact that pelvic floor dysfunction has on a patient's life. | 1 year | 
| Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence | Assess if the patient has any complaint of stress urinary incontinence after surgery in follow up visits. This will be history only, no examination. | 1 year | 
| Number of Participants Who Completed Self- Assessment of Cure | Self-assessment of cure is based on 5 point scale, cured, greatly improved, somewhat improved, not improved, and worsened. This is calculated by the number of patients that were analyzed. | 1 year | 
| Quality of Life Questionnaire IIQ-7 | Response to validated questionnaire: Incontinence Impact Questionnaire(IIQ-7) The IIQ measures the impact of urinary incontinence on activities roles, and emotional states. A mean score is derived from each domain, then transferred to give weight to each subscale. Subscale scores range from 0-100. The total IIQ score is calculated by adding the four subscales score with a range of 0-400 possible. A score closer to 0 represents activities not affected at all versus closer to 400 represent activities that were greatly affected. | 1 year | 
| Quality of Life Questionnaire ICIQ | Response to validated questionnaire: International Consultation on Incontinence Questionnaire(ICIQ). The ICIQ is a screening tool for incontinence. The scoring scale is 0-21, minimum 0, maximum 21. a higher score indicates greater impairment from incontinence. | 1 year |