Transobturator Verus Single Incision Slings
- Conditions
- Urinary Incontinence, Stress
- Interventions
- Device: Mini-arcDevice: Monarc
- Registration Number
- NCT02599051
- Lead Sponsor
- Cecilia Calvo
- Brief Summary
A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 98
- Patients with urodynamically proven stress urinary incontinence who were planning on undergoing surgery for treatment.
- Patients with prior incontinence surgery, a urodynamic diagnosis of intrinsic sphincter deficiency and mixed incontinence with a predominance of detrusor overactivity were excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mini-arc Mini-arc Placement of a single incision mini-arc sling for stress urinary incontinence Monarc Monarc Placement of a transobturator monarc sling for stress urinary incontinence
- Primary Outcome Measures
Name Time Method Objective Stress Urinary Incontinence 1 year The primary outcome was presence of leakage during cough stress test(CST) on examination
- Secondary Outcome Measures
Name Time Method Quality of Life Questionnaire ICIQ 1 year 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.
Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence 1 year Assess if the patient has any complaint of stress urinary incontinence after surgery in follow up visits. This will be history only, no examination.
Quality of Life Questionnaire IIQ-7 1 year 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.
Quality of Life Questionnaire UDI-6 1 year 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.
Number of Participants Who Completed Self- Assessment of Cure 1 year 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.