Transobturator Verus Single Incision Slings

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

A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence, Stress
• Intervention / Treatment: Device: Monarc; Device: Mini-arc

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cecilia Calvo
• Investigators: Principal Investigator: G Willy Davila, MD, Cleveland Clinic Florida

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: November 3, 2015
• First Submitted That Met QC Criteria: November 5, 2015
• First Posted (Estimated): November 6, 2015

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: IRB 9034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO