Transobturator Verus Single Incision Slings

Urinary Incontinence, Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02599051
• Other study ID #: IRB 9034
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: January 2011

Study information

• Verified date: June 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Mini-arc
We will place a single incision sling at the time of surgery for stress urinary incontinence
• Monarc
We will place a transobturator sling at the time of surgery for stress urinary incontinence

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cecilia Calvo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Stress Urinary Incontinence	The primary outcome was presence of leakage during cough stress test(CST) on examination	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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