Mid-Urethral Sling Tensioning Trial

Urinary Stress Incontinence Clinical Trial

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Official title:

Mid-Urethral Sling Tensioning Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480231
• Other study ID #: REB15-0455
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: March 2020

Study information

• Verified date: March 2020
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective randomized clinical trial comparing two methods of intra-operative tensioning of retropubic midurethral slings for stress urinary incontinence. Primary outcome is rate of abnormal bladder function. Secondary outcomes include validated quality of life scores, physical exam findings, and rates of immediate post operative voiding dysfunction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: March 2020
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Age 18 or older

• Women who have elected for surgical management of symptomatic urinary incontinence

• Ability to read & write in English

• Other prolapse surgery at time of sling placement is allowed

• Must consent to participation in trial

Exclusion Criteria:

• Women with a prior incontinence procedure

• Clinically obvious, but non-symptomatic stress urinary incontinence (latent stress incontinence)

• Declines participation in trial

• Women with existing urinary retention or significant overactive bladder (requiring medication)

Related Conditions & MeSH terms

• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

Device:
• Retropubic Midurethral Sling

Locations

Country	Name	City	State
Canada	Foothills Hospital, University of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Boston Scientific Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal Bladder Function	Abnormal post-operative bladder function a composite outcome assessed at 12 months after surgery. It is one or more of the following: 1) significantly bothersome stress incontinence or over active bladder symptoms after surgery as measured by questions 1, 2, 3 of the Urogential Distress Inventory (UDI-6) 2) a positive cough stress test in the office, 3) re-treatment for stress urinary incontinence (repeat surgery or pessary use), 4) post-operative urinary retention (presence of self-catheterization at 6 weeks post-operatively or beyond, or therapeutic intervention for retention at any time during the 12 months after, such as pelvic floor physiotherapy, sling lysis, urethrolysis, or sacral nerve stimulation.	1 year post operative
Secondary	Rate of discharge from hospital with on-going need for catheterization		12 months
Secondary	Duration of catheterization after surgery		12 months
Secondary	Questionnaire scores	standardized questionnaire scores (UDI-6, Incontinence Impact Questionnaire, International Consultation on Incontinence Modular Questionnaire)	12 months
Secondary	Pad test	Standardized 1 hour pad test values	12 month
Secondary	Uroflow parameters	Maximum urine flow rate, post void residual	12 months