Mid-Urethral Sling Tensioning Trial (MUST)

University of Calgary

Status: Completed

Conditions: Urinary Stress Incontinence

Treatments: Device: Retropubic Midurethral Sling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02480231

REB15-0455

Details and patient eligibility

About

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.

Enrollment: 318 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

318 participants in 2 patient groups

Babcock tensioning technique

Active Comparator group

Description:

Group for whom the retropubic mid-urethral sling was tensioned using a Babcock clamp.

Treatment:

Device: Retropubic Midurethral Sling

Scissor spacer technique

Active Comparator group

Description:

Group for whom the retropubic mid-urethral sling was tensioned using a surgical scissor as a spacer.

Treatment:

Device: Retropubic Midurethral Sling