NCT02480231

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

3.6 years

First QC Date

June 17, 2015

Last Update Submit

March 30, 2020

Conditions

Urinary Stress Incontinence

Keywords

Tension-Free Vaginal TapeSuburethral SlingsMidurethral SlingsMid-urethral slingurinary retention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Rate of discharge from hospital with on-going need for catheterization

    12 months

  • Duration of catheterization after surgery

    12 months

  • Questionnaire scores

    12 months

  • Pad test

    12 month

  • Uroflow parameters

    12 months

Study Arms (2)

Babcock tensioning technique

ACTIVE COMPARATOR

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

Device: Retropubic Midurethral Sling

Scissor spacer technique

ACTIVE COMPARATOR

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

Device: Retropubic Midurethral Sling

Interventions

Retropubic Midurethral SlingDEVICE
Also known as: Tension free Vaginal Tape
Babcock tensioning techniqueScissor spacer technique

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Hospital, University of Calgary

Calgary, Alberta, T2N 4J8, Canada

Location

Related Publications (1)

  • Brennand EA, Wu G, Houlihan S, Globerman D, Gagnon LH, Birch C, Hyakutake M, Carlson KV, Al-Shankiti H, Robert M, Lazare D, Kim-Fine S; Calgary Women's Pelvic Health Research Group. Two Intraoperative Techniques for Midurethral Sling Tensioning: A Randomized Controlled Trial. Obstet Gynecol. 2020 Sep;136(3):471-481. doi: 10.1097/AOG.0000000000004027.

    PMID: 32769657DERIVED

MeSH Terms

Conditions

Urinary Incontinence, StressUrinary Retention

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Erin A Brennand, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 24, 2015

Study Start

September 1, 2015

Primary Completion

April 1, 2019

Study Completion

March 1, 2020

Last Updated

April 1, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)