Surgical Consent Process for Trans-obturator Tape Slings.
A Randomized Controlled Trial of the Consent Process for Patients Undergoing Trans-obturator Tape Slings.
1 other identifier
interventional
120
1 country
1
Brief Summary
The purpose of this study is to determine if addition of a handout to the standard consent process for the trans-obturator tape (TOT) mid-urethral sling procedure will improve patients' understanding, recall and satisfaction with their procedure. The information provided in the handout will include the procedure details, the accompanying risks and benefits, as well as the expectations and alternatives to the TOT procedure. The aim of the investigators is to improve and standardize the current process for surgical consent for patients undergoing a mid-urethral sling procedure, specifically the TOT. The investigators hypothesize that addition of a handout will improve patient's preoperative comprehension by an absolute value of 10% compared to the standard consent process. The investigators further hypothesize that the handout will improve patient satisfaction and recall of the surgical procedure details post operatively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 14, 2016
CompletedFirst Posted
Study publicly available on registry
April 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedJanuary 19, 2018
January 1, 2018
3.7 years
April 14, 2016
January 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A knowledge questionnaire at the pre-operative holding area to measure the patients' knowledge regarding their Trans Obturator Tape surgery. The percentage of correct answers will be reported and analyzed.
On the day of Trans Obturator Tape surgery
Study Arms (2)
Control group
NO INTERVENTIONParticipants will receive only the standard verbal TOT surgical consent counseling.
Intervention group
OTHERParticipants will receive the standard verbal TOT surgical consent counseling plus a handout describing their surgical intervention
Interventions
Eligibility Criteria
You may qualify if:
- Adult women ≥age 18
- Consented for TOT mid-urethral sling
- Able to read and understand English
You may not qualify if:
- History of surgical treatment for stress urinary incontinence using mid-urethral slings.
- Patients undergoing concomitant Trans-Obturator Post-Anal Sling (TOPAS) surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Auburn Hospital
Cambridge, Massachusetts, 02138, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Fellowship Director
Study Record Dates
First Submitted
April 14, 2016
First Posted
April 26, 2016
Study Start
November 1, 2015
Primary Completion
July 1, 2019
Study Completion
July 1, 2020
Last Updated
January 19, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share