Surgical Consent Process for Trans-obturator Tape Slings.

Status unconfirmed · Not applicable

Conditions studied: Urinary Incontinence, Stress

In brief

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.

Key facts

Study ID

NCT02750878

Run by

Boston Urogynecology Associates

People needed

120

Starts

2015-11-01

Expected to finish

2020-07-01

Last updated by the study team

2018-01-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Mount Auburn Hospital — Cambridge, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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