Recruiting

Observational Study

Sponsor:

Boston Urogynecology Associates

Code:

NCT02750878

Conditions

Urinary Incontinence, Stress

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Informational Handout

Study Details

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.

Conditions

Urinary Incontinence, Stress

Study ID

NCT02750878

Start date

Nov, 2015

Status verified date

Jan, 2018

Completion date

Jul, 2020

Anticipated

Primary completion date

Jul, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult women ≥age 18
  • Consented for TOT mid-urethral sling
  • Able to read and understand English

Exclusion Criteria:

  • History of surgical treatment for stress urinary incontinence using mid-urethral slings.
  • Patients undergoing concomitant Trans-Obturator Post-Anal Sling (TOPAS) surgery.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Control group

Participants will receive only the standard verbal TOT surgical consent counseling.

other: Intervention group

Participants will receive the standard verbal TOT surgical consent counseling plus a handout describing their surgical intervention

Interventions

Informational Handout

Primary outcome measure

  • 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. [ Time Frame: On the day of Trans Obturator Tape surgery ]

Central Contacts and Locations

Central contacts

Eman Elkadry, MD

617-354-5452eelkadry@mah.harvard.edu

Hussein Warda, MD

617-354-5452hwarda@mah.harvard.edu

Locations

Mount Auburn Hospital

Recruiting

Cambridge, Massachusetts, United States, 02138

Contacts

Kathleen Rogers

617-354-5452krogers2@mah.harvard.edu

More Information

Sponsor

Boston Urogynecology Associates

Last update posted

Jan 19, 2018

Last verified

Jan, 2018

Keywords

  • Urinary Incontinence, Stress [C13.351.968.934.814.500]

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Urogynecology Associates on 2018-01-19.