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Surgical Consent Process for Trans-obturator Tape Slings.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02750878
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : January 19, 2018
Information provided by (Responsible Party):
Eman Elkadry, M.D., Boston Urogynecology Associates

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence, Stress Other: Informational Handout Not Applicable

Detailed Description:

This is a randomized controlled trial investigating whether adding an informational handout to the standard surgical consent will improve patient understanding, recall and satisfaction with their surgery. The primary outcome will be the patient's knowledge of her surgical details immediately before surgery. The secondary outcomes will be the patient's satisfaction, regret scale and the patient's postoperative knowledge of her surgery details.

A member of the research team will recruit eligible patients at their preoperative clinic visit during the signing of consent for their TOT surgery. Verbal counseling for the TOT surgical consent is the current standard of practice in the investigator's office. After the patient is counseled in the usual fashion and signs the consent for her planned TOT surgery, the patient will be offered participation in the study.

Eligible patients will be consented verbally by the investigators. After enrollment, patients will be randomized using a computer-generated block randomization scheme to allocate participants in a 1:1 ratio; randomization will be stratified by provider.

Participants will be randomized to one of two study arms:

  1. Control Group: Participants will receive only the standard verbal TOT surgical consent counseling described above.
  2. Intervention Group: Participants will receive the standard verbal TOT surgical consent counseling plus a handout describing their surgical intervention.

All participants will be asked to complete a baseline questionnaire at the enrollment visit. Participants randomized to the control group will be finished with this initial study visit after completing the baseline questionnaire. Participants randomized to the intervention arm will be given a handout describing the TOT procedure, risks and benefits, post-operative recovery and alternative treatment options, as discussed in the verbal surgical consent. The patient will be asked to read the handout and will then be given the handout to take home. The provider will answer any questions the patient has after reviewing the handout.

The next study encounter will occur in the preoperative area immediately prior to surgery. At this time all participants will be asked to complete a second questionnaire with questions similar to those in the baseline questionnaire.

The final study encounter will occur at the post-operative visit that occurs approximately six weeks after surgery. At this visit all participants will be asked to complete a final questionnaire. This questionnaire will be the same as the one administered immediately before surgery. All participants will also be asked to complete an additional questionnaire asking about satisfaction, regret and surgical experience.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized Controlled Trial of the Consent Process for Patients Undergoing Trans-obturator Tape Slings.
Actual Study Start Date : November 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control group
Participants will receive only the standard verbal TOT surgical consent counseling.
Intervention group
Participants will receive the standard verbal TOT surgical consent counseling plus a handout describing their surgical intervention
Other: Informational Handout

Primary Outcome Measures :
  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. [ Time Frame: On the day of Trans Obturator Tape surgery ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02750878

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Contact: Eman Elkadry, MD 617-354-5452
Contact: Hussein Warda, MD 617-354-5452

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United States, Massachusetts
Mount Auburn Hospital Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Kathleen Rogers    617-354-5452   
Sponsors and Collaborators
Boston Urogynecology Associates
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Responsible Party: Eman Elkadry, M.D., MD, Fellowship Director, Boston Urogynecology Associates Identifier: NCT02750878    
Other Study ID Numbers: 034-2015
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Eman Elkadry, M.D., Boston Urogynecology Associates:
Urinary Incontinence, Stress [C13.351.968.934.814.500]
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders