Surgical Consent Process for Trans-obturator Tape Slings.

NCT ID: NCT02750878

Last Updated: 2018-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2020-07-31

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.

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.

Conditions

Urinary Incontinence, Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

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

Group Type: OTHER

Informational Handout

Intervention Type: OTHER

Interventions

Informational Handout

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Urogynecology Associates

OTHER

Sponsor Role: lead

Responsible Party

Eman Elkadry, M.D.

MD, Fellowship Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mount Auburn Hospital

Cambridge, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Eman Elkadry, MD

Role: CONTACT

eelkadry@mah.harvard.edu

617-354-5452

Hussein Warda, MD

Role: CONTACT

hwarda@mah.harvard.edu

617-354-5452

Facility Contacts

Kathleen Rogers

Role: primary

krogers2@mah.harvard.edu

617-354-5452

Other Identifiers

034-2015

Identifier Type: -

Identifier Source: org_study_id