Urinary Incontinence, StressNCT02750878
Surgical Consent Process for Trans-obturator Tape Slings.
A study testing Informational Handout in people with Urinary Incontinence, Stress, run by Boston Urogynecology Associates at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- Informational Handout
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women ≥age 18
- Consented for TOT mid-urethral sling
- Able to read and understand English
Who cannot join
- History of surgical treatment for stress urinary incontinence using mid-urethral slings.
- Patients undergoing concomitant Trans-Obturator Post-Anal Sling (TOPAS) surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mount Auburn Hospital
Cambridge, Massachusetts, 02138
Kathleen Rogers, 617-354-5452, krogers2@mah.harvard.edu
About this study
Official title: A Randomized Controlled Trial of the Consent Process for Patients Undergoing Trans-obturator Tape Slings.
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.
Read the 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:
- Control Group: Participants will receive only the standard verbal TOT surgical consent counseling described above.
- 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
- Being tested
- Informational Handout
- Keywords
- Urinary Incontinence, Stress [C13.351.968.934.814.500]
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational HandoutOther
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants will receive only the standard verbal TOT surgical consent counseling. |
| Intervention group | Other | Participants will receive the standard verbal TOT surgical consent counseling plus a handout describing their surgical intervention Receives: Other: Informational Handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the day of Trans Obturator Tape surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionJul 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Urogynecology Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Elkadry, M.D., Boston Urogynecology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750878
- Sponsor's protocol ID
- 034-2015
- Status last verified
- Jan 2018
- First submitted
- 14 Apr 2016
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Consent Process for Patients Undergoing Trans-obturator Tape Slings.
- ClinicalTrials.gov ID
- NCT02750878
- Acronym / sponsor ID
- 034-2015
- Conditions
- Urinary Incontinence, Stress
- Keywords
- Urinary Incontinence, Stress [C13.351.968.934.814.500]
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Boston Urogynecology AssociatesUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Control Group: Participants will receive only the standard verbal TOT surgical consent counseling described above.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants will receive only the standard verbal TOT surgical consent counseling. |
| Intervention group | Other | Other: Informational HandoutParticipants will receive the standard verbal TOT surgical consent counseling plus a handout describing their surgical intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult women ≥age 18
- Consented for TOT mid-urethral sling
- Able to read and understand English
Key exclusion criteria (2 listed)
- History of surgical treatment for stress urinary incontinence using mid-urethral slings.
- Patients undergoing concomitant Trans-Obturator Post-Anal Sling (TOPAS) surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informational Handout | Other | Intervention group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational Handout in people with Urinary Incontinence, Stress, run by Boston Urogynecology Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Elkadry, MD (617-354-5452, eelkadry@mah.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.