Surgical Consent Process for Trans-obturator Tape Slings.
Public ClinicalTrials.gov record NCT02750878. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Controlled Trial of the Consent Process for Patients Undergoing Trans-obturator Tape Slings.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02750878
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2015
- Primary completion
- Jun 30, 2019
- Completion
- Jun 30, 2020
- Last update posted
- Jan 18, 2018
2015 – 2020
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mount Auburn Hospital | Cambridge | Massachusetts | 02138 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Recently updated Urinary Incontinence, Stress trials
Other public records listing Urinary Incontinence, Stress. Sorted by last update posted; newest first. Not a recommendation.
- NCT04248283: Adjustable Continence Therapy (ACT) for the Treatment of Female SUI Recruiting
- NCT07202884: A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight Recruiting
- NCT06369922: TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence. Recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02750878, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 18, 2018 · Synced Sep 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02750878 live on ClinicalTrials.gov.