Evaluation of Perioperative Cystoscopy and Methylene Blue Test in Detecting Complications in TVT and TOT Procedures

February 4, 2025 updated by: Gaziosmanpasa Research and Education Hospital

Comparison of Complications Detected by Perioperative Cystoscopy Combined With Methylene Blue Test and Postoperative Cystoscopy in TVT and TOT Operations

Comparison of complications detected by perioperative cystoscopy combined with methylene blue test and postoperative cystoscopy in TVT and TOT operations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fatma Ketenci Gencer, associate professor
  • Phone Number: +905416116469
  • Email: fathma_k@hotmail.com

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34
        • Recruiting
        • Gaziosmanpaşa Training and Research Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Providing consent to participate in the study
  • Being between the ages of 18 and 85
  • Having stress urinary incontinence
  • No active cardiac disease
  • No connective tissue disorders (e.g., Marfan syndrome)
  • No known gynecological malignancy
  • BMI under 30
  • No chronic constipation
  • No inflammatory bowel disease

Exclusion Criteria:

  • Not providing consent to participate in the study
  • Being under 18 or over 85 years old
  • Not having stress urinary incontinence
  • Having active cardiac disease
  • Having connective tissue disorders (e.g., Marfan syndrome)
  • Having a known gynecological malignancy
  • Having a BMI over 30
  • Having chronic constipation
  • Having inflammatory bowel disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perioperative Methylene Blue and Cystoscopy with Postoperative Cystoscopy for Complication Detection
This arm includes patients with stress urinary incontinence who will undergo perioperative methylene blue test and cystoscopy, followed by postoperative cystoscopy to detect any complications. The aim is to assess the ability of these methods to identify complications in the postoperative period.
Procedure: Perioperative Cystoscopy and Methylene Blue Test
The ability of perioperative methylene blue and cystoscopy versus postoperative cystoscopy to detect complications will be compared in patients.
Other Names:
  • postoperative cystoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of complication detection
Time Frame: 6 months
Specifically, it would compare the ability of the perioperative methylene blue test and cystoscopy versus postoperative cystoscopy to detect complications. This measure will be used to evaluate the accuracy and effectiveness of both methods
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziosmanpasa Research and Education Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

January 25, 2025

First Submitted That Met QC Criteria

January 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GaziosmanpasaTREHfkgfkg

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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