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

NCT06801938 | Recruiting

• 1 other identifier: GaziosmanpasaTREHfkgfkg
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Incontinence Stress

Keywords

tvt; tot; cystoscopy

Outcome Measures

Primary Outcomes (1)

• rate of complication detection

  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

Study Arms (1)

Perioperative Methylene Blue and Cystoscopy with Postoperative Cystoscopy for Complication Detection

EXPERIMENTAL

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

Interventions

Perioperative Cystoscopy and Methylene Blue Test PROCEDURE

The ability of perioperative methylene blue and cystoscopy versus postoperative cystoscopy to detect complications will be compared in patients.

Also known as: postoperative cystoscopy

Perioperative Methylene Blue and Cystoscopy with Postoperative Cystoscopy for Complication Detection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpaşa Training and Research Hospital

Istanbul, 34, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fatma Ketenci Gencer, Associate Professor

CONTACT

+905416116469; fathma_k@hotmail.com

Havva Betül Bacak, Specialist

CONTACT

+905333610088; hbbacak90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The ability of perioperative methylene blue test and postoperative cystoscopy to detect complications in patients with stress urinary incontinence will be compared.

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: January 30, 2025
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)