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

NCT ID: NCT06801938

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Incontinence Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

The ability of perioperative methylene blue test and postoperative cystoscopy to detect complications in patients with stress urinary incontinence will be compared.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Perioperative Cystoscopy and Methylene Blue Test

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

postoperative cystoscopy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gaziosmanpaşa Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fatma Ketenci Gencer, Associate Professor

Role: CONTACT

+905416116469

Havva Betül Bacak, Specialist

Role: CONTACT

+905333610088

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fatma Ketenci Gencer, associate professor

Role: primary

+905416116469

Havva Betül Bacak, Specialist

Role: backup

+905333610088

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GaziosmanpasaTREHfkgfkg

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.