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

Plain-language guide to NCT06801938: not phased interventional trial of Methylene blue (non-peptide stack partner), 58 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06801938
Phase
not phased
Status
recruiting participants
Start
2025-01-01
Completion (planned or actual)
2025-06-01
Participants
58 (estimated)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Incontinence Stress
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Methylene blue (non-peptide stack partner).

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

It had 1 arm (groups): 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.

The registry classes the interventions as procedure.

Who Took Part

Enrollment: 58 planned participants were the target.

It was open to women only aged from 18 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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).

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: not providing consent to participate in the study; being under 18 or over 85 years old; not having stress urinary incontinence.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Methylene blue (non-peptide stack partner) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-01-01 with completion listed for 2025-06-01.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: rate of complication detection (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a not phased trial of Methylene blue (non-peptide stack partner) in 58 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.

Our Notes on the Compound

Methylene blue (non-peptide stack partner): Described as an electron cycler, not just a dye.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.