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Positioning & Insufflation Techniques for Bladder Function

N/A

Recruiting

Led By Randa Jalloul, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of the cystoscopy to the completion of the cystoscopy (about 17 minutes)

Awards & highlights

Study Summary

This trial compares two methods of cystoscopy to determine which is more effective.

Who is the study for?

This trial is for patients scheduled for benign gynecological cystoscopy, specifically those undergoing laparoscopic or robotic procedures that require insufflation. It's not suitable for individuals with heart disease, high blood pressure, kidney issues, diuretic use, excessive blood loss during surgery (>500 mL), pregnancy, known urinary anomalies, or if they're having cancer or urogynecology surgeries.Check my eligibility

What is being tested?

The study aims to determine the most efficient way to perform a cystoscopy by comparing patient positioning (flat vs. Trendelenburg) and the use of abdominal insufflation (air pumped into the abdomen). Participants will be assigned to one of these methods randomly.See study design

What are the potential side effects?

Potential side effects may include discomfort due to position changes such as in the Trendelenburg position where the head is lower than feet and risks associated with abdominal insufflation like bloating and pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of the cystoscopy to the completion of the cystoscopy (about 17 minutes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of the cystoscopy to the completion of the cystoscopy (about 17 minutes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of the cystoscopy to the completion of the cystoscopy (about 17 minutes) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time in seconds to complete the cystourethroscopy

Trial Design

4Treatment groups

Experimental Treatment

Group I: Trendelenburg position with no InsufflationExperimental Treatment1 Intervention

Group II: Trendelenburg position and InsufflationExperimental Treatment2 Interventions

insufflation to 15 mm Hg

Group III: Flat position with no InsufflationExperimental Treatment1 Intervention

Group IV: Flat position and InsufflationExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Insufflation

2012

Completed Phase 4

~130

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,824 Total Patients Enrolled

Randa Jalloul, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Insufflation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05786391 — N/A

Bladder Function Research Study Groups: Flat position with no Insufflation, Trendelenburg position with no Insufflation, Trendelenburg position and Insufflation, Flat position and Insufflation

Bladder Function Clinical Trial 2023: Insufflation Highlights & Side Effects. Trial Name: NCT05786391 — N/A

Insufflation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05786391 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the patient population limited to adults or are minors being considered as participants?

"According to the trial's parameters, individuals at least 18 years of age and no more than 90 are eligible for enrolment."

Answered by AI

Is it possible for me to sign up for this research project?

"In order to be included in this research project, potential participants must demonstrate urinary continence and be within the age range of 18-90. The clinical trial is looking for 136 individuals overall."

Answered by AI

Are there still vacancies to join this research effort?

"As indicated on clinicaltrials.gov, this medical trial is no longer recruiting participants. The study was posted on March 30th 2023 and the last edit was made on March 22nd 2023. However, there are alternative studies actively enrolling patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy

Randa Jalloul 2023. "Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05786391.