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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time in seconds to complete the cystourethroscopy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,931 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: Trendelenburg position and Insufflation, Flat position and Insufflation, Trendelenburg position with no Insufflation, Flat position with no 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
~51 spots leftby Dec 2025
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