Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy

NCT05786391 | Completed Results FDA Device

• 1 other identifier: HSC-MS-22-1081
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The investigators seek to compare the efficiency of the cystoscopy with two interventions:

1. 1.patient position during the cystoscopy (Trendelenburg (head down) or flat)
2. 2.Abdominal insufflation (insufflation versus no insufflation)

Conditions

Bladder Integrity; Bladder Function; Ureteral Integrity; Ureteral Function

Outcome Measures

Primary Outcomes (1)

• Time in Seconds to Complete the Cystourethroscopy

  Time in seconds to satisfactorily complete the cystourethroscopy (including visualization of the dome, the ureteral jets, the bladder mucosa, and the urethra).

  From the start of the cystoscopy to the completion of the cystoscopy (about 4 minutes)

Study Arms (4)

Flat position with no Insufflation

EXPERIMENTAL

Other: Flat position

Trendelenburg position and Insufflation

EXPERIMENTAL

insufflation to 15 mm Hg

Other: Trendelenburg position; Device: Insufflation

Flat position and Insufflation

EXPERIMENTAL

Other: Flat position; Device: Insufflation

Trendelenburg position with no Insufflation

EXPERIMENTAL

Other: Trendelenburg position

Interventions

Flat position OTHER

Flat patient position during the cystoscopy

Flat position and Insufflation; Flat position with no Insufflation

Trendelenburg position OTHER

Trendelenburg position (head down) during the cystoscopy

Trendelenburg position and Insufflation; Trendelenburg position with no Insufflation

Insufflation DEVICE

Insufflation to 15 mm Hg

Flat position and Insufflation; Trendelenburg position and Insufflation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patient undergoing Planned cystoscopy in the benign gynecology service, (specifically undergoing a laparoscopic or robotic procedure requiring insufflation).

You may not qualify if:

• Pregnancy
• Known urologic anomaly
• Unplanned cystoscopy
• Cancer surgery
• Urogynecology surgery
• comorbidities including cardiac disease, chronic hypertension, any stage kidney disease (including abnormal creatinine level), and use of diuretics.
• Undergoing extensive ureterolysis
• Blood loss more than 500 milliliters (mLs)
• Contra-indications to position change and insufflation

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Head-Down Tilt; Insufflation

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diagnostic Techniques and Procedures; Diagnosis; Therapeutics

Results Point of Contact

• Title: Randa J Jalloul, MD
• Organization: The University of Texas Health Science Center at Houston

Randa.J.Jalloul@uth.tmc.edu

713-566-5749

Study Officials

• Randa Jalloul, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 27, 2023
• Study Start: April 11, 2023
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)