Bladder IntegrityNCT05786391
Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy
A study testing Flat position, Trendelenburg position and Insufflation in people with Bladder Integrity and Bladder Function, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Objective: The investigators seek to compare the efficiency of the cystoscopy with two interventions: 1. patient position during the cystoscopy (Trendelenburg (head down) or flat) 2. Abdominal insufflation (insufflation versus no insufflation) Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bladder Integrity, Bladder Function, Ureteral Integrity
- What is being tested?
- Flat position, Trendelenburg position and Insufflation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2023to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient undergoing Planned cystoscopy in the benign gynecology service, (specifically undergoing a laparoscopic or robotic procedure requiring insufflation).
Who cannot join
- 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.
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- Undergoing extensive ureterolysis
- Blood loss more than 500 milliliters (mLs)
- Contra-indications to position change and insufflation
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy A Prospective Randomized Trial
Objective:
The investigators seek to compare the efficiency of the cystoscopy with two interventions:
- patient position during the cystoscopy (Trendelenburg (head down) or flat)
- Abdominal insufflation (insufflation versus no insufflation)
Read the detailed description
This is a randomized controlled trial assessing time to completion of cystoscopy in seconds after minimally invasive gynecologic surgery.
The investigators seek to compare the efficiency of the cystoscopy with two interventions:
- patient position during the cystoscopy (Trendelenburg (head down) or flat)
- Abdominal insufflation (insufflation versus no insufflation).
Both interventions are used as usual care and depend on surgeon preference without evidence why one would be faster at completing the cystoscopy. Also note that these two interventions are performed multiple times during the surgery itself and outside the cystoscopy procedure routinely. The investigator's main objective is to assess which intervention or combination of interventions is more efficient.
- Being tested
- Flat position, Trendelenburg position, Insufflation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flat positionOther
Flat patient position during the cystoscopy
Trendelenburg positionOther
Trendelenburg position (head down) during the cystoscopy
InsufflationDevice
Insufflation to 15 mm Hg
| Study group | Role | What they receive |
|---|---|---|
| Flat position with no Insufflation | Experimental | Not described Receives: Other: Flat position |
| Trendelenburg position and Insufflation | Experimental | insufflation to 15 mm Hg Receives: Other: Trendelenburg position; Device: Insufflation |
| Flat position and Insufflation | Experimental | Not described Receives: Other: Flat position; Device: Insufflation |
| Trendelenburg position with no Insufflation | Experimental | Not described Receives: Other: Trendelenburg position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From the start of the cystoscopy to the completion of the cystoscopy (about 4 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start11 Apr 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder IntegrityStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Jalloul, The University of Texas Health Science Center, Houston
- Investigators
- Randa Jalloul, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786391
- Sponsor's protocol ID
- HSC-MS-22-1081
- Status last verified
- Feb 2025
- First submitted
- 5 Mar 2023
- Last updated
- 24 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05786391
- Acronym / sponsor ID
- HSC-MS-22-1081
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Posted 24 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective:
The investigators seek to compare the efficiency of the cystoscopy with two interventions:
- patient position during the cystoscopy (Trendelenburg (head down) or flat)
- Abdominal insufflation (insufflation versus no insufflation)
Detailed description
This is a randomized controlled trial assessing time to completion of cystoscopy in seconds after minimally invasive gynecologic surgery.
The investigators seek to compare the efficiency of the cystoscopy with two interventions:
- patient position during the cystoscopy (Trendelenburg (head down) or flat)
- Abdominal insufflation (insufflation versus no insufflation).
Both interventions are used as usual care and depend on surgeon preference without evidence why one would be faster at completing the cystoscopy. Also note that these two interventions are performed multiple times during the surgery itself and outside the cystoscopy procedure routinely. The investigator's main objective is to assess which intervention or combination of interventions is more efficient.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Flat position with no Insufflation | Experimental | Other: Flat position |
| Trendelenburg position and Insufflation | Experimental | Other: Trendelenburg position, Device: Insufflationinsufflation to 15 mm Hg |
| Flat position and Insufflation | Experimental | Other: Flat position, Device: Insufflation |
| Trendelenburg position with no Insufflation | Experimental | Other: Trendelenburg position |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing Planned cystoscopy in the benign gynecology service, (specifically undergoing a laparoscopic or robotic procedure requiring insufflation).
Key exclusion criteria (9 listed)
- Pregnancy
- Known urologic anomaly
- Unplanned cystoscopy
- Cancer surgery
- Urogynecology surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flat positionFlat patient position during the cystoscopy | Other | Flat position and Insufflation, Flat position with no Insufflation |
| Trendelenburg positionTrendelenburg position (head down) during the cystoscopy | Other | Trendelenburg position and Insufflation, Trendelenburg position with no Insufflation |
| InsufflationInsufflation to 15 mm Hg | Device | Flat position and Insufflation, Trendelenburg position and Insufflation |
Primary outcome
Time in Seconds to Complete the Cystourethroscopy
Time frame: From the start of the cystoscopy to the completion of the cystoscopy (about 4 minutes)
Time in seconds to satisfactorily complete the cystourethroscopy (including visualization of the dome, the ureteral jets, the bladder mucosa, and the urethra).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randa Jalloul, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flat position, Trendelenburg position and Insufflation in people with Bladder Integrity and Bladder Function, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Seconds to Complete the Cystourethroscopy (time frame: From the start of the cystoscopy to the completion of the cystoscopy (about 4 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.