Urinary RetentionNCT03646136
Post Hysterectomy Benefits of Retained Cystoscopy Fluid
A study testing Retained fluid and Emptied fluid in people with Urinary Retention, run by University of Arizona at 1 site in United States.
Trial summary
The purpose of this research study is to compare outcomes for women in two study arms that include retaining the cystoscopy distending fluid after minimally invasive hysterectomy verses completely emptying the cystoscopy distending fluid. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention
- What is being tested?
- Retained fluid and Emptied fluid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2018to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients, greater than or equal to 18 years old
- English-speaking
- Undergoing laparoscopic or robotic hysterectomy for benign indications by one of the three minimally invasive gynecologic surgeons at Banner University Medical Center - Phoenix.
Who cannot join
- Preoperative indications of pelvic organ prolapse
- Preoperative indications of urinary incontinence
- Lower urologic (bladder or ureteric) injury identified at time of hysterectomy or during intraoperative cystoscopy
- Patients given any measure to aid in visualization of ureteral patency including dextrose, phenazopyridine, indigo carmine, methylene blue, sodium fluorescein, or furosemide.
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
About this study
Official title: Benefits of Retained Cystoscopy Fluid Following Benign Laparoscopic and Robotic Hysterectomy; A Randomized Controlled Trial
The purpose of this research study is to compare outcomes for women in two study arms that include retaining the cystoscopy distending fluid after minimally invasive hysterectomy verses completely emptying the cystoscopy distending fluid. The outcomes being measured for research purposes include the time spent to first spontaneous urination after surgery, rate of indwelling catheter insertion, length of recovery room stay, the amount of bladder discomfort immediately postoperative and over the first 24 hours postoperative, bladder symptoms over the first 24 hours postoperative, and patient satisfaction.
Read the detailed description
Acute urinary retention can be a common postoperative complication following hysterectomy. One of the many benefits of minimally invasive surgery is shorter hospital stay following a major procedure such as laparoscopic or robotic hysterectomy. An important postoperative milestone before discharge from the postoperative anesthesia care unit (PACU) is spontaneous voiding. If unable to spontaneously void due to urinary retention, insertion of an indwelling catheter may be required. Awaiting a spontaneous void in the recovery room can lead to longer hospital and PACU stays, greater cost, and patient dissatisfaction. At the conclusion of traditional laparoscopic or robotic-assisted hysterectomy, intraoperative cystoscopy is performed to evaluate for urologic injury. One possible strategy to more quickly facilitate a postoperative spontaneous void is to retain the cystoscopy distending fluid at conclusion of cystoscopy rather than emptying the bladder of the distending fluid. Although there is no published research investigating voiding time following laparoscopic or robotic hysterectomy using strategies such as backfilling the bladder before removal of the indwelling catheter or retaining the cystoscopy distending fluid following diagnostic cystoscopy.
- Conditions
- Urinary Retention
- Being tested
- Retained fluid, Emptied fluid
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retained fluidProcedure or surgery
Retained fluid
Emptied fluidProcedure or surgery
Emptied fluid
| Study group | Role | What they receive |
|---|---|---|
| Retained Cystoscopy Fluid | Experimental | Retained 200mL normal saline used for distending media following completion of diagnostic cystoscopy Receives: Procedure: Retained fluid |
| Cystoscopy Fluid Emptied | Active comparator | Emptied 200mL normal saline used for distending media following completion of diagnostic cystoscopy Receives: Procedure: Emptied fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to spontaneous void
Measure of time to spontaneous urination in the recovery room post hysterectomy. Time of urination is measured by the recovery room nurse from surgery end time.
Measured: From surgery end time up to 4 hours
Secondary outcomes (7)
Foley catheter insertion rate
Rate of patient's requiring Foley catheter insertion post hysterectomy if unable to spontaneously void in recovery room or anytime within 2 weeks postoperative.
Measured: 2 weeks
Length of recovery room stay
Measure of time from surgery end time to discharge home from the recovery room post hysterectomy.
Measured: From time of randomization up to 12 hours postoperative
4-Item Patient Satisfaction Measure
Self reported patient satisfaction survey related to ability to urinate in the recovery room, amount of time given to urinate, amount of time it took to urinate, and overall bladder discomfort. Each item is scored 1-5 (1=very satisfied, 5=very dissatisfied).
Measured: 12 hours
2-Item Patient Satisfaction Measure
Self reported patient satisfaction survey related to voiding function over 24 hours and overall bladder discomfort over 24 hours. Each item is scored 1-5 (1=very satisfied, 5=very dissatisfied).
Measured: 24 hours
3-Item Bladder Symptoms Measure
Self reported bladder symptom measure of burning, frequency, and urgency with voiding over the 24 hours postoperative. Measured as Yes/No.
Measured: 24 hours
2-Item Bladder pain Measure
Self reported bladder pain intensity on initial arrival to the recovery room and at discharge from the recovery room. Each item is scored 1-10 (1=no discomfort, 10=most discomfort).
Measured: 12 hours
3-Item Bladder pain Measure
Self reported bladder pain intensity over 24 hours postoperative, bladder discomfort before urination, and bladder discomfort after urination. Each item is scored 1-10 (1=no discomfort, 10=most discomfort).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start10 Oct 2018
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Sequential
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachael Bailey Smith, University of Arizona
- Investigators
- Rachael Smith, DO, Principal investigator, UofA College of Medicine Dept of OBG/Banner University Medical Center Phoenix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646136
- Sponsor's protocol ID
- UA IRB# 1808885089
- Status last verified
- Jan 2020
- First submitted
- 7 Aug 2018
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
PubMed 34184246Smith RB, Mahnert ND, Hu C, Steck-Bayat K, Womack AS, Mourad J. Impact of Retained Cystoscopy Fluid after Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Feb;28(2):288-296. doi: 10.1016/j.jmig.2020.05.024. Epub 2020 Jun 4.
PubMed 32505857
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Retained Cystoscopy Fluid Following Benign Laparoscopic and Robotic Hysterectomy; A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03646136
- Acronym / sponsor ID
- UA IRB# 1808885089
- Conditions
- Urinary Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to compare outcomes for women in two study arms that include retaining the cystoscopy distending fluid after minimally invasive hysterectomy verses completely emptying the cystoscopy distending fluid. The outcomes being measured for research purposes include the time spent to first spontaneous urination after surgery, rate of indwelling catheter insertion, length of recovery room stay, the amount of bladder discomfort immediately postoperative and over the first 24 hours postoperative, bladder symptoms over the first 24 hours postoperative, and patient satisfaction.
Detailed description
Acute urinary retention can be a common postoperative complication following hysterectomy. One of the many benefits of minimally invasive surgery is shorter hospital stay following a major procedure such as laparoscopic or robotic hysterectomy. An important postoperative milestone before discharge from the postoperative anesthesia care unit (PACU) is spontaneous voiding. If unable to spontaneously void due to urinary retention, insertion of an indwelling catheter may be required. Awaiting a spontaneous void in the recovery room can lead to longer hospital and PACU stays, greater cost, and patient dissatisfaction. At the conclusion of traditional laparoscopic or robotic-assisted hysterectomy, intraoperative cystoscopy is performed to evaluate for urologic injury. One possible strategy to more quickly facilitate a postoperative spontaneous void is to retain the cystoscopy distending fluid at conclusion of cystoscopy rather than emptying the bladder of the distending fluid. Although there is no published research investigating voiding time following laparoscopic or robotic hysterectomy using strategies such as backfilling the bladder before removal of the indwelling catheter or retaining the cystoscopy distending fluid following diagnostic cystoscopy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retained Cystoscopy Fluid | Experimental | Procedure: Retained fluidRetained 200mL normal saline used for distending media following completion of diagnostic cystoscopy |
| Cystoscopy Fluid Emptied | Active comparator | Procedure: Emptied fluidEmptied 200mL normal saline used for distending media following completion of diagnostic cystoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients, greater than or equal to 18 years old
- English-speaking
- Undergoing laparoscopic or robotic hysterectomy for benign indications by one of the three minimally invasive gynecologic surgeons at Banner University Medical Center - Phoenix.
Key exclusion criteria (4 listed)
- Preoperative indications of pelvic organ prolapse
- Preoperative indications of urinary incontinence
- Lower urologic (bladder or ureteric) injury identified at time of hysterectomy or during intraoperative cystoscopy
- Patients given any measure to aid in visualization of ureteral patency including dextrose, phenazopyridine, indigo carmine, methylene blue, sodium fluorescein, or furosemide.
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 |
|---|---|---|
| Retained fluidRetained fluid | Procedure or surgery | Retained Cystoscopy Fluid |
| Emptied fluidEmptied fluid | Procedure or surgery | Cystoscopy Fluid Emptied |
Primary outcome
Time to spontaneous void
Time frame: From surgery end time up to 4 hours
Measure of time to spontaneous urination in the recovery room post hysterectomy. Time of urination is measured by the recovery room nurse from surgery end time.
7 secondary outcomes
Foley catheter insertion rate
Time frame: 2 weeks
Length of recovery room stay
Time frame: From time of randomization up to 12 hours postoperative
4-Item Patient Satisfaction Measure
Time frame: 12 hours
2-Item Patient Satisfaction Measure
Time frame: 24 hours
3-Item Bladder Symptoms Measure
Time frame: 24 hours
2-Item Bladder pain Measure
Time frame: 12 hours
3-Item Bladder pain Measure
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Derived from this study: PubMed 34184246Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
- Derived from this study: PubMed 32505857Smith RB, Mahnert ND, Hu C, Steck-Bayat K, Womack AS, Mourad J. Impact of Retained Cystoscopy Fluid after Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Feb;28(2):288-296. doi: 10.1016/j.jmig.2020.05.024. Epub 2020 Jun 4.
- Individual participant dataSharing planned: No
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Postpartum Urinary Retention
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Pelvic Health Electrically Evoked Recording (PEER) 2 Study
Overactive Bladder, Fecal Incontinence
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Active, not recruiting
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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.
Rachael Smith, DO principal investigator
UofA College of Medicine Dept of OBG/Banner University Medical Center Phoenix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retained fluid and Emptied fluid in people with Urinary Retention, run by University of Arizona 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 3 inclusion and 4 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 29 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 to spontaneous void (time frame: From surgery end time up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03646136, which also lists 2 linked publications.
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 29 Jan 2020.