Urinary RetentionPOVAGSNCT04198285
Post-Operative Voiding After Gynecological Surgery Trial
A study testing Retrograde bladder filling in people with Urinary Retention and Postoperative Complications, run by Women's College Hospital at 1 site in Canada.
Trial summary
To determine whether partially filling the bladder after outpatient gynaecological laparoscopy expedites time to first void and discharge. Methods: A single site, single-blinded, randomized control trial in which eligible patients undergo partial retrograde bladder filling immediately post-operatively compared to… 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, Postoperative Complications, Surgery
- What is being tested?
- Retrograde bladder filling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2020to 27 Apr 2020
- 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
- Women
- Undergoing elective laparoscopy for a gynaecological indication
- Plan for same day discharge
- Able to provide informed consent
Who cannot join
- Pregnancy
- Undergoing procedure for pelvic organ prolapse, stress urinary incontinence, or nerve detrapment
- Prior hysterectomy, or incontinence/pelvic organ prolapse procedures
- Pre-existing voiding dysfunction
- Known recurrent urinary tract infections
- Known genito-urinary malformations
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- Known for neuromuscular disorders such as multiple sclerosis
- Use of anticholinergic medication
- Intraoperative bladder related complications
- Need for discharge with indwelling foley catheter
- Patients requiring overnight admission for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Operative Voiding After Gynecological Surgery (POVAGS) Trial: a Randomized Controlled Trial on Retrograde Bladder Filling After Outpatient Gynaecological Laparoscopy
To determine whether partially filling the bladder after outpatient gynaecological laparoscopy expedites time to first void and discharge. Methods: A single site, single-blinded, randomized control trial in which eligible patients undergo partial retrograde bladder filling immediately post-operatively compared to bladder drainage and foley catheter removal. Primary outcome is time to first void, secondary outcomes include time to discharge, post-operative complications and patient satisfaction.
- Conditions
- Urinary Retention, Postoperative Complications, Surgery
- Being tested
- Retrograde bladder filling
- Keywords
- laparoscopy, urinary retention
- Medical subject headings
- Urinary Retention, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde bladder fillingProcedure or surgery
The bladder will be filled with a large syringe through the urinary catheter (which is left in place for the surgery) with 200mL of sterile saline, and then the catheter will be removed.
| Study group | Role | What they receive |
|---|---|---|
| Retrograde filled | Experimental | This arm will contain patients who had retrograde bladder filling upon completion of surgery with 200 milliliters (mL) of sterile saline. Receives: Procedure: Retrograde bladder filling |
| Control | No intervention | This arm will contain patients who simply had the urinary catheter removed upon completion of surgery, and were left with an empty bladder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first void
Time in minutes from arrival in post-operative anesthesia unit (PACU) to first void
Measured: 3 hours
Secondary outcomes (4)
Time to discharge
Time in minutes from arrival in PACU to discharge from PACU
Measured: 8 hours
Post-operative complications
Urinary tract infections, or other reported complications
Measured: 1 week following surgery
Patient satisfaction
Patients' subjective experience in both groups regarding time spent in PACU and first postoperative week
Measured: 1 week
Post-operative pain
visual analogue scale of postoperative pain, assessed in PACU
Measured: Assessed at the 1 hour mark
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start10 Jan 2020
- Primary completion27 Apr 2020
- Study completion27 Apr 2020
Why it stopped: Due to cancellation of elective surgery (Covid-19)
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.
- 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathon Solnik, Women's College Hospital
- Investigators
- Ally Murji, MD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198285
- Sponsor's protocol ID
- 2019-0110-E
- Acronym
- POVAGS
- Status last verified
- Aug 2020
- First submitted
- 12 Dec 2019
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moawad G, Tyan P, Marfori C, Abi Khalil E, Park D. Effect of postoperative partial bladder filling after minimally invasive hysterectomy on postanesthesia care unit discharge and cost: a single-blinded, randomized controlled trial. Am J Obstet Gynecol. 2019 Apr;220(4):367.e1-367.e7. doi: 10.1016/j.ajog.2018.12.034. Epub 2019 Jan 9.
PubMed 30639089Zakhari A, Paek W, Chan W, Edwards D, Matelski J, Solnik MJ, Murji A. Retrograde Bladder Filling after Laparoscopic Gynecologic Surgery: A Double-blind Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 May;28(5):1006-1012.e1. doi: 10.1016/j.jmig.2020.09.019. Epub 2020 Oct 3.
PubMed 33017685
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Voiding After Gynecological Surgery (POVAGS) Trial: a Randomized Controlled Trial on Retrograde Bladder Filling After Outpatient Gynaecological Laparoscopy
- ClinicalTrials.gov ID
- NCT04198285
- Acronym / sponsor ID
- POVAGS / 2019-0110-E
- Conditions
- Urinary Retention, Postoperative Complications, Surgery
- Keywords
- laparoscopy, urinary retention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to cancellation of elective surgery (Covid-19)
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 27 Apr 2020 (actual)
- First posted
- 13 Dec 2019 (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.
To determine whether partially filling the bladder after outpatient gynaecological laparoscopy expedites time to first void and discharge. Methods: A single site, single-blinded, randomized control trial in which eligible patients undergo partial retrograde bladder filling immediately post-operatively compared to bladder drainage and foley catheter removal. Primary outcome is time to first void, secondary outcomes include time to discharge, post-operative complications and patient satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrograde filled | Experimental | Procedure: Retrograde bladder fillingThis arm will contain patients who had retrograde bladder filling upon completion of surgery with 200 milliliters (mL) of sterile saline. |
| Control | No intervention | –This arm will contain patients who simply had the urinary catheter removed upon completion of surgery, and were left with an empty bladder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women
- Undergoing elective laparoscopy for a gynaecological indication
- Plan for same day discharge
- Able to provide informed consent
Key exclusion criteria (11 listed)
- Pregnancy
- Undergoing procedure for pelvic organ prolapse, stress urinary incontinence, or nerve detrapment
- Prior hysterectomy, or incontinence/pelvic organ prolapse procedures
- Pre-existing voiding dysfunction
- Known recurrent urinary tract infections
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 |
|---|---|---|
| Retrograde bladder fillingThe bladder will be filled with a large syringe through the urinary catheter (which is left in place for the surgery) with 200mL of sterile saline, and then the catheter will be removed. | Procedure or surgery | Retrograde filled |
Primary outcome
Time to first void
Time frame: 3 hours
Time in minutes from arrival in post-operative anesthesia unit (PACU) to first void
4 secondary outcomes
Time to discharge
Time frame: 8 hours
Post-operative complications
Time frame: 1 week following surgery
Patient satisfaction
Time frame: 1 week
Post-operative pain
Time frame: Assessed at the 1 hour mark
Results and safety
The study was stopped early (reason given: Due to cancellation of elective surgery (Covid-19)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Background: PubMed 30639089Moawad G, Tyan P, Marfori C, Abi Khalil E, Park D. Effect of postoperative partial bladder filling after minimally invasive hysterectomy on postanesthesia care unit discharge and cost: a single-blinded, randomized controlled trial. Am J Obstet Gynecol. 2019 Apr;220(4):367.e1-367.e7. doi: 10.1016/j.ajog.2018.12.034. Epub 2019 Jan 9.
- Derived from this study: PubMed 33017685Zakhari A, Paek W, Chan W, Edwards D, Matelski J, Solnik MJ, Murji A. Retrograde Bladder Filling after Laparoscopic Gynecologic Surgery: A Double-blind Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 May;28(5):1006-1012.e1. doi: 10.1016/j.jmig.2020.09.019. Epub 2020 Oct 3.
- 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.
Ally Murji, MD principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrograde bladder filling in people with Urinary Retention and Postoperative Complications, run by Women's College Hospital at 1 site in Canada.
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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 18 Aug 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 Canada. 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 was stopped early (reason given: Due to cancellation of elective surgery (Covid-19)). Results are not available in the source record.
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 first void (time frame: 3 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 NCT04198285, 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 18 Aug 2020; AzTrials last refreshed its copy on 30 Oct 2026.