Urinary RetentionNCT05396430
Duration of Urinary Catheter Treatment After Cesarean Delivery Under Spinal Anesthesia
A study testing Urinary catheter in people with Urinary Retention and Cesarean Section Complications, run by Women's Hospital HUS at 1 site in Finland.
Trial summary
In this study a total of 150 parturients undergoing cesarean delivery under spinal anesthesia will be randomized to have their urinary catheters kept in place for 8, 10 or 12 hours. The incidence of urinary retention and interventions needed for any potential urinary retention will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention, Cesarean Section Complications
- What is being tested?
- Urinary catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2023to 31 Aug 2023
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- After informed consent, signed the participation form (volunteered for the study)
- Cesarean section
- Spinal anesthesia
Who cannot join
- Prior neuraxial analgesia (epidural or spinal) for attempted labour
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Recovery After Cesarean Delivery: Duration of Urinary Catheter Treatment
In this study a total of 150 parturients undergoing cesarean delivery under spinal anesthesia will be randomized to have their urinary catheters kept in place for 8, 10 or 12 hours. The incidence of urinary retention and interventions needed for any potential urinary retention will be assessed.
Read the detailed description
In this study a total of 150 parturients undergoing cesarean delivery under spinal anesthesia will be randomized to have their urinary catheters kept in place for 8, 10 or 12 hours. The incidence of urinary retention and interventions needed for any potential urinary retention will be assessed.
- Conditions
- Urinary Retention, Cesarean Section Complications
- Being tested
- Urinary catheter
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary catheterDevice
Duration of planned urinary cathterization following cesarean delivery
| Study group | Role | What they receive |
|---|---|---|
| Urinary catheter 8 hours | Experimental | The urinary cathter is to be removed at 8 hours after the end of surgery Receives: Device: Urinary catheter |
| Urinary catheter 10 hours | Experimental | The urinary cathter is to be removed at 10 hours after the end of surgery Receives: Device: Urinary catheter |
| Urinary catheter 12 hours | Active comparator | The urinary cathter is to be removed at 12 hours after the end of surgery Receives: Device: Urinary catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of spontaneous voiding of bladder
Assessed by ultrasound bladder scanner after attempted voiding of the bladder
Measured: 6-12 hours after removal of the urinary catheter
Secondary outcomes (3)
Amount of residual urine in the bladder
Assessed by ultrasound
Measured: 6-12 hours after removal of the urinary catheter
Need for standard in-house medications to help spontaneous voiding of the bladder
Amount of medicines given
Measured: 6-12 hours after removal of the urinary catheter
Need for re-cathterization of the bladder
Measured: 6-12 hours after removal of the urinary catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Jan 2023
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The parturients are randomized into 3 different treatment arms with different duration of planned urinary catheter treatment
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital HUS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antti Vaananen, Women's Hospital HUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396430
- Sponsor's protocol ID
- Tutkimussuunnitelma25032022
- Status last verified
- Apr 2023
- First submitted
- 27 May 2022
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Recovery After Cesarean Delivery: Duration of Urinary Catheter Treatment
- ClinicalTrials.gov ID
- NCT05396430
- Acronym / sponsor ID
- Tutkimussuunnitelma25032022
- Conditions
- Urinary Retention, Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Women's Hospital HUSUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 31 May 2022 (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.
In this study a total of 150 parturients undergoing cesarean delivery under spinal anesthesia will be randomized to have their urinary catheters kept in place for 8, 10 or 12 hours. The incidence of urinary retention and interventions needed for any potential urinary retention will be assessed.
Detailed description
In this study a total of 150 parturients undergoing cesarean delivery under spinal anesthesia will be randomized to have their urinary catheters kept in place for 8, 10 or 12 hours. The incidence of urinary retention and interventions needed for any potential urinary retention will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The parturients are randomized into 3 different treatment arms with different duration of planned urinary catheter treatment
| Arm | Type | Receives |
|---|---|---|
| Urinary catheter 8 hours | Experimental | Device: Urinary catheterThe urinary cathter is to be removed at 8 hours after the end of surgery |
| Urinary catheter 10 hours | Experimental | Device: Urinary catheterThe urinary cathter is to be removed at 10 hours after the end of surgery |
| Urinary catheter 12 hours | Active comparator | Device: Urinary catheterThe urinary cathter is to be removed at 12 hours after the end of surgery |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- After informed consent, signed the participation form (volunteered for the study)
- Cesarean section
- Spinal anesthesia
Key exclusion criteria (1 listed)
- Prior neuraxial analgesia (epidural or spinal) for attempted labour
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 |
|---|---|---|
| Urinary catheterDuration of planned urinary cathterization following cesarean delivery | Device | Urinary catheter 10 hours, Urinary catheter 12 hours, Urinary catheter 8 hours |
Primary outcome
Success of spontaneous voiding of bladder
Time frame: 6-12 hours after removal of the urinary catheter
Assessed by ultrasound bladder scanner after attempted voiding of the bladder
3 secondary outcomes
Amount of residual urine in the bladder
Time frame: 6-12 hours after removal of the urinary catheter
Need for standard in-house medications to help spontaneous voiding of the bladder
Time frame: 6-12 hours after removal of the urinary catheter
Need for re-cathterization of the bladder
Time frame: 6-12 hours after removal of the urinary catheter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary catheter in people with Urinary Retention and Cesarean Section Complications, run by Women's Hospital HUS at 1 site in Finland.
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 1 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: status not confirmed, as of the sponsor's last update on 26 Apr 2023. 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 Finland. 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?
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?
Success of spontaneous voiding of bladder (time frame: 6-12 hours after removal of the urinary catheter). 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 26 Apr 2023.