Urinary RetentionPURNCT04187365
Optimizing the Management of Postpartum Urinary Retention
A study testing Duration of Indwelling Catheter in people with Urinary Retention, run by Northwestern University at 1 site in United States.
Trial summary
A study aimed at characterizing the comparing duration of catheterization for treatment of postpartum urinary retention (PUR) and characterizing short and long-term pelvic floor symptoms in women who have PUR. 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?
- Duration of Indwelling Catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2019to 27 Feb 2022
- 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
- Age greater than or equal to 18.
- Vaginal or cesarean delivery at term (37 weeks gestational age or later) of live-born infants.
- English or Spanish speaking and reading.
Who cannot join
- Adults unable to consent.
- Women under the age of 18.
- Women who are currently pregnant (All women in the study will have already delivered).
- Prisoners or detained individuals.
- Women who chronically use a urinary catheter for another medical condition.
- Women with a neurological disease with bladder manifestations (examples: Cerebrovascular accidents, Multiple sclerosis, Parkinson disease, cerebral palsy).
Show all 10Show fewer
- Women with preeclampsia requiring magnesium treatment for seizure prevention.
- Women with prior PUR
- Women on anticholinergic medications.
- Women who are actively being treated for a UTI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing the Management of Postpartum Urinary Retention: Postpartum Urinary Retention (PUR) Study
A study aimed at characterizing the comparing duration of catheterization for treatment of postpartum urinary retention (PUR) and characterizing short and long-term pelvic floor symptoms in women who have PUR.
Read the detailed description
The purpose of the study is to compare clinical outcomes of women with bladder distension injuries due to postpartum urinary retention (PUR) who have varying duration of catheterization for initial treatment of postpartum urinary retention.
Hypotheses
- Longer duration of therapeutic catheterization will be associated with resolution of postpartum voiding dysfunction in women who sustain severe bladder distension injuries due to postpartum urinary retention. Definition of resolution of postpartum voiding dysfunction:
- A post void residual volume of less than half of initial instilled volume on the first retrograde voiding trial, AND B. No need for re-treatment for urinary retention within 1 week
- The incidence of postpartum urinary retention (PUR) will vary by route of delivery, with operative vaginal delivery having the highest incidence.
- Risk factors for PUR will be related to intrapartum and delivery conditions
- Conditions
- Urinary Retention
- Being tested
- Duration of Indwelling 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.
Duration of Indwelling CatheterOther
Foley catheter
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 (NonSevere PUR and women without PUR) | No intervention | Women in GROUP 1 will be prospectively observed to characterize their clinical outcomes. |
| GROUP 2 (Severe PUR) | Experimental | Women in GROUP 2 will be a randomized to either 3 or 7 days of indwelling catheterization. Receives: Other: Duration of Indwelling Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate whether 3 days of indwelling catheterization is inferior to 7 days in resolving postpartum urinary retention.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start22 Nov 2019
- Primary completion27 Feb 2022
- Study completion27 Feb 2022
Why it stopped: Study was terminated prematurely due to challenges with recruitment and feasibility of continuing the study
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.
- More trials run by Northwestern UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- In Arm 2, women with severe postpartum urinary retention will be randomized to 3 or 7 days of foley catheter.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Collins, Northwestern University
- Investigators
- Sarah Collins, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187365
- Sponsor's protocol ID
- STU00210382
- Acronym
- PUR
- Status last verified
- Apr 2022
- First submitted
- 3 Dec 2019
- Last updated
- 20 Apr 2022
- 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 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Management of Postpartum Urinary Retention: Postpartum Urinary Retention (PUR) Study
- ClinicalTrials.gov ID
- NCT04187365
- Acronym / sponsor ID
- PUR / STU00210382
- Conditions
- Urinary Retention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated prematurely due to challenges with recruitment and feasibility of continuing the study
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 27 Feb 2022 (actual)
- Study completion
- 27 Feb 2022 (actual)
- First posted
- 5 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.
A study aimed at characterizing the comparing duration of catheterization for treatment of postpartum urinary retention (PUR) and characterizing short and long-term pelvic floor symptoms in women who have PUR.
Detailed description
The purpose of the study is to compare clinical outcomes of women with bladder distension injuries due to postpartum urinary retention (PUR) who have varying duration of catheterization for initial treatment of postpartum urinary retention.
Hypotheses
- Longer duration of therapeutic catheterization will be associated with resolution of postpartum voiding dysfunction in women who sustain severe bladder distension injuries due to postpartum urinary retention. Definition of resolution of postpartum voiding dysfunction:
- A post void residual volume of less than half of initial instilled volume on the first retrograde voiding trial, AND B. No need for re-treatment for urinary retention within 1 week
- The incidence of postpartum urinary retention (PUR) will vary by route of delivery, with operative vaginal delivery having the highest incidence.
- Risk factors for PUR will be related to intrapartum and delivery conditions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In Arm 2, women with severe postpartum urinary retention will be randomized to 3 or 7 days of foley catheter.
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 (NonSevere PUR and women without PUR) | No intervention | –Women in GROUP 1 will be prospectively observed to characterize their clinical outcomes. |
| GROUP 2 (Severe PUR) | Experimental | Other: Duration of Indwelling CatheterWomen in GROUP 2 will be a randomized to either 3 or 7 days of indwelling catheterization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than or equal to 18.
- Vaginal or cesarean delivery at term (37 weeks gestational age or later) of live-born infants.
- English or Spanish speaking and reading.
Key exclusion criteria (10 listed)
- Adults unable to consent.
- Women under the age of 18.
- Women who are currently pregnant (All women in the study will have already delivered).
- Prisoners or detained individuals.
- Women who chronically use a urinary catheter for another medical condition.
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 |
|---|---|---|
| Duration of Indwelling CatheterFoley catheter | Other | GROUP 2 (Severe PUR) |
Primary outcome
To evaluate whether 3 days of indwelling catheterization is inferior to 7 days in resolving postpartum urinary retention.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Study was terminated prematurely due to challenges with recruitment and feasibility of continuing the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Urinary Retention
Not yet recruiting
Effect of Voiding Position (Standing in the Shower vs. Sitting) on Post- Void Residual Urine Volume (PVR) After Removal of Urinary Catheter in Women Following Vaginal Delivery With Epidural Analgesia: A Double- Blind Randomized Controlled Trial
Postpartum Urinary Retention
Recruiting
Pelvic Health Electrically Evoked Recording (PEER) 2 Study
Overactive Bladder, Fecal Incontinence
Not yet recruitingObservational study
Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction
Overactive Bladder (OAB), Urgency Urinary Incontinence
Recruiting
Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate
BPH With Symptomatic Lower Urinary Tract Symptoms, BPH With Urinary Obstruction
Active, not recruiting
Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia With Outflow Obstruction, Urinary Retention
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.
Sarah Collins, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duration of Indwelling Catheter in people with Urinary Retention, run by Northwestern University 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 10 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 20 Apr 2022. 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 was stopped early (reason given: Study was terminated prematurely due to challenges with recruitment and feasibility of continuing the 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?
To evaluate whether 3 days of indwelling catheterization is inferior to 7 days in resolving postpartum urinary retention. (time frame: 1 year). 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 20 Apr 2022.