Postoperative BacteriuriaNCT01926756
Does Straight Catheterization in Short Gynecologic Procedures Cause Bacteriuria?
A study testing Straight catheterization and No straight catheterization in people with Postoperative Bacteriuria, run by Abington Memorial Hospital at 1 site in United States.
Trial summary
This is a prospective randomized controlled trial to look into the reduction of catheter associated urinary tract infections in the postoperative period. It will specifically look at short gynecologic procedures such as D\&C (dilation and curettage), hysteroscopies and LEEP procedures and the need to perform… 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
- Postoperative Bacteriuria
- What is being tested?
- Straight catheterization and No straight catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2014
- 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
- The patient must be 18 years of age or older.
- The patient must be female.
- The patient must be undergoing a same-day gynecologic procedure where catheterization is usually performed.
- The patient must have general anesthesia or monitored anesthesia care (MAC). This includes IV sedation.
Who cannot join
- The patient cannot be undergoing intermittent one-time catheterization.
- The patient can not have had an indwelling catheter placed in the past 6 months.
- The patients cannot have a concomitant pelvic infection.
- The procedure cannot require spinal anesthesia.
- The patient cannot be taking immunosuppressive medications.
- The patient cannot be taking antibiotics and/or suppressive therapy for chronic urinary tract infections.
- The patient cannot receive pre-operative or intra-operative antibiotics.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Emily Parent, D.O., 215-481-7663, eparent@amh.org
Joel Polin, M.D., 215-481-4211, JPolin@amh.org
About this study
Official title: Intraoperative One-Time Catheterization in Short Gynecologic Procedures and Its Potential Effect on Symptomatic and Asymptomatic Bacteriuria
This is a prospective randomized controlled trial to look into the reduction of catheter associated urinary tract infections in the postoperative period. It will specifically look at short gynecologic procedures such as D\&C (dilation and curettage), hysteroscopies and LEEP procedures and the need to perform intraoperative catheterization. If a patient urinates immediately before a short operation then there is no need to drain the bladder with a catheter during the procedure. The investigators hypothesize that eliminating catheterization during these short procedures may decrease postoperative urinary tract infections. The hope is that this study would provide evidence to support a change in practice.
Read the detailed description
The majority of research currently concentrates on indwelling catheters rather than one-time catheterization. Current practice at our institution in the gynecologic operating room is to perform a one time catheterization on patient's undergoing short procedures, yet it is unclear if this is a necessary intervention. If patients are asked to void immediately before their procedure it would eliminate the need for intra-operative catheterization and eliminate a potential source of infection.
The study is designed to determine whether routine catheterization prior to a minor OB/GYN procedure causes symptomatic or asymptomatic bacteria in the urine. Current practice is one-time catheterization of patients undergoing minor OB/GYN procedures prior to the beginning of the procedure. The investigators hypothesize that this causes asymptomatic or symptomatic bacteriuria.
- Conditions
- Postoperative Bacteriuria
- Being tested
- Straight catheterization, No straight catheterization
- Keywords
- bacteriuria, straight catheterization, urinary tract infections, iatrogenic
- Medical subject headings
- Bacteriuria, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straight catheterizationProcedure or surgery
Patient will receive the current standard practice of straight catheterization intraoperatively.
No straight catheterizationProcedure or surgery
Patients will not be catheterized which is an experimental change from the current practice at our hospital.
| Study group | Role | What they receive |
|---|---|---|
| Straight catheterization (control) | Other | The control arm is the current practice at our hospital (to perform straight catheterization for short procedures). Receives: Procedure: Straight catheterization |
| No straight catheterization | Active comparator | The experimental arm will void preoperatively and will not be straight catheterized intraoperatively. This is a change from the current practice at our hospital. Receives: Procedure: No straight catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Bacteriuria
Urine cultures are obtained preoperatively (baseline), immediately postoperatively and 2 to 4 weeks postoperatively.
Measured: 2 -4 weeks
Secondary outcomes (1)
Subjective urinary tract discomfort
Measured: 2-4 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative BacteriuriaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abington Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily G. Parent, D.O., Abington Memorial Hospital
- Investigators
- Emily G Parent, D.O., Principal investigator, Abington Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926756
- Sponsor's protocol ID
- AMH-Myers/Parent001
- Status last verified
- Aug 2013
- First submitted
- 19 Aug 2013
- Last updated
- 21 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative One-Time Catheterization in Short Gynecologic Procedures and Its Potential Effect on Symptomatic and Asymptomatic Bacteriuria
- ClinicalTrials.gov ID
- NCT01926756
- Acronym / sponsor ID
- AMH-Myers/Parent001
- Conditions
- Postoperative Bacteriuria
- Keywords
- bacteriuria, straight catheterization, urinary tract infections, iatrogenic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Abington Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (estimated)
- First posted
- 21 Aug 2013 (estimated)
- 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.
This is a prospective randomized controlled trial to look into the reduction of catheter associated urinary tract infections in the postoperative period. It will specifically look at short gynecologic procedures such as D\&C (dilation and curettage), hysteroscopies and LEEP procedures and the need to perform intraoperative catheterization. If a patient urinates immediately before a short operation then there is no need to drain the bladder with a catheter during the procedure. The investigators hypothesize that eliminating catheterization during these short procedures may decrease postoperative urinary tract infections. The hope is that this study would provide evidence to support a change in practice.
Detailed description
The majority of research currently concentrates on indwelling catheters rather than one-time catheterization. Current practice at our institution in the gynecologic operating room is to perform a one time catheterization on patient's undergoing short procedures, yet it is unclear if this is a necessary intervention. If patients are asked to void immediately before their procedure it would eliminate the need for intra-operative catheterization and eliminate a potential source of infection.
The study is designed to determine whether routine catheterization prior to a minor OB/GYN procedure causes symptomatic or asymptomatic bacteria in the urine. Current practice is one-time catheterization of patients undergoing minor OB/GYN procedures prior to the beginning of the procedure. The investigators hypothesize that this causes asymptomatic or symptomatic bacteriuria.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Straight catheterization (control) | Other | Procedure: Straight catheterizationThe control arm is the current practice at our hospital (to perform straight catheterization for short procedures). |
| No straight catheterization | Active comparator | Procedure: No straight catheterizationThe experimental arm will void preoperatively and will not be straight catheterized intraoperatively. This is a change from the current practice at our hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must be 18 years of age or older.
- The patient must be female.
- The patient must be undergoing a same-day gynecologic procedure where catheterization is usually performed.
- The patient must have general anesthesia or monitored anesthesia care (MAC). This includes IV sedation.
Key exclusion criteria (7 listed)
- The patient cannot be undergoing intermittent one-time catheterization.
- The patient can not have had an indwelling catheter placed in the past 6 months.
- The patients cannot have a concomitant pelvic infection.
- The procedure cannot require spinal anesthesia.
- The patient cannot be taking immunosuppressive medications.
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 |
|---|---|---|
| Straight catheterizationPatient will receive the current standard practice of straight catheterization intraoperatively. | Procedure or surgery | Straight catheterization (control) |
| No straight catheterizationPatients will not be catheterized which is an experimental change from the current practice at our hospital. | Procedure or surgery | No straight catheterization |
Primary outcome
Postoperative Bacteriuria
Time frame: 2 -4 weeks
Urine cultures are obtained preoperatively (baseline), immediately postoperatively and 2 to 4 weeks postoperatively.
1 secondary outcome
Subjective urinary tract discomfort
Time frame: 2-4 weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
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.
Emily G Parent, D.O. principal investigator
Abington Memorial 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 Straight catheterization and No straight catheterization in people with Postoperative Bacteriuria, run by Abington Memorial Hospital 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 4 inclusion and 7 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 21 Aug 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emily G Parent, D.O. (215-481-7663, eparent@amh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Bacteriuria (time frame: 2 -4 weeks). 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 21 Aug 2013.