Pelvic Organ ProlapseNCT01525498
Foley Catheterization Following Sacrocolpopexy
An observational study of Pelvic Organ Prolapse and Catheter Infection, run by University of Oklahoma at 1 site in United States.
Trial summary
The objective of this study is to prospectively evaluate the effects of early versus delayed removal of transuretheral catheters following sacrocolpopexy. The investigators specific aim is to determine the optimal time of removal of an indwelling transurethral catheter postoperatively in an effort to reduce the risk… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Catheter Infection, Urinary Retention
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Apr 2013
- Phase
- Observational
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The projected sample size is 584 participants. Participants will be drawn from the University of Oklahoma Urogynecology clinics. Our catchment area includes OU Physicians clinic (private clinic) and Presbyterian Professional Building (resident clinic).
Who may be able to join
- Age at least 21
- Scheduled to undergo sacrocolpopexy at the University of Oklahoma Health Sciences Center
Who cannot join
- Age < 21
- Elevated postvoid residual measurement on preoperative exam
- History of urinary retention
- Medical or surgical indication for prolonged catheterization
- History of neurologic problems
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Urinary Bladder Catheterization Following Sacrocolpopexy
The objective of this study is to prospectively evaluate the effects of early versus delayed removal of transuretheral catheters following sacrocolpopexy. The investigators specific aim is to determine the optimal time of removal of an indwelling transurethral catheter postoperatively in an effort to reduce the risk of postoperative urinary retention and urinary tract infection associated with catheter use. The investigators hypotheses are as follows:
Hypothesis 1: Longer duration of postoperative catheter use will result in decreased postoperative urinary retention.
Hypothesis 2: Shorter duration of postoperative catheter use will result in lower incidence of urinary tract infection.
Read the detailed description
Patients scheduled to undergo sacrocolpopexy for pelvic organ prolapse at the University of Oklahoma Health Sciences Center will be recruited for this study. Written informed consent will be obtained from all participants prior to the scheduled surgery and before the randomization process. This study will contain two arms, each with two groups. The first arm will have participants receiving sacrocolpopexy for pelvic organ prolapse; the second arm will consist of participants receiving sacrocolpopexy plus a concomitant procedure for stress urinary incontinence. Each participant will be assigned to the arm that matches their scheduled procedure; they will then be randomized into one of the two study groups within that arm. Randomization will be performed by placing note cards in sealed envelopes with "Group A" or "Group B" listed on the card. One envelope will be placed with each participant's preoperative packet and opened on the day of surgery after the operation is complete.On the date of the procedure, a urinalysis will be performed prior to the routine administration of prophylactic antibiotics. At the beginning of the procedure, a transurethral catheter will be placed as is routine for this procedure. At the conclusion of the procedure, the sealed envelope containing the participant's group designation will be opened and she will be assigned to one of two groups. Group A participants will have their catheter removed on postoperative day 1 and Group B will have their catheter removed on postoperative day 2.
- Conditions
- Pelvic Organ Prolapse, Catheter Infection, Urinary Retention
- Keywords
- Pelvic Organ Prolapse, Catheterization, Urinary tract infection, Urinary retention
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Retention, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 day catheter removal | Participants randomized to group 1 will have their catheter removed 1 day after surgery. | |
| 2 day catheter removal | Participants randomized to group 2 will have their catheter removed 2 days after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary retention following catheter removal
Measured: 2 days
need for repeat catheterization
Measured: 2 days
Presence of bacteriuria at catheter removal
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startAug 2011
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: No subject accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abbas Shobeiri, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525498
- Sponsor's protocol ID
- Foley
- Status last verified
- Oct 2013
- First submitted
- 19 Jan 2012
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Bladder Catheterization Following Sacrocolpopexy
- ClinicalTrials.gov ID
- NCT01525498
- Acronym / sponsor ID
- Foley
- Conditions
- Pelvic Organ Prolapse, Catheter Infection, Urinary Retention
- Keywords
- Pelvic Organ Prolapse, Catheterization, Urinary tract infection, Urinary retention
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No subject accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Feb 2012 (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.
The objective of this study is to prospectively evaluate the effects of early versus delayed removal of transuretheral catheters following sacrocolpopexy. The investigators specific aim is to determine the optimal time of removal of an indwelling transurethral catheter postoperatively in an effort to reduce the risk of postoperative urinary retention and urinary tract infection associated with catheter use. The investigators hypotheses are as follows:
Hypothesis 1: Longer duration of postoperative catheter use will result in decreased postoperative urinary retention.
Hypothesis 2: Shorter duration of postoperative catheter use will result in lower incidence of urinary tract infection.
Detailed description
Patients scheduled to undergo sacrocolpopexy for pelvic organ prolapse at the University of Oklahoma Health Sciences Center will be recruited for this study. Written informed consent will be obtained from all participants prior to the scheduled surgery and before the randomization process. This study will contain two arms, each with two groups. The first arm will have participants receiving sacrocolpopexy for pelvic organ prolapse; the second arm will consist of participants receiving sacrocolpopexy plus a concomitant procedure for stress urinary incontinence. Each participant will be assigned to the arm that matches their scheduled procedure; they will then be randomized into one of the two study groups within that arm. Randomization will be performed by placing note cards in sealed envelopes with "Group A" or "Group B" listed on the card. One envelope will be placed with each participant's preoperative packet and opened on the day of surgery after the operation is complete.On the date of the procedure, a urinalysis will be performed prior to the routine administration of prophylactic antibiotics. At the beginning of the procedure, a transurethral catheter will be placed as is routine for this procedure. At the conclusion of the procedure, the sealed envelope containing the participant's group designation will be opened and she will be assigned to one of two groups. Group A participants will have their catheter removed on postoperative day 1 and Group B will have their catheter removed on postoperative day 2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 day catheter removal | – | –Participants randomized to group 1 will have their catheter removed 1 day after surgery. |
| 2 day catheter removal | – | –Participants randomized to group 2 will have their catheter removed 2 days after surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The projected sample size is 584 participants. Participants will be drawn from the University of Oklahoma Urogynecology clinics. Our catchment area includes OU Physicians clinic (private clinic) and Presbyterian Professional Building (resident clinic).
Key inclusion criteria (2 listed)
- Age at least 21
- Scheduled to undergo sacrocolpopexy at the University of Oklahoma Health Sciences Center
Key exclusion criteria (5 listed)
- Age < 21
- Elevated postvoid residual measurement on preoperative exam
- History of urinary retention
- Medical or surgical indication for prolonged catheterization
- History of neurologic problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urinary retention following catheter removal
Time frame: 2 days
need for repeat catheterization
Time frame: 2 days
Presence of bacteriuria at catheter removal
Time frame: 2 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
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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.
Abbas Shobeiri, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse and Catheter Infection, run by University of Oklahoma 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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 16 Oct 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Urinary retention following catheter removal (time frame: 2 days). The study lists 3 primary outcomes in all. 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 16 Oct 2013.