Bladder DysfunctionNCT01460303
Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter
A study testing Transurethral catheter with leg bag in people with Bladder Dysfunction and Urinary Retention, run by University of Massachusetts, Worcester.
Trial summary
Following surgery for female urinary incontinence and/or pelvic organ prolapse, women are sometimes temporarily unable to empty their bladders and are sent home with a transurethral indwelling catheter attached to a bag which holds urine. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bladder Dysfunction, Urinary Retention
- What is being tested?
- Transurethral catheter with leg bag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing surgery for urinary incontinence and/or pelvic organ prolapse at the UMass Memorial Medical Center with one of the Urogynecology/Reconstructive Pelvic Surgery faculty.
Who cannot join
- inability to provide consent
- <18 years old
- non-English speaking
- patients using intermittent self-catheterization
- patients sustaining bladder injury during surgery
- prisoners
- pregnant women
About this study
Official title: Clinical Trial of Patient Operated Valved Catheter Compared With Standard Indwelling Transurethral Catheter for Postoperative Bladder Management
Following surgery for female urinary incontinence and/or pelvic organ prolapse, women are sometimes temporarily unable to empty their bladders and are sent home with a transurethral indwelling catheter attached to a bag which holds urine. The goal of this study is to compare a new type of patient-operated catheter without a bag to the catheter with a bag for ease of use, comfort and quality of life for patients during the postoperative recovery period. This new catheter, the OPTION-vf, is approved by the FDA and is available on the market.
- Conditions
- Bladder Dysfunction, Urinary Retention
- Being tested
- Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag, Transurethral catheter with leg bag
- Keywords
- Transurethral catheterization, Urinary retention, Bladder dysfunction, Patient comfort, Pelvic Reconstructive Surgery, Postoperative bladder dysfunction, Postoperative urinary retention
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bagDevice
Also called OPTION-vf™ Valved Female Urinary Catheter, Patient Controlled Catheter
OPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered "passed" when a patient is able to void adequately and spontaneously (without the assistance of a catheter).
Transurethral catheter with leg bagDevice
Also called Foley catheter
Transurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered "passed" when a patient is able to void adequately and spontaneously (without the assistance of a catheter).
| Study group | Role | What they receive |
|---|---|---|
| OPTION-vf patient controlled catheter | Experimental | Patients who fail postop bladder challenge and are randomized to "OPTION-vf" arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge. Receives: Device: Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag |
| Transurethral catheter w/leg bag | Active comparator | Patients who fail postop bladder challenge and are randomized to "indwelling catheter with leg bag" arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge. Receives: Device: Transurethral catheter with leg bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Catheter Related Pain
Total Catheter Related Pain Range Scale (0 = none, to 10 = worst) on the Post Operative Questionnaire All subjects were given and appointment for an outpatient voiding trial after hospital discharge. The Post Operative questionnaire was completed by the subject one time at that appointment.
Measured: 5-10 days postoperatively
Secondary outcomes (1)
Composite Satisfaction Score (CSS)
The mean scores for the first 5 questions of the Post Operative Questionnaire were used to calculate a Composite Satisfaction Score.
- Total Pain (0 none, 10 worst)
- Total Catheter Related Pain Range Scale (0 none, 10 worst)
- Ease of catheter use (0 easy, 10 difficult)
- Feeling of frustration (0 none, 10 very much)
- Limited social activities (0 none, 10 very much) All subjects were given and appointment for an outpatient voiding trial after hospital discharge. The Post Operative Questionnaire was completed by the subject one time at that appointment.
Measured: 5-10 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder DysfunctionStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Flynn, University of Massachusetts, Worcester
- Investigators
- Michael Flynn, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460303
- Sponsor's protocol ID
- H-13523
- Status last verified
- May 2018
- First submitted
- 19 Oct 2011
- Last updated
- 4 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Patient Operated Valved Catheter Compared With Standard Indwelling Transurethral Catheter for Postoperative Bladder Management
- ClinicalTrials.gov ID
- NCT01460303
- Acronym / sponsor ID
- H-13523
- Conditions
- Bladder Dysfunction, Urinary Retention
- Keywords
- Transurethral catheterization, Urinary retention, Bladder dysfunction, Patient comfort, Pelvic Reconstructive Surgery, Postoperative bladder dysfunction, Postoperative urinary retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Oct 2011 (estimated)
- Results
- Posted 5 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Following surgery for female urinary incontinence and/or pelvic organ prolapse, women are sometimes temporarily unable to empty their bladders and are sent home with a transurethral indwelling catheter attached to a bag which holds urine. The goal of this study is to compare a new type of patient-operated catheter without a bag to the catheter with a bag for ease of use, comfort and quality of life for patients during the postoperative recovery period. This new catheter, the OPTION-vf, is approved by the FDA and is available on the market.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPTION-vf patient controlled catheter | Experimental | Device: Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bagPatients who fail postop bladder challenge and are randomized to "OPTION-vf" arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge. |
| Transurethral catheter w/leg bag | Active comparator | Device: Transurethral catheter with leg bagPatients who fail postop bladder challenge and are randomized to "indwelling catheter with leg bag" arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing surgery for urinary incontinence and/or pelvic organ prolapse at the UMass Memorial Medical Center with one of the Urogynecology/Reconstructive Pelvic Surgery faculty.
Key exclusion criteria (7 listed)
- inability to provide consent
- <18 years old
- non-English speaking
- patients using intermittent self-catheterization
- patients sustaining bladder injury during surgery
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 |
|---|---|---|
| Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bagAlso: OPTION-vf™ Valved Female Urinary Catheter, Patient Controlled CatheterOPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered "passed" when a patient is able to void adequately and spontaneously (without the assistance of a catheter). | Device | OPTION-vf patient controlled catheter |
| Transurethral catheter with leg bagAlso: Foley catheterTransurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered "passed" when a patient is able to void adequately and spontaneously (without the assistance of a catheter). | Device | Transurethral catheter w/leg bag |
Primary outcome
Total Catheter Related Pain
Time frame: 5-10 days postoperatively
Total Catheter Related Pain Range Scale (0 = none, to 10 = worst) on the Post Operative Questionnaire All subjects were given and appointment for an outpatient voiding trial after hospital discharge. The Post Operative questionnaire was completed by the subject one time at that appointment.
1 secondary outcome
Composite Satisfaction Score (CSS)
Time frame: 5-10 days postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael Flynn, MD principal investigator
University of Massachusetts, Worcester
Questions about this trial
What is this clinical trial studying?
A study testing Transurethral catheter with leg bag in people with Bladder Dysfunction and Urinary Retention, run by University of Massachusetts, Worcester.
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 1 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: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 5 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Catheter Related Pain (time frame: 5-10 days postoperatively). 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 4 May 2018.