Stress Urinary IncontinenceNCT02277288
Does Bladder Instillation Reduce Time to Discharge After Sling Surgery
A study testing Filled bladder arm in people with Stress Urinary Incontinence, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this randomized control trial study is to determine if intraoperative bladder instillation of fluid decreases the time to discharge after having an outpatient mid-urethral sling procedure, and to measure the cost savings of this decrease in hospital stay. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Filled bladder arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age 18 years or older
- History of stress urinary incontinence
- Scheduled for outpatient mid-urethral sling procedure, any approach
Who cannot join
- Age less than 18 years
- Pregnancy
- Inability to give informed consent
- History of urinary retention
Trial locations and contacts
1 site in 1 country.
Jennifer Anger, MD, MPH contact
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Beverly Hills, California, 90211
Jennifer Anger, MD, MPH, 310-385-2992
Jennifer Anger, MD, MPH
About this study
Official title: Does Intraoperative Bladder Instillation Decrease Outpatient Recovery Time After Mid-Urethral Sling
The purpose of this randomized control trial study is to determine if intraoperative bladder instillation of fluid decreases the time to discharge after having an outpatient mid-urethral sling procedure, and to measure the cost savings of this decrease in hospital stay. Charges will be broken down between recovery room charges and discharge area, as recovery room charges are significantly higher. The investigators suspect that a shorter time in the recovery room will translate into fewer charges.
Read the detailed description
Urinary stress incontinence affects 4-35% of women. Due to the large economic impact and prevalence of the disease, urinary incontinence is a significant public health issue. With rising healthcare costs it has become increasingly important to manage patient care in the most cost-efficient manner. Considering the increasing number of women undergoing mid-urethral sling procedures, it is imperative that perioperative care is streamlined in order to minimize cost. The Cedars-Sinai Center for Continence and Women's Pelvic Health instituted a new practice pattern that enables patients to complete a voiding trial sooner after surgery compared to previous practice patterns thus allowing patients to be discharged earlier and ultimately decreasing cost. The purpose of this study is to compare the previous voiding trial practice (emptying the bladder at the end of surgery) versus the newly instituted practice (filling with bladder with 250cc) and perform a cost benefit analysis to determine if there is a significant decrease in recovery and discharge time. Both of these practices fall under the standard-of-care. However, of the several standard-of-care procedures, none have been tested for superiority. To date there are no randomized control trials that address this issue in female mid-urethral sling surgery.
Boccola et al showed in a study of 60 men who had undergone transurethral resection of the prostate (TURP) that by instilling the bladder with 300-500cc of warm saline the time to void was significantly decreased compared to standard indwelling catheter removal. It was also shown that the bladder instillation group had a significantly shorter time to discharge. The study suggested that given the significant decrease in time in recovery, this would be an ideal practice for many other outpatient procedures. Willson, et al, in another randomized trial of 75 men who underwent TURP, found that bladder infusion allowed early decision-making for discharge on the second postoperative day. Finally, McAchran and Goldman found that when patients were managed using a fast-track regimen in the outpatient setting after mid-urethral sling procedures the median time from the recovery area to discharge was less than 3 hours.
For our study, if a significant decrease in the time to discharge with the newly instituted practice pattern is demonstrated, then this practice can be adopted by other institutions and become the new standard of care to help decrease both cost and patient time in the hospital.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Filled bladder arm
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filled bladder armOther
Bladder to be instilled with 200 cc fluid during cystoscopy and no catheter for all mid-urethral sling procedures.
| Study group | Role | What they receive |
|---|---|---|
| Emptied bladder arm | No intervention | No instillation of fluid into bladder. |
| Filled bladder arm | Experimental | Instilled bladder with fluid. Receives: Other: Filled bladder arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time between surgery and discharge home
Will analyze if the time to discharge is shorter in those patients who have had bladder instillation versus those with an indwelling catheter postoperatively.
Measured: 2 Days
Secondary outcomes (1)
Hospital charges
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startDec 2011
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer T. Anger, Cedars-Sinai Medical Center
- Investigators
- Jennifer Anger, MD, MPH, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277288
- Sponsor's protocol ID
- Pro00026292
- Status last verified
- Jul 2018
- First submitted
- 16 Oct 2014
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boccola MA, Sharma A, Taylor C, Wong LM, Travis D, Chan S. The infusion method trial of void vs standard catheter removal in the outpatient setting: a prospective randomized trial. BJU Int. 2011 Apr;107 Suppl 3:43-6. doi: 10.1111/j.1464-410X.2011.10044.x.
PubMed 21492377Wilson ID, Bramwell SP, Hollins GW. A randomized trial comparing bladder infusion with standard catheter removal after transurethral resection of the prostate. BJU Int. 2000 Dec;86(9):993-5. doi: 10.1046/j.1464-410x.2000.00963.x.
PubMed 11119091McAchran SE, Goldman HB. Contemporary length of stay and resource utilization when using a fast-track regimen for mid-urethral sling surgery. Urology. 2009 Sep;74(3):531-4. doi: 10.1016/j.urology.2009.04.039. Epub 2009 Jul 9.
PubMed 19592077Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S3-9.
PubMed 16985863Wilson L, Brown JS, Shin GP, Luc KO, Subak LL. Annual direct cost of urinary incontinence. Obstet Gynecol. 2001 Sep;98(3):398-406. doi: 10.1016/s0029-7844(01)01464-8.
PubMed 11530119
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intraoperative Bladder Instillation Decrease Outpatient Recovery Time After Mid-Urethral Sling
- ClinicalTrials.gov ID
- NCT02277288
- Acronym / sponsor ID
- Pro00026292
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Oct 2014 (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 purpose of this randomized control trial study is to determine if intraoperative bladder instillation of fluid decreases the time to discharge after having an outpatient mid-urethral sling procedure, and to measure the cost savings of this decrease in hospital stay. Charges will be broken down between recovery room charges and discharge area, as recovery room charges are significantly higher. The investigators suspect that a shorter time in the recovery room will translate into fewer charges.
Detailed description
Urinary stress incontinence affects 4-35% of women. Due to the large economic impact and prevalence of the disease, urinary incontinence is a significant public health issue. With rising healthcare costs it has become increasingly important to manage patient care in the most cost-efficient manner. Considering the increasing number of women undergoing mid-urethral sling procedures, it is imperative that perioperative care is streamlined in order to minimize cost. The Cedars-Sinai Center for Continence and Women's Pelvic Health instituted a new practice pattern that enables patients to complete a voiding trial sooner after surgery compared to previous practice patterns thus allowing patients to be discharged earlier and ultimately decreasing cost. The purpose of this study is to compare the previous voiding trial practice (emptying the bladder at the end of surgery) versus the newly instituted practice (filling with bladder with 250cc) and perform a cost benefit analysis to determine if there is a significant decrease in recovery and discharge time. Both of these practices fall under the standard-of-care. However, of the several standard-of-care procedures, none have been tested for superiority. To date there are no randomized control trials that address this issue in female mid-urethral sling surgery.
Boccola et al showed in a study of 60 men who had undergone transurethral resection of the prostate (TURP) that by instilling the bladder with 300-500cc of warm saline the time to void was significantly decreased compared to standard indwelling catheter removal. It was also shown that the bladder instillation group had a significantly shorter time to discharge. The study suggested that given the significant decrease in time in recovery, this would be an ideal practice for many other outpatient procedures. Willson, et al, in another randomized trial of 75 men who underwent TURP, found that bladder infusion allowed early decision-making for discharge on the second postoperative day. Finally, McAchran and Goldman found that when patients were managed using a fast-track regimen in the outpatient setting after mid-urethral sling procedures the median time from the recovery area to discharge was less than 3 hours.
For our study, if a significant decrease in the time to discharge with the newly instituted practice pattern is demonstrated, then this practice can be adopted by other institutions and become the new standard of care to help decrease both cost and patient time in the hospital.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emptied bladder arm | No intervention | –No instillation of fluid into bladder. |
| Filled bladder arm | Experimental | Other: Filled bladder armInstilled bladder with fluid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Age 18 years or older
- History of stress urinary incontinence
- Scheduled for outpatient mid-urethral sling procedure, any approach
Key exclusion criteria (4 listed)
- Age less than 18 years
- Pregnancy
- Inability to give informed consent
- History of urinary retention
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 |
|---|---|---|
| Filled bladder armBladder to be instilled with 200 cc fluid during cystoscopy and no catheter for all mid-urethral sling procedures. | Other | Filled bladder arm |
Primary outcome
Time between surgery and discharge home
Time frame: 2 Days
Will analyze if the time to discharge is shorter in those patients who have had bladder instillation versus those with an indwelling catheter postoperatively.
1 secondary outcome
Hospital charges
Time frame: 1 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Background: PubMed 21492377Boccola MA, Sharma A, Taylor C, Wong LM, Travis D, Chan S. The infusion method trial of void vs standard catheter removal in the outpatient setting: a prospective randomized trial. BJU Int. 2011 Apr;107 Suppl 3:43-6. doi: 10.1111/j.1464-410X.2011.10044.x.
- Background: PubMed 11119091Wilson ID, Bramwell SP, Hollins GW. A randomized trial comparing bladder infusion with standard catheter removal after transurethral resection of the prostate. BJU Int. 2000 Dec;86(9):993-5. doi: 10.1046/j.1464-410x.2000.00963.x.
- Background: PubMed 19592077McAchran SE, Goldman HB. Contemporary length of stay and resource utilization when using a fast-track regimen for mid-urethral sling surgery. Urology. 2009 Sep;74(3):531-4. doi: 10.1016/j.urology.2009.04.039. Epub 2009 Jul 9.
- Background: PubMed 16985863Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S3-9.
- Background: PubMed 11530119Wilson L, Brown JS, Shin GP, Luc KO, Subak LL. Annual direct cost of urinary incontinence. Obstet Gynecol. 2001 Sep;98(3):398-406. doi: 10.1016/s0029-7844(01)01464-8.
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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.
Jennifer Anger, MD, MPH contact
Jennifer Anger, MD, MPH principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filled bladder arm in people with Stress Urinary Incontinence, run by Cedars-Sinai Medical Center 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 4 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 18 Jul 2018. 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 Jennifer Anger, MD, MPH (3103852992), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time between surgery and discharge home (time frame: 2 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02277288, which also lists 5 linked publications.
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 18 Jul 2018.