Stress Urinary IncontinenceURINE&MENCT01583166

Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial

A study testing Bupivacaine, Saline and Epinephrine in people with Stress Urinary Incontinence, run by University of Massachusetts, Worcester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if there is a difference in post-operative voiding function between subjects receiving local anesthetic and those receiving placebo at the time of mid-urethral sling placement. The secondary objective is to evaluate pain after the procedure in the two groups. 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?: Bupivacaine, Saline and Epinephrine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 1 siteUnited States
Study dates: Mar 2012to May 2016
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

Scheduled to undergo mid-urethral sling for incontinence without concomitant procedures

Who cannot join

Undergoing procedure in addition to the sling
Not competent to give consent
Using intermittent self catheterization pre-operatively
Known allergy to local anesthetic
Undergoing spinal anesthesia for the procedure
Prisoners

Show all 9Show fewer

Non-English speaker
Under 18 years of age
Has a condition that would contra-indicate the use of local anesthetic or epinephrine

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Massachusetts
Worcester, Massachusetts, 01655

Other trials in United States

About this study

Conditions: Stress Urinary Incontinence
Being tested: Bupivacaine, Saline, Epinephrine
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.

BupivacaineDrug
Also called Marcaine
10ml 0.5% bupivacaine
SalineDrug
Also called Sodium Chloride
10ml 0.9% sodium chloride
EpinephrineDrug
1:200,000 epinephrine

Study groups in NCT01583166
Study group	Role	What they receive
Bupivacaine + epinephrine	Active comparator	Not described Receives: Drug: Bupivacaine; Drug: Epinephrine
Saline + epinephrine	Placebo comparator	Not described Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling
Study team assessment of whether the use of local anesthetic has any affect on the percentage of patients who pass their post-operative bladder challenge. This is determined by their voided volume and post-void residual.
Measured: 2 weeks

Secondary outcomes (3)

Post-operative Pain Scores at 2-3 Hours Post op
Visual analog score at 2 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain)
Measured: 2-3 hours
Post-operative Pain Scale at 6-7 Hours Post op
Visual analog score at 6 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain)
Measured: 6-7 hours
Visual Analog Scale for Pain: Pre-operative.
Participants asked to report on pre-operative level of pain using a Visual Analog Scale. The scale is participant reported and ranges from 0 representing no pain to 10 representing unbearable pain.
Measured: At enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012May 2016

First posted23 Apr 2012 (estimated)
Study startMar 2012
Primary completionMay 2016
Study completionMay 2016

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.
Publications (1)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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01583166
Sponsor's protocol ID: 14197
Acronym: URINE&ME
Status last verified: Oct 2018
First submitted: 19 Apr 2012
Last updated: 28 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Duenas-Garcia OF, Patterson D, De la Luz Nieto M, Leung K, Flynn MK. Voiding Function After Midurethral Slings With and Without Local Anesthetic: Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2017 Jan/Feb;23(1):56-60. doi: 10.1097/SPV.0000000000000343.
PubMed 27682748

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Stress Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial
ClinicalTrials.gov ID: NCT01583166
Acronym / sponsor ID: URINE&ME / 14197
Conditions: Stress Urinary Incontinence
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: University of Massachusetts, WorcesterUniversity, hospital or other
Study start: Mar 2012
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 23 Apr 2012 (estimated)
Results: Posted 28 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Bupivacaine + epinephrine	Active comparator	Drug: Bupivacaine, Drug: Epinephrine
Saline + epinephrine	Placebo comparator	Drug: Saline

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)

Scheduled to undergo mid-urethral sling for incontinence without concomitant procedures

Key exclusion criteria (9 listed)

Undergoing procedure in addition to the sling
Not competent to give consent
Using intermittent self catheterization pre-operatively
Known allergy to local anesthetic
Undergoing spinal anesthesia for the procedure

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
BupivacaineAlso: Marcaine10ml 0.5% bupivacaine	Drug	Bupivacaine + epinephrine
SalineAlso: Sodium Chloride10ml 0.9% sodium chloride	Drug	Saline + epinephrine
Epinephrine1:200,000 epinephrine	Drug	Bupivacaine + epinephrine

Primary outcome

Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling
Time frame: 2 weeks
Study team assessment of whether the use of local anesthetic has any affect on the percentage of patients who pass their post-operative bladder challenge. This is determined by their voided volume and post-void residual.

3 secondary outcomes

Post-operative Pain Scores at 2-3 Hours Post op
Time frame: 2-3 hours
Post-operative Pain Scale at 6-7 Hours Post op
Time frame: 6-7 hours
Visual Analog Scale for Pain: Pre-operative.
Time frame: At enrollment

Results and safety

Results posted to the registry on 28 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Marcaine + Epinephrine	45	41
Saline + Epinephrine	45	39

Primary outcome: Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling

Time frame: 2 weeks. Count of participants. Unit: Participants

Measure	Marcaine + Epinephrine n = 41	Saline + Epinephrine n = 39
Value	31	32

Population analysed: Passed void trial

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Marcaine + Epinephrine	0 of 45 (0%)	0 of 45 (0%)	0 of 45
Saline + Epinephrine	0 of 45 (0%)	0 of 45 (0%)	0 of 45

Limitations and caveats (from the sponsor): Failure to obtain 6-7 hour pain score for 24/80 participants. Impact of large preponderance of slings placed by a subrapublic approach. Study not designed to examine the effect of phenazopyridine in study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27682748Duenas-Garcia OF, Patterson D, De la Luz Nieto M, Leung K, Flynn MK. Voiding Function After Midurethral Slings With and Without Local Anesthetic: Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2017 Jan/Feb;23(1):56-60. doi: 10.1097/SPV.0000000000000343.

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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bupivacaine, Saline and Epinephrine in people with Stress Urinary Incontinence, run by University of Massachusetts, Worcester 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 1 inclusion and 9 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 28 Nov 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. Some participants in this study may receive a placebo. 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 28 Nov 2018). 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?

Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling (time frame: 2 weeks). 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 NCT01583166, which also lists 1 linked publication.

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 28 Nov 2018; AzTrials last refreshed its copy on 27 Oct 2026.