Stress Urinary IncontinencePhase 3NCT05702827
Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery
A Phase 3 study testing Bupivacaine-Meloxicam in people with Stress Urinary Incontinence and Surgical Incision, run by TriHealth Inc. at 2 sites in United States.
Trial summary
This study will compare the use of a dual-agent local analgesic (bupivacaine-meloxicam) for abdominal incisions in patients undergoing retropubic mid-urethral sling surgery to see if narcotic usage and pain are impacted. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Surgical Incision, Pain Vulva
- What is being tested?
- Bupivacaine-Meloxicam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jan 2023to 18 Apr 2024
- Phase
- Phase 3
- 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
- undergoing retropubic mid-urethral sling surgery (with concomitant anterior repair or urethrocele repair)
- English as first language
Who cannot join
- patients undergoing concomitant posterior repair, vaginal vault suspension, or any other intra-peritoneal surgeries including hysterectomy
- NSAID use within 7 days of surgery
- steroid use within 10 days
- daily opioid use in the last 3 months
- long acting opioids within 3 days
- any opioids within 24h
Show all 9Show fewer
- patients unable to consent for themselves
- patients allergic to meloxicam or bupivacaine
- pregnant or lactating patients
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati Urogynecology Associates
Cincinnati, Ohio, 45220
Trihealth (Good Samaritan Hospital, Bethesda North Hospital)
Cincinnati, Ohio, 45220
About this study
This study will compare the use of a dual-agent local analgesic (bupivacaine-meloxicam) for abdominal incisions in patients undergoing retropubic mid-urethral sling surgery to see if narcotic usage and pain are impacted.
- Conditions
- Stress Urinary Incontinence, Surgical Incision, Pain Vulva
- Being tested
- Bupivacaine-Meloxicam
- Medical subject headings
- Urinary Incontinence, Stress, Surgical Wound, Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-MeloxicamDrug
All patients will receive standard of care but the study arm will also receive Bupivacaine-Meloxicam in addition.
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine-meloxicam | Experimental | All patients will receive a total of 20 cc lidocaine with epinephrine injection intra-operatively along the trocar path via the suprapubic incisions, as is standard practice to help with hydrodissection for the procedure. 3-4 cc of bupivacaine-meloxicam will be infiltrated into each suprapubic abdominal incision in the study group Receives: Drug: Bupivacaine-Meloxicam |
| Standard of Care | No intervention | All patients will receive a total of 20 cc lidocaine with epinephrine injection intra-operatively along the trocar path via the suprapubic incisions, as is standard practice to help with hydrodissection for the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if use of bupivacaine-meloxicam reduces post-operative narcotic use over the first 3 days following surgery
Pain medication diary
Measured: 72 hours post surgery
Secondary outcomes (3)
Compare average pain on each day post operatively
11-point Numeric Rating Scale (NRS) for tracking pain using an illustrated figure to localize the pain, a 5-point Likert scale for satisfaction with pain control a Quality of Recovery (QoR-15) questionnaire filled out before surgery and on post-operative days 1 and 3
Measured: 72 hours post surgery
Compare worst pain on each day post operatively
11-point Numeric Rating Scale (NRS) for tracking pain using an illustrated figure to localize the pain, a 5-point Likert scale for satisfaction with pain control a Quality of Recovery (QoR-15) questionnaire filled out before surgery and on post-operative days 1 and 3
Measured: 72 hours post surgery
Compare satisfaction with pain control post operatively
11-point Numeric Rating Scale (NRS) for tracking pain using an illustrated figure to localize the pain, a 5-point Likert scale for satisfaction with pain control a Quality of Recovery (QoR-15) questionnaire filled out before surgery and on post-operative days 1 and 3
Measured: 72 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start23 Jan 2023
- Primary completion22 Mar 2024
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702827
- Sponsor's protocol ID
- 22-102
- Status last verified
- Nov 2024
- First submitted
- 18 Jan 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery
- ClinicalTrials.gov ID
- NCT05702827
- Acronym / sponsor ID
- 22-102
- Conditions
- Stress Urinary Incontinence, Surgical Incision, Pain Vulva
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 27 Jan 2023 (actual)
- 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 study will compare the use of a dual-agent local analgesic (bupivacaine-meloxicam) for abdominal incisions in patients undergoing retropubic mid-urethral sling surgery to see if narcotic usage and pain are impacted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupivacaine-meloxicam | Experimental | Drug: Bupivacaine-MeloxicamAll patients will receive a total of 20 cc lidocaine with epinephrine injection intra-operatively along the trocar path via the suprapubic incisions, as is standard practice to help with hydrodissection for the procedure. 3-4 cc of bupivacaine-meloxicam will be infiltrated into each suprapubic abdominal incision in the study group |
| Standard of Care | No intervention | –All patients will receive a total of 20 cc lidocaine with epinephrine injection intra-operatively along the trocar path via the suprapubic incisions, as is standard practice to help with hydrodissection for the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- undergoing retropubic mid-urethral sling surgery (with concomitant anterior repair or urethrocele repair)
- English as first language
Key exclusion criteria (9 listed)
- patients undergoing concomitant posterior repair, vaginal vault suspension, or any other intra-peritoneal surgeries including hysterectomy
- NSAID use within 7 days of surgery
- steroid use within 10 days
- daily opioid use in the last 3 months
- long acting opioids within 3 days
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 |
|---|---|---|
| Bupivacaine-MeloxicamAll patients will receive standard of care but the study arm will also receive Bupivacaine-Meloxicam in addition. | Drug | bupivacaine-meloxicam |
Primary outcome
To determine if use of bupivacaine-meloxicam reduces post-operative narcotic use over the first 3 days following surgery
Time frame: 72 hours post surgery
Pain medication diary
3 secondary outcomes
Compare average pain on each day post operatively
Time frame: 72 hours post surgery
Compare worst pain on each day post operatively
Time frame: 72 hours post surgery
Compare satisfaction with pain control post operatively
Time frame: 72 hours post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine-Meloxicam in people with Stress Urinary Incontinence and Surgical Incision, run by TriHealth Inc. at 2 sites 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 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 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine if use of bupivacaine-meloxicam reduces post-operative narcotic use over the first 3 days following surgery (time frame: 72 hours post surgery). 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 22 Nov 2024.