Retropubic Lidocaine vs Saline for Stress Urinary Incontinence

No longer recruiting at 4 trial locations

Overseen By AHN Clinical Trials Contact

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: West Penn Allegheny Health System

Disqualifiers: Local anesthetic allergy, Spinal anesthesia, Voiding dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores better ways to manage stress urinary incontinence, a condition that causes unintentional urine leakage. Researchers are testing whether using a local anesthetic called lidocaine during surgery can reduce the duration of postoperative urination difficulties in women. Two groups will be compared: one receiving lidocaine (also known as Xylocaine or Lignocaine) and the other receiving saline mixed with epinephrine. Women with stress urinary incontinence who plan to undergo midurethral sling surgery, without prior urination issues, may be suitable for this study. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that lidocaine, when combined with epinephrine, is generally safe for use in surgeries. One study found that patients who received a similar mix of lidocaine and epinephrine for a different urinary procedure experienced only minor side effects, suggesting the treatment's safety.

Since this trial is in Phase 4, lidocaine with epinephrine has already been approved for other uses. This phase typically evaluates safety in a larger group of people. The existing approval and current study phase indicate a strong safety record.

In summary, both lidocaine with epinephrine and the saline solution used for comparison are considered safe based on past studies and approval status. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the use of 0.5% lidocaine with epinephrine for stress urinary incontinence because it offers a targeted approach to managing pain during surgery by being injected retropubically. Unlike standard treatments like pelvic floor exercises or surgical slings, this method delivers a local anesthetic directly to the affected area, potentially reducing pain and discomfort immediately during procedures. The addition of epinephrine helps prolong the numbing effect, which might lead to more effective and longer-lasting pain relief compared to traditional options. This approach could enhance patient comfort and recovery during surgeries for stress urinary incontinence.

What evidence suggests that this trial's treatments could be effective for stress urinary incontinence?

In this trial, participants will receive either lidocaine with epinephrine or normal saline with epinephrine. Research has shown that lidocaine with epinephrine can reduce issues such as difficulty urinating after surgery for stress urinary incontinence. One study found that patients who received lidocaine experienced better urine flow post-surgery compared to those who did not. Lidocaine also manages pain during and after procedures, promoting a smoother recovery. Past trials have demonstrated that combining lidocaine with epinephrine enhances these benefits, potentially reducing the need for additional treatments like catheter use. This combination is often used because epinephrine prolongs the effects of lidocaine, increasing its effectiveness. ^{5 6 7 8 9}

Who Is on the Research Team?

Lindsay Turner, MD

Principal Investigator

Department of Obstetrics and Gynecology, Allegheny Health Network

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older who can give consent and speak English. It's designed for those undergoing midurethral sling surgery to treat stress urinary incontinence, aiming to reduce postoperative urinary retention.

Inclusion Criteria

English speaking

I am mentally capable of understanding and agreeing to participate.

Exclusion Criteria

I have trouble emptying my bladder fully, with more than 150 mL of urine left after voiding.

I am scheduled to receive spinal anesthesia for my procedure.

A known intolerance or allergic reaction to local anesthetics

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Postoperative

Participants undergo midurethral sling surgery with either lidocaine or saline for hydrodissection. Postoperative voiding trial conducted 1-2 hours after surgery.

1 day

1 visit (in-person)

Postoperative Pain and Recovery

Participants assess postoperative pain using VAS scale at 2 and 6 hours post-surgery, with follow-up pain assessments through postoperative day #7.

1 week

Follow-up

Participants are monitored for satisfaction and quality of life, with a follow-up visit at 6 weeks to assess patient satisfaction using a Likert scale.

6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine with Epinephrine
• Normal Saline with Epinephrine

Trial Overview The study compares the effects of injecting normal saline with epinephrine versus lidocaine with epinephrine during surgery on the duration of postoperative urinary retention in patients receiving a midurethral sling.

How Is the Trial Designed?

Group I: 0.5% lidocaine with epinephrine Experimental Treatment 1 Intervention

On the day of surgery, the operating room pharmacist will prepare 20 cc of either study drug (0.5% lidocaine with epinephrine 1:200,000) or normal saline with epinephrine 1:200,000) in identical appearing 20cc syringes to be injected retropubically. Our group's routine clinical practice is to inject 20cc of 0.5% lidocaine with epinephrine 1:200,000 retropubically along the path of the midurethral sling trocars. Suburethral injection of local anesthestic will be performed at surgeon discretion. Surgical teams, anesthesia teams and patients will be blinded to allocation assignment. The investigational drug pharmacist will maintain the randomization sequence.

Group II: Normal saline with epinephrine Active Control 1 Intervention

On the day of surgery, the operating room pharmacist will prepare 20 cc of either study drug (0.5% lidocaine with epinephrine 1:200,000) or normal saline with epinephrine 1:200,000) in identical appearing 20cc syringes to be injected retropubically. Our group's routine clinical practice is to inject 20cc of 0.5% lidocaine with epinephrine 1:200,000 retropubically along the path of the midurethral sling trocars. Suburethral injection of local anesthestic will be performed at surgeon discretion. Surgical teams, anesthesia teams and patients will be blinded to allocation assignment. The investigational drug pharmacist will maintain the randomization sequence.

Lidocaine with Epinephrine is already approved in European Union, United States, Canada, Japan, China for the following indications:

Approved in European Union as Xylocaine for:

• Local anesthesia
• Pain relief
• Cardiac arrhythmias

Approved in United States as Lidocaine for:

• Local anesthesia
• Pain relief
• Cardiac arrhythmias
• Postoperative pain management

Approved in Canada as Lignocaine for:

• Local anesthesia
• Pain relief
• Cardiac arrhythmias

Approved in Japan as Xylocaine for:

• Local anesthesia
• Pain relief

Approved in China as Lidocaine for:

• Local anesthesia
• Pain relief
• Cardiac arrhythmias

Who Is Running the Clinical Trial?

West Penn Allegheny Health System

Lead Sponsor

Trials

36

Recruited

6,000+

AHN Research Institute

Collaborator

Published Research Related to This Trial

In a study of 32 individuals with spinal cord injuries, intravesical lidocaine demonstrated a rapid onset of action, with a significant decrease in systolic blood pressure observed at an average of 98.1 seconds after instillation in 45% of participants.

This quick response time is crucial for managing autonomic dysreflexia, a condition that can cause dangerous spikes in blood pressure in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Onset of the action of intravesical lidocaine after spinal cord injury. Solinsky, R., Tam, K., Linsenmeyer, TA.[2020]

In a study of 90 patients undergoing retropubic midurethral sling procedures, periurethral infiltration of bupivacaine resulted in significantly lower pain scores at 6 to 7 hours post-surgery compared to normal saline, indicating its efficacy in pain management.

However, bupivacaine did not improve postoperative voiding function, as the rates of voiding dysfunction were similar between the bupivacaine and saline groups. Additionally, preoperative phenazopyridine was associated with a lower rate of urinary retention, suggesting it may be beneficial for postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voiding Function After Midurethral Slings With and Without Local Anesthetic: Randomized Controlled Trial. Dueñas-Garcia, OF., Patterson, D., De la Luz Nieto, M., et al.[2018]

Using an intravesical alkaline solution significantly increased bladder capacity in patients with detrusor instability and low bladder compliance by 35.9% and 27.5%, respectively, compared to saline.

The addition of lignocaine to the alkaline solution further enhanced bladder capacity in patients without bladder outflow obstruction, but it worsened instability in some patients with outflow obstruction, highlighting the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of pH and lignocaine on detrusor instability. Sethia, KK., Smith, JC.[2019]

In a study involving 20 patients, intravesical lignocaine solution significantly increased bladder capacity in 19 patients and lowered maximum detrusor pressure during bladder filling in 16 patients, indicating its potential efficacy in treating detrusor instability.

The effects of lignocaine were generally short-lived, lasting longer than 24 hours in only one patient, suggesting that while it can provide temporary relief, further research is needed to understand its long-term effectiveness and mechanism of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravesical lignocaine and detrusor instability. Higson, RH., Smith, JC., Hills, W.[2019]

A patient with severe interstitial cystitis experienced significant pain relief and anti-inflammatory effects from repeated vesical instillations of lidocaine, demonstrating its potential as an effective treatment for this condition.

The treatment was safe, as plasma lidocaine levels remained below toxic thresholds and no adverse reactions were reported, indicating a favorable safety profile for lidocaine instillation in managing interstitial cystitis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravesical lidocaine in severe interstitial cystitis. Case report. Asklin, B., Cassuto, J.[2019]

In a study involving 32 patients, 2% plain lignocaine was found to be more painful than 0.5% plain lignocaine, indicating that higher concentrations can increase injection discomfort.

The addition of adrenaline to lignocaine significantly increased pain during injection, and the presence of sodium metabisulphite also heightened discomfort, suggesting that formulation components can impact patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taking the 'sting' out of local anaesthetics. Long, CC., Motley, RJ., Holt, PJ.[2019]

In a study of 102 patients with interstitial cystitis/painful bladder syndrome, treatment with intravesical alkalinized lidocaine (PSD597) resulted in significantly improved bladder symptoms compared to placebo, with 30% of patients reporting moderate to marked improvement three days after treatment.

PSD597 was found to be safe, with peak serum lidocaine levels remaining well below toxic levels, indicating it may avoid the systemic side effects associated with oral medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravesical alkalinized lidocaine (PSD597) offers sustained relief from symptoms of interstitial cystitis and painful bladder syndrome. Nickel, JC., Moldwin, R., Lee, S., et al.[2022]

In a study of 31 patients with urge incontinence who had not responded to previous treatments, repeated instillations of Lidocaine gel over 11 days led to significant improvements in urge symptoms and a reduction in micturition frequency.

The treatment resulted in increased bladder capacity for patients with initially lower capacity, improved maximum urethral closing pressure, and no observed side effects, suggesting that intravesicular Lidocaine therapy is a safe and effective option for resistant cases of urge incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of intravesical administration of lidocaine gel in females with urge and urge incontinence]. Gassner, K., Briel, RC.[2013]

The combination of intravesical instillation of heparin and alkalized lidocaine, along with hydrodistension and transurethral fulguration, significantly improved symptoms of interstitial cystitis in female patients, as evidenced by reductions in symptom scores and increases in bladder capacity over a 12-month follow-up period.

This treatment approach was found to be effective and may reduce the economic burden on patients, suggesting it could be a preferred option for managing interstitial cystitis, especially when combined with hydrodistension and fulguration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of intravesical instillation with fulguration-hydrodistention on female interstitial cystitis]. Xin, P., Zhang, H., Jiang, ZM.[2023]

A 12-week treatment of intravesical instillations combining heparin and alkalized lidocaine was found to be effective in 76.7% of patients with interstitial cystitis by the end of the treatment, with significant symptom improvement noted as early as the fourth instillation.

The treatment was safe, with no severe adverse events reported, and its effects were maintained for up to 6 months after the last instillation, although efficacy gradually diminished over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On- and post-treatment symptom relief by repeated instillations of heparin and alkalized lidocaine in interstitial cystitis. Nomiya, A., Naruse, T., Niimi, A., et al.[2022]

Citations

1. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.16647

Alkalinised lidocaine as an anaesthetic before ... Secondary outcomes included adverse effects such as post-void residual urine volumes requiring catheterisation, urinary tract infection, ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/45/NCT03913845/Prot_SAP_000.pdf

28 July 2023 Previous version: 06 May 2022 NCT03913845 To compare the impact of retropubic lidocaine versus normal saline on postoperative urinary retention in patients undergoing retropubic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6034990/

Randomized Controlled Trial to Assess the Impact of ... In this pilot study of 23 asymptomatic women, intraurethral administration of lidocaine did not decrease VE compared to placebo.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429598006062

Iontophoresis as a new method of delivering local ... Local anesthesia was provided by 4% lidocaine with 1 in 100,000 epinephrine administered over 10 minutes using an iontophoretic catheter. Pain was assessed by ...

5. go.drugbank.com go.drugbank.com/drugs/DB00668/clinical_trials?conditions=DBCOND0128715&phase=4&purpose=prevention&status=completed

Epinephrine Completed Phase 4 Trials for Stress ... Epinephrine Completed Phase 4 Trials for Stress Incontinence (Female) (Male) Prevention ... The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11913603/

Alkalinised lidocaine as an anaesthetic before ... Primary Outcome – VAS Pain Score. The mean VAS pain score was significantly lower following intravesical alkalinised lidocaine (mean 21.3 mm, 95 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00427648

Local Anesthetic Treatments for Overactive Bladder Comparison(s): We propose a randomized, prospective double-blinded controlled trial to determine if a three-week trial of intravesical alkalized lidocaine ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0029784400007146

Urethral anesthesia for periurethral bulking procedures in ... A total of 20–25 mL of 1% lidocaine with 1:200,000 epinephrine was used as described. All patients tolerated the procedure in an acceptable fashion. Minor side ...

9. contemporaryobgyn.net contemporaryobgyn.net/view/urodynamics-and-the-role-of-lidocaine

Urodynamics and the role of lidocaine The use of 2% intraurethral lidocaine does not have any statistically or clinically significant effect on urodynamic filling or voiding ...