Retropubic Lidocaine vs Saline for Stress Urinary Incontinence

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

150 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug Lidocaine with Epinephrine for stress urinary incontinence?

Research shows that lidocaine, when used in a gel form, improved symptoms in patients with urge incontinence, a condition related to stress urinary incontinence. This suggests that lidocaine may help with similar bladder control issues. ^{1 2 3 4 5}

Is retropubic lidocaine safe for treating stress urinary incontinence?

Lidocaine, when used in the bladder for other conditions, has been shown to be safe with no reported side effects and plasma concentrations below toxic levels. Some studies noted discomfort with certain formulations, but no serious adverse reactions were reported. ^{1 2 6 7 8}

How does the drug Lidocaine with Epinephrine differ from other treatments for stress urinary incontinence?

Lidocaine with Epinephrine is unique because it is administered retropubically (behind the pubic bone) and acts as a local anesthetic to potentially reduce symptoms of stress urinary incontinence by numbing the area, which is different from other treatments that may focus on strengthening pelvic muscles or using surgical interventions. ^{1 4 7 9 10}

What is the purpose of this trial?

Stress urinary incontinence affects millions of women worldwide and has a profound impact on the quality of life of older individuals, their subjective health status, levels of depression and need for care. Midurethral sling placement was introduced in 1995 and remains the current gold standard for surgical management of SUI. Although the advantages of midurethral sling surgery include its high success and minimally invasive approach, approximately 10-50% of women experience acute postoperative urinary retention and are subsequently sent home with an indwelling foley catheter or clean intermittent self catheterization. Urinary retention is anxiety provoking for most patients and adds morbidity, cost, and increased utilization of healthcare resources. Additionally, catheterization of the urinary tract results in increased risk of urinary tract infection and potential need for antibiotics. Several recent studies have reported varying rates of postoperative voiding trial success depending on the type of local anesthetic used for hydrodissection; however the data is sparse and invites a more thorough investigation. Furthermore, to the investigators knowledge, no studies have systematically explored dosage or type of agent used intraoperatively on postoperative voiding function. Based on the preliminary data, the investigators hypothesize that patients receiving normal saline compared to a local anesthetic (e.g., lidocaine) will have a reduction in duration of postoperative urinary retention following retropubic midurethral sling placement.

Research Team

Lindsay Turner, MD

Principal Investigator

Department of Obstetrics and Gynecology, Allegheny Health Network

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Effectiveness of intravesical administration of lidocaine gel in females with urge and urge incontinence]. [2013]

2. China pubmed.ncbi.nlm.nih.gov

[Treatment of intravesical instillation with fulguration-hydrodistention on female interstitial cystitis]. [2023]

3. Australia pubmed.ncbi.nlm.nih.gov

On- and post-treatment symptom relief by repeated instillations of heparin and alkalized lidocaine in interstitial cystitis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Onset of the action of intravesical lidocaine after spinal cord injury. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Intravesical alkalinized lidocaine (PSD597) offers sustained relief from symptoms of interstitial cystitis and painful bladder syndrome. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Intravesical lidocaine in severe interstitial cystitis. Case report. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Intravesical lignocaine and detrusor instability. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Taking the 'sting' out of local anaesthetics. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Voiding Function After Midurethral Slings With and Without Local Anesthetic: Randomized Controlled Trial. [2018]

10. England pubmed.ncbi.nlm.nih.gov

The effect of pH and lignocaine on detrusor instability. [2019]