Home vs Office PNE Lead Removal for Overactive Bladder

(STIM Trial)

Overseen By Cecile A. Ferrando, M.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Non-English speakers, No consent, Others

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

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether removing a device lead at home is as satisfying as removal in a doctor's office for women undergoing a test treatment for overactive bladder. The goal is to determine if at-home removal is as effective and comfortable as the traditional office method. Women with urinary urgency incontinence or urgency-frequency syndrome considering sacral neuromodulation (a nerve stimulation treatment) might be suitable, especially if they have home support for lead removal.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve convenience and comfort in medical procedures.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these PNE lead removal methods are safe?

Research shows that the percutaneous nerve evaluation (PNE) procedure, which involves placing a temporary wire to help manage overactive bladder symptoms, is generally safe. Studies have found that many patients notice an improvement in their symptoms after just one week of this treatment. The wire used in this procedure is temporary and designed for easy removal, either at home or in a doctor's office.

PNE is usually performed in the office with local anesthesia, making it less invasive and generally well-tolerated. The trial examines whether removing the PNE wire at home is as satisfactory as removal in a doctor's office. Previous studies support the safety of the wire itself, and no major safety issues have been reported with at-home removal. Patients receive guidance during the process.

Overall, past evidence has found both at-home and in-office removal of the wire to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring different methods for removing PNE leads in patients with overactive bladder. Unlike traditional removal, which is done in a clinical setting, one approach in this trial allows patients to remove leads conveniently at home. This could significantly enhance patient comfort and reduce the need for frequent office visits, making the process more accessible and less disruptive to daily life. By comparing at-home and in-office removal, the trial aims to understand which method is more effective and patient-friendly, potentially revolutionizing how we manage overactive bladder symptoms.

What evidence suggests that this trial's methods could be effective for overactive bladder?

Research has shown that percutaneous nerve evaluation (PNE) effectively treats an overactive bladder. One study found that up to 90% of PNE trials resulted in the full use of a device that stimulates the sacral nerve, demonstrating strong effectiveness. Another review found that PNE successfully identified suitable candidates for nerve stimulation in 54% of cases. This indicates that many patients experience significant symptom improvement after the PNE trial. In this trial, participants will be assigned to either at-home or in-office removal of the PNE lead. The success rates suggest a high potential for patients to benefit from this treatment, regardless of the removal method. ^{1 2 3 4 6}

Who Is on the Research Team?

Cecile A. Ferrando, MD MPH

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for women over 18 with overactive bladder who are undergoing a nerve evaluation called PNE as part of their treatment. They must understand English, be able to consent, and have someone at home to help if they choose home removal.

Inclusion Criteria

I am receiving SNM therapy for sudden strong urges to urinate or frequent urination.

Exclusion Criteria

Inability to comprehend written and/or spoken English

Inability to provide informed consent

I have had sacral neuromodulation treatment before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

PNE Lead Placement

Percutaneous nerve evaluation (PNE) lead is placed in a standard fashion with confirmation of S3 foraminal location

1 day

1 visit (in-person)

PNE Trial

Participants undergo a trial period with the PNE lead in place to evaluate effectiveness

3-7 days

PNE Lead Removal

Removal of the PNE lead either at home or in-office, with confirmation of complete removal

1 day

1 visit (in-person or virtual)

Follow-up

Participants are monitored for satisfaction and improvement in urinary symptoms after PNE lead removal

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• At home removal
• In office removal

Trial Overview The study aims to compare patient satisfaction between two methods of removing the PNE lead: doing it at home versus in a medical office after the initial therapy trial to see which method patients prefer.

How Is the Trial Designed?

Group I: At home removal Experimental Treatment 1 Intervention

Group II: In office removal Active Control 1 Intervention

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

Buffered lidocaine (with sodium bicarbonate) provides a faster onset of action for inferior alveolar nerve blocks compared to non-buffered lidocaine, with an average onset time of 1.24 minutes versus 1.71 minutes.

Both buffered and non-buffered lidocaine showed similar effectiveness during the procedure, but the buffered solution resulted in a longer duration of anesthesia (approximately 327 minutes) and lower pain scores in the early postoperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Study to Evaluate the Anesthetic Efficacy of Buffered Versus Non-buffered 2% Lidocaine During Inferior Alveolar Nerve Block. Jain, TK., Jha, R., Tiwari, A., et al.[2023]

In a study involving 31 adult subjects, both 1.8 mL and 3.6 mL doses of 2% lidocaine with 1:100,000 epinephrine were highly effective for posterior superior alveolar nerve blocks, achieving 97% and 100% success for the second molar, respectively.

The 3.6 mL dose provided a longer duration of anesthesia for the first molar compared to the 1.8 mL dose, but both volumes had similar pain levels during administration, indicating that a larger volume can be used without increased discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anesthetic efficacy of 1.8 milliliters and 3.6 milliliters of 2% lidocaine with 1:100,000 epinephrine for posterior superior alveolar nerve blocks. Pfeil, L., Drum, M., Reader, A., et al.[2013]

In a study involving 43 children aged 6-10, both articaine 4% and lidocaine 2% demonstrated similar effectiveness for pain management during primary molar extractions using buccal infiltration.

However, children reported significantly more pain during the injection of articaine compared to lidocaine, indicating that while both anesthetics are effective, lidocaine may be a more comfortable option for initial administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and adverse events of 4% articaine compared with 2% lidocaine on primary molar extraction: A randomised controlled trial. Massignan, C., Silveira Santos, P., Cardoso, M., et al.[2020]

In a systematic review of 123 studies involving 19,223 participants, 4% articaine with 1:100,000 adrenaline was found to be more effective than 2% lidocaine with 1:100,000 adrenaline for pain relief during dental procedures, showing a relative risk of 1.60 for success in pain absence.

The review highlighted that while articaine was superior for certain dental applications, there was insufficient high-quality evidence to definitively determine the best local anesthetic formulation overall, indicating variability in effectiveness based on specific clinical scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injectable local anaesthetic agents for dental anaesthesia. Spivakovsky, S.[2020]

In a study involving 110 patients with overactive bladder, the new InterStim PNE lead demonstrated a 99% rate of motor or sensory response during lead placement, indicating its effectiveness in assessing therapeutic response before sacral neuromodulation.

The majority of participants reported significant improvements in bladder symptoms and high satisfaction with the therapy, with 88% noting better conditions at follow-up and only three minor adverse effects reported, all resolved without serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective, multicenter study to evaluate performance and safety of a re-engineered temporary lead for InterStim™ therapy evaluation. Elterman, D., Michaels, J., Margolis, E., et al.[2022]

In a review of 106 patients, the percutaneous nerve evaluation (PNE) was successful in identifying suitable candidates for sacral nerve stimulation in 54% of cases, demonstrating its effectiveness as a screening tool.

Among patients who had a successful PNE, 93% achieved success in the subsequent stage I procedure, indicating that using PNE can significantly enhance the outcomes of sacral nerve stimulation treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A modified approach to patient's selection with improved clinical outcomes in sacral nerve modulation. Richard, P., Carmel, M., Hage, B., et al.[2021]

A survey of 26 parents revealed that most relied on verbal information from the ward before their child's K-wire removal, highlighting the importance of clear communication regarding the procedure.

Many parents expressed a desire for more information about sedation and analgesia options, as only a small percentage reported receiving adequate details or pain relief for their child prior to the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Down to the wire: Patient and family experiences of k-wire removal in a paediatric specialist clinic. Holding, J., Devsam, BU.[2022]

In a study of 50 patients with 80 temporary peripheral nerve stimulator (PNS) leads, a lead fracture rate of 6.25% was observed during intentional lead removal after 60 days, indicating a notable risk of retained lead fragments.

This fracture rate aligns with previous research, which reported lead fracture rates between 3% and 21%, suggesting that while lead fractures can occur, the rates are consistent across different studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of Temporary Peripheral Nerve Stimulator Lead Tip Retention: A Retrospective Review of 80 Lead Placements. Hoffmann, CM., Coy, DS., Moeschler, SM., et al.[2023]

In a study of 100 patients with refractory overactive bladder or urinary retention, the first stage tined-lead placement test (FSTLP) showed a significantly higher positive response rate of 69% compared to 47% for the Percutaneous Nerve Evaluation test (PNE), indicating that FSTLP may be a more effective screening method for sacral neuromodulation therapy.

The long-term failure rate for patients who responded positively to FSTLP and subsequently received sacral neuromodulation treatment was low at 2.9% after an average of 2 years, suggesting that FSTLP not only identifies suitable candidates but also leads to sustained treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PNE versus 1st stage tined lead procedure: a direct comparison to select the most sensitive test method to identify patients suitable for sacral neuromodulation therapy. Leong, RK., De Wachter, SG., Nieman, FH., et al.[2011]

In a study of 45 patients with non-obstructive urinary retention, 62.2% experienced over 50% improvement in urinary symptoms after one week of percutaneous nerve evaluation (PNE) treatment.

Urodynamic tests showed significant increases in maximum flow rate and voided volume in responders, indicating that PNE is an effective intervention for improving bladder function without notable placebo effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous nerve evaluation (PNE) for treatment of non-obstructive urinary retention: urodynamic changes, placebo effects, and response rates. Sharifiaghdas, F., Mirzaei, M., Ahadi, B.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06226220

NCT06226220 | Percutaneous Nerve Evaluation Trial Time Newer data suggest up to 90% of PNE trials lead to full implantation. The ... PNE trials leading to SNM implantation and may offer less time for lead migration.

2. withpower.com withpower.com/trial/phase-urinary-bladder-overactive-3-2023-7b66b

Home vs Office PNE Lead Removal for Overactive Bladder In a review of 106 patients, the percutaneous nerve evaluation (PNE) was successful in identifying suitable candidates for sacral nerve stimulation in 54% of ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05799313/home-versus-office-removal-of-percutaneous-nerve-evaluation-pne-lead

Home Versus Office Removal of Percutaneous Nerve ... PNE Lead Removal: Patients will complete the trial within 3 to 7 days of the PNE lead being placed. At Home Removal: Patients will receive a ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11645166/

A Five-Year Retrospective Study on the Clinical Outcomes ... Results: 94% of the total (198) patients had PNE at the first trial, while 11 (6%) had tined lead. 129 (65%) patients had a positive response ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/P180046B.pdf

summary of safety and effectiveness data (ssed) Peripheral Nerve Evaluation (PNE) Lead: A percutaneous, temporary monopolar trial lead that allows the electrical pulses from the EPG to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10841569/

Sacral neuromodulation in the golden years: Treatment ... SNM is a safe and effective option in well-selected patients over the age of 75 years. Treatment success rate is comparable to younger cohorts.