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

Trial Summary

What is the purpose of this trial?

For women undergoing percutaneous nerve evaluation (PNE) for the treatment of overactive bladder the first step is the PNE interstim therapy trial. If the PNE works, patients may opt to have the interstim procedure. The purpose of this study is to see if patients who remove their PNE lead at home have the same satisfaction with the PNE trial as those women who have their lead removed in the office.

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 data supports the effectiveness of the treatment for home vs office PNE lead removal for overactive bladder?

The research indicates that the percutaneous nerve evaluation (PNE) is a useful method to assess the response in patients considering sacral neuromodulation for overactive bladder, and a new PNE lead design aims to improve performance and safety by reducing lead migration. ^{1 2 3 4 5}

How does the PNE lead removal treatment for overactive bladder differ from other treatments?

The PNE (percutaneous nerve evaluation) lead removal treatment for overactive bladder is unique because it involves removing a temporary wire used to test nerve stimulation, which can be done at home or in an office setting. This approach is different from standard drug treatments as it focuses on nerve modulation rather than medication. ^{6 7 8 9 10}

Research Team

Cecile A. Ferrando, MD MPH

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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.

I am 18 years old or older.

Exclusion Criteria

Inability to comprehend written and/or spoken English

Inability to provide informed consent

I have had sacral neuromodulation treatment before.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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 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 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 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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

A modified approach to patient's selection with improved clinical outcomes in sacral nerve modulation. [2021]

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

Incidence of Temporary Peripheral Nerve Stimulator Lead Tip Retention: A Retrospective Review of 80 Lead Placements. [2023]

3. Iran pubmed.ncbi.nlm.nih.gov

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

4. United States 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. [2011]

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

Prospective, multicenter study to evaluate performance and safety of a re-engineered temporary lead for InterStim™ therapy evaluation. [2022]

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

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

7. United States 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. [2023]

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

Efficacy and adverse events of 4% articaine compared with 2% lidocaine on primary molar extraction: A randomised controlled trial. [2020]

9. United States 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. [2013]

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

Injectable local anaesthetic agents for dental anaesthesia. [2020]