Home vs Office PNE Lead Removal for Overactive Bladder
(STIM Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Cleveland Clinic
Disqualifiers: Non-English speakers, No consent, Others
No Placebo Group
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.
12345How 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.
678910Eligibility 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.
+2 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: At home removalExperimental Treatment1 Intervention
Group II: In office removalActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland ClinicCleveland, OH
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Who Is Running the Clinical Trial?
The Cleveland ClinicLead Sponsor
References
A modified approach to patient's selection with improved clinical outcomes in sacral nerve modulation. [2021]Since the marketing of the percutaneous permanent tined leads (PPTL), many centres rely solely on these instead of the percutaneous nerve evaluation (PNE) as a screening tool. At our centre, we routinely perform PNE. Moreover, with our limited hospital resources, we have adopted a stricter definition of success in the patient selection process using an improvement of more than 60% as a cut-off point. This study presents our experience with sacral nerve stimulation using PPTL as an adjunct to PNE to improve the outcome of the screening method for patients suffering from refractory voiding dysfunction.
Incidence of Temporary Peripheral Nerve Stimulator Lead Tip Retention: A Retrospective Review of 80 Lead Placements. [2023]The primary objective of this study was to determine the current rate of lead fracture during temporary percutaneous peripheral nerve stimulator (PNS) lead removal at the Mayo Clinic Rochester Division of Pain Medicine.
Percutaneous nerve evaluation (PNE) for treatment of non-obstructive urinary retention: urodynamic changes, placebo effects, and response rates. [2020]To evaluate the results of percutaneous nerve evaluation (PNE) implantation in the treatment of non-obstructive urinary retention and report the changes in the urodynamic parameters.
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]To compare the patient's response rate to the Percutaneous Nerve Evaluation test (PNE) and the 1st stage tined-lead placement test (FSTLP) for sacral neuromodulation therapy (SNM).
Prospective, multicenter study to evaluate performance and safety of a re-engineered temporary lead for InterStim™ therapy evaluation. [2022]The basic evaluation or percutaneous nerve evaluation (PNE) is a method to assess pre-implantation therapeutic response in patients considering sacral neuromodulation for the treatment of refractory overactive bladder. A new PNE lead with a more robust design and greater distensibility designed to reduce the possibility of lead migration has recently been introduced to the market. The aim of this prospective, multicenter, global, postmarket study was to evaluate the clinical performance and safety of the new InterStim PNE lead with the foramen needle.
Down to the wire: Patient and family experiences of k-wire removal in a paediatric specialist clinic. [2022]K-wire removal is a common procedure in the paediatric outpatient clinic that is a source of pain and anxiety. This study examined the current parental experience of k wire removal.
A Comparative Study to Evaluate the Anesthetic Efficacy of Buffered Versus Non-buffered 2% Lidocaine During Inferior Alveolar Nerve Block. [2023]The study aimed to compare the clinical efficacy, safety, and acceptability of buffered lidocaine (8.4% sodium bicarbonate and 2% lidocaine with 1:80,000 adrenaline) versus non-buffered lidocaine (2% lidocaine with 1:80,000 adrenaline) during inferior alveolar nerve block.
Efficacy and adverse events of 4% articaine compared with 2% lidocaine on primary molar extraction: A randomised controlled trial. [2020]There is no consensus regarding the most effective anaesthetic solution for children; nerve block, especially mandibular, can be difficult for general dentists. Therefore, the study aims to compare the efficacy and the adverse events of articaine 4% with epinephrine 1:100 000 with lidocaine 2% with epinephrine 1:100 000 for primary molar extraction using buccal infiltration.
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]The purpose of this prospective, randomized, single-blinded study was to measure the degree of anesthesia obtained with 1.8 mL and 3.6 mL of 2% lidocaine with 1:100,000 epinephrine in posterior superior alveolar (PSA) nerve blocks.
Injectable local anaesthetic agents for dental anaesthesia. [2020]Data sources The following traditional databases were searched until January 2018; Cochrane Central Register of Controlled Trials (CENTRAL); the Cochrane Library; Issue 1, MEDLINE Ovid, Embase Ovid, CINHAL Plus and the Institute of Scientific Information (ISI) Web of Science. In addition, five more databases (IndMED, KoreaMED, Panteleimon, ANZCTR and Ingenta Connect) and bibliographies. References lists were also searched until January 2018 as well as handsearching of multiple relevant journals and potential sources of unpublished studies.Study selection All included studies were randomised controlled trials comparing different agents, different dosage or different concentration of local anaesthetics in clinical procedures or simulated scenarios using parallel or cross-over design with no language or year of publication restrictions. Data extraction and synthesis Two reviewers independently selected, reviewed and extracted data using a standardised form. Risk of bias was also assessed by two authors. Quality of the evidence was evaluated by the GRADE approach. Treatment effect was presented as odds ratios (OR) and risk ratios (RR) with 95% confidence intervals (CI) for binary data, while mean differences (MD) with 95% CI was used for continuous data. Statistical heterogeneity was calculated by the 'Q' statistic and I2. 'Summary findings' tables were created for eight comparisons. Subgroup analysis was performed based on the tissue anaesthetised.Results From the 123 studies (19,223 participants) on dental anaesthesia using commercially available formulations that met the inclusion criteria, 68 studies with 6615 participants were included for quantitative analysis. The comparison of 4% articaine, 1:100.000 adrenaline with 2% lidocaine, 1:100.000 adrenaline was reported as the main comparison and included the results of four studies with 203 participants with irreversible pulpitis during endodontic access and instrumentation. For the primary outcome of success, as measured by the absence of pain, the calculated RR of 1.60 (95% CI 1.10 to 2.32) favoured articaine with low heterogeneity. No evidence of difference was observed on pain during injection (MD 4.74 mm, 95% CI -1.98 to 11.46 mm) or following injection (MD 6.41 mm CI 95% 1.01 to 11.80 mm) based on three cross-over studies comparing the same formulations used for the evaluation of success.Conclusions The authors concluded there is no sufficient high quality evidence to determine which formulation is more effective. Four percent, 1:100,000 adrenaline was superior to lidocaine 2%, 1:100,000 epinephrine when measuring success on posterior teeth with irreversible pulpitis. Two percent lidocaine, 1:100,000 epinephrine was superior to 3% prilocaine 0.03 IU felypressin during surgical procedures and 4% prilocaine plain during surgical and periodontal treatment.