N/A Completed N=25 Randomized Single-blind Treatment

Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation

Overactive Bladder

Source: ClinicalTrials.gov NCT03547518 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcomePrimary: Improvement in GRA for Overall Bladder Symptoms — 3; 2 Participants

Summary

The aim of this study is to determine the efficacy of an accelerated course for percutaneous tibial nerve stimulation (PTNS) induction to treat overactive bladder symptoms. The standard 12 weekly induction treatments may be a patient burden and a more rapid induction may speed up symptomatic improvement.

Outcome Measures

Outcome	Result	p-value
PRIMARY Improvement in GRA for Overall Bladder Symptoms	3; 2	—
SECONDARY Change From Baseline Urinary Frequency on 3 Day Voiding Diary	5; 1.08	0.111
SECONDARY Change From Baseline Nocturia in 3 Day Voiding Diary	-0.64; 0.31	0.487
SECONDARY Change From Baseline in Degree of Urgency in 3 Day Voiding Diary	4.82; -4.38	0.0393 sig
SECONDARY Change From Baseline in Number of Urge Incontinence Episodes in 3 Day Voiding Diary	5; 2	0.242
SECONDARY Change From Baseline in Overactive Bladder Questionnaire-short Form Symptom Bother (OABq-SF)	17.73; 18.97	0.855

Eligibility Criteria

Inclusion Criteria

Women and men > 18 years of age
Self-reported failed conservative care of behavioral modifications and/or oral medications
An above normal urinary frequency as recorded on initial 3-day voiding diary
Self-reported bladder symptoms greater than or equal to 3 months
On a stable dose of antimuscarinics/beta-3 agonists for greater than or equal to 4 weeks, and willing to remain on the medication for the duration of the study OR discontinued antimuscarinics/beta-3 agonists for greater than or equal to 2 weeks
Capable of giving informed consent
Ambulatory and able to use toilet independently without difficulty
Capable and willing to follow all study-related procedures

Exclusion Criteria

Pregnant or planning to become pregnant during study duration
Diagnosis of neurogenic bladder
Botox use in bladder or pelvic floor muscles within past 12 months
Pacemakers or implantable defibrillators
Current urinary tract infection
Active use of neuromodulation in any other form. If patient has InterStim, must be turned off for 2 weeks for a washout period and remain off during the entirety of the study.
Current use of Transcutaneous Electrical Nerve Stimulation (TENS) in pelvic region, back or legs
Previous PTNS treatment who received greater than 6 treatments. Those who have received less than 6 treatments will be allowed to screen if the last treatment was at least 6 months prior to screening.
Use of investigational drug/device therapy within past 4 weeks
Participation in any clinical investigation involving or impacting gynecologic, urinary or renal function within past 4 weeks
Current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results

Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03547518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.