NCT03547518

Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation

Completed NA Results posted Last updated 14 August 2023

What this trial tests

NA trial testing PTNS treatment in Overactive Bladder in 25 participants. Completed in 17 November 2022.

Timeline

13 March 2018

Primary endpoint
12 May 2022

17 November 2022

Quick facts

Lead sponsor	Corewell Health East
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	25
Start date	13 March 2018
Primary completion	12 May 2022
Estimated completion	17 November 2022
Sites	1 location across United States

Drugs / interventions tested

• PTNS treatment
• Sham treatment — full drug profile →

Conditions studied

• Overactive Bladder — all drugs for Overactive Bladder →

Sponsor

Corewell Health East — full company profile →

Who can join

18 and older, any sex, with Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Improvement in GRA for Overall Bladder Symptoms Primary · One week post induction (+/- 3 days)

Number of subjects reporting "Moderately" or "Markedly Improved" responses on the GRA after 3 interventions

Group	Value	95% CI
Active PTNS Treatment	3
Sham Treatment	2

Change From Baseline Urinary Frequency on 3 Day Voiding Diary Secondary · Baseline and 1 week post induction (+/- 3 days)

Change in number of total voids as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in urinary frequency from baseline, negative change means increase in urinary frequency from baseline.

Group	Value	95% CI
Active PTNS Treatment	5	± 6.21
Sham Treatment	1.08	± 5.38

Change From Baseline Nocturia in 3 Day Voiding Diary Secondary · Baseline and one week post induction (+/- 3 days)

Change in number of total night time urinary voids over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in number of night time voids. Negative change means increase in number of night time voids.

Group	Value	95% CI
Active PTNS Treatment	-0.64	± 2.11
Sham Treatment	0.31	± 4.05

Change From Baseline in Degree of Urgency in 3 Day Voiding Diary Secondary · Baseline and 1 week post induction (+/- 3 days)

Change in number of urinary voids recorded as urgent over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (end of treatment). Positive change means reduction in urge incontinence episodes. Negative change means increase in urge incontinence episodes.

Group	Value	95% CI
Active PTNS Treatment	4.82	± 9.42
Sham Treatment	-4.38	± 10.9

Change From Baseline in Number of Urge Incontinence Episodes in 3 Day Voiding Diary Secondary · Baseline and one week post induction (+/- 3 days)

Change in number of urge incontinence episodes over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in urge incontinence episodes. Negative change means increase in urge incontinence episodes.

Group	Value	95% CI
Active PTNS Treatment	5	± 5.66
Sham Treatment	2	± 6.43

Change From Baseline in Overactive Bladder Questionnaire-short Form Symptom Bother (OABq-SF) Secondary · Baseline and 1 week post induction (+/- 3 days)

Change from baseline in total score on a 6 question survey of extent of how much patients were bothered by bladder symptoms, with each question rated on a 6 point likert scale with 1= Not at all and 6= a very great deal. Score range 0-100. Higher score equals worse overactive bladder symptoms. Positive change means improvement in OAB symptoms. Negative change means worsening of OAB symptoms.

Group	Value	95% CI
Active PTNS Treatment	17.73	± 18.41
Sham Treatment	18.97	± 14.68

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected for 12 weeks in active treatment group and sham treatment groups. Sham patients that continued to the open label active PTNS treatment phase were monitored for 12 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active PTNS Treatment

Serious: 0/13 (0%)

Deaths: 0/13

Sham Treatment

Serious: 0/12 (0%)

Deaths: 0/12

Open Label Active PTNS Treatment

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (8 terms — click to expand)

Reaction	System	Active PTNS Treatment	Sham Treatment	Open Label Active PTNS Tre…
COVID infection	Infections and infestations	—	—	—
Atypical Chest Pain	Cardiac disorders	—	—	—
Asthmatic bronchitis	Respiratory, thoracic and mediastinal disorders	—	—	—
Urinary Tract Infection (UTI)	Infections and infestations	—	—	—
Right lower extremity cellulitis	Skin and subcutaneous tissue disorders	—	—	—
Right foot fracture	Musculoskeletal and connective tissue disorders	—	—	—
Right renal cyst	Renal and urinary disorders	—	—	—
Right lower extremity tingling	Nervous system disorders	—	—	—

Data from ClinicalTrials.gov NCT03547518 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.