Clinical trial NCT02657057: Effects of Transcutaneous and Percutaneous PTNS on Idiopathic OAB
Official title: Effects of Transcutaneous and Percutaneous Posterior Tibial Nerve Stimulation on Idiopathic Overactive Bladder Syndrome: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Urge Incontinence
Overactive Detrusor
Keywords: neuromodulation
electrical estimulation
percutaneous
transcutaneous
OAB
Lead sponsor: Instituto Médico Tecnológico SL
Sponsor class: OTHER
Collaborators: name: University Ramon Llull
First posted: 2016-01-15
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if Transcutaneous Tibial Nerve Stimulation (TENS) is as effective as Percutaneous Tibial Nerve Stimulation (PTNS) as therapeutic option for subjects with Idiopathic Overactive Bladder (OAB) who have failed conventional therapy.

Detailed description: Both therapies have been proven to be effective, but very few times have been compared. PTNS and TENS SNS have been proven effective modifying bladder diary scores (change in the frequency of day and night urination, and urge incontinence), and improving subject's quality of life. Only PTNS has shown changes in urodynamic data while undergoing therapy.

The investigators hypothesize that short-term effectiveness and benefit reported, is not lower in the TENS group, if we compare both therapies in a randomized control trial.

Secondary goals are to evaluate changes in bladder diary scores (frequency of urination, nocturia, number of urgency and leakage episodes ), participants quality of life improvement scores and treatment benefit score at TBS scale, while undergoing these therapies.

Eligibility criteria: Inclusion Criteria:

* Female and male
* Age \>18 years
* Complaint urge urinary incontinence (3 or more episodes per week) OR overactive bladder (8 or more voids per day, and/or 2 or more voids per night)
* Urodynamic data of overactive detrusor
* Failed trial of conservative therapy (bladder training, fluid modification, diet modification, caffeine restriction, pelvic floor training)
* Failed trial of anticholinergic either due to inability to take the medication, adverse reaction to medication, or no improvement on medication
* Willing to complete study questionnaires and informed consent study

Exclusion Criteria:

* Presence of bladder obstruction (prostate or prolapse)
* Neurogenic bladder overactivity
* Previous pelvic organ prolapse surgery
* Unwilling and mentally incompetent to participate in study
* Pregnancy or planning to become pregnant during the study
* Presence of urinary fistula
* Recurrent or current urinary tract infection (5 or more infections in the last 12 months)
* Bladder stones
* Bladder cancer or suspected bladder cancer
* Hematuria
* Central or peripheral neurologic disorders such as Multiple Sclerosis, Parkinson's disease, spina bifida, or other spinal cord lesion
* Metal implants such as pacemaker, implantable defibrillator, or metal implants where PTNS or TENS device needs to be placed (sacrum or ankle/leg).
* Uncontrolled diabetes and diabetes with peripheral nerve involvement
* Anticoagulants treatment
* Current use of anticholinergics or use within the last 4 weeks
* Current use of botox bladder injections or bladder botox injection within the last year
* Current use of interstim therapy or currently implanted interstim device or leads
* Urinary retention or gastric retention
* Painful Bladder Syndrome/Interstitial Cystitis
* Previous PTNS treatment

Primary outcomes:
measure: Reduction from Baseline in Urinary Frequency Scores on 3-day voiding diaries at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Reduction from Baseline in the number of leakage episodes diaries at 6 weeks and at 12 weeks
timeFrame: 6 and 12 weeks
measure: Change from Baseline in Mean, Moderate to Severe Urgency episodes on 3-day voiding diaries at 6 and at 12 weeks
timeFrame: 6 and 12 weeks
measure: Reduction from Baseline in Mean Nocturia Episodes on 3-day voiding diaries at 6 and at 12 weeks
timeFrame: 6 and 12 weeks
measure: Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL)
timeFrame: 6 and 12 weeks
measure: Improved Bladder Symptom Severity Score via Overactive Bladder Questionnaire (OAB-q) at 6 and at 12 weeks
timeFrame: 6 and 12 weeks
measure: Degree of Satisfaction Score on the Treatment Benefit Scale (TBS) at 6 and at 12 weeks
timeFrame: 6 and 12 weeks
Other outcomes:
measure: Number of participants that request for continuous chronic treatment to keep the obtained response after receiving 12 PTNS/TENS sessions for OAB complaints
timeFrame: 12 weeks
measure: Number of complaints OR adverse effects registered during treatments
timeFrame: From Baseline to week 12
Locations:
city: Barcelona
country: Spain
facility: Inés Ramírez
Study officials:
affiliation: Instituto Médico Tecnológico
name: Inés Ramírez, MSc
role: PRINCIPAL_INVESTIGATOR
References: