Effects of Transcutaneous and Percutaneous PTNS on Idiopathic OAB

Overactive Bladder Clinical Trial

Official title:

Effects of Transcutaneous and Percutaneous Posterior Tibial Nerve Stimulation on Idiopathic Overactive Bladder Syndrome: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657057
• Other study ID #: IMT46681770
• Status: Completed
• Phase: N/A
• First received: December 20, 2015
• Last updated: August 16, 2017
• Start date: November 2015
• Est. completion date: March 2017

Study information

• Verified date: August 2017
• Source: Instituto Médico Tecnológico SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Overactive Detrusor
• Urge Incontinence
• Urinary Bladder, Overactive
• Urinary Incontinence, Urge

Intervention

Device:
• PTNS
The needle and electrode are connected to a low voltage (9 V) electrical stimulator (URO stim2). Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 msec is increased until flexion of the big toe or fanning of all toes becomes visible, or until the subject reports a tingling sensation across the heel or bottom of the foot.
• TENS SNS
Electrodes are connected to a low voltage (9 V) electrical stimulator (URO stim2). Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 msec is increased until flexion of the big toe or fanning of all toes becomes visible, or until the subject reports a tingling sensation across the heel or bottom of the foot.

Locations

Country	Name	City	State
Spain	Inés Ramírez	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Médico Tecnológico SL	University Ramon Llull

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants that request for continuous chronic treatment to keep the obtained response after receiving 12 PTNS/TENS sessions for OAB complaints	A number of at least 50% was regarded significant	12 weeks
Other	Number of complaints OR adverse effects registered during treatments	complaints and side effects were registered	From Baseline to week 12
Primary	Reduction from Baseline in Urinary Frequency Scores on 3-day voiding diaries at 12 weeks	A reduction in urinary frequency was regarded clinically significant when a normal voiding pattern of less than 8 voids per 24 hours could be obtained	12 weeks
Secondary	Reduction from Baseline in the number of leakage episodes diaries at 6 weeks and at 12 weeks	A reduction in the number of leakage episodes of at least 30% on 3-day voiding was regarded significant	6 and 12 weeks
Secondary	Change from Baseline in Mean, Moderate to Severe Urgency episodes on 3-day voiding diaries at 6 and at 12 weeks	A reduction in number of urgency episodes at 6 weeks and 12 weeks	6 and 12 weeks
Secondary	Reduction from Baseline in Mean Nocturia Episodes on 3-day voiding diaries at 6 and at 12 weeks	A reduction of at least 25% was regarded significant	6 and 12 weeks
Secondary	Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL)	An improvement of at least 10 points was regarded significant	6 and 12 weeks
Secondary	Improved Bladder Symptom Severity Score via Overactive Bladder Questionnaire (OAB-q) at 6 and at 12 weeks	An improvement of at least 10 points was regarded significant	6 and 12 weeks
Secondary	Degree of Satisfaction Score on the Treatment Benefit Scale (TBS) at 6 and at 12 weeks	A score of 1 or 2 was regarded significant	6 and 12 weeks