Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02657057
Other study ID # IMT46681770
Secondary ID
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04578899 - "The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity" N/A
Active, not recruiting NCT03556891 - Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence N/A
Not yet recruiting NCT05977634 - Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder N/A
Completed NCT01955408 - Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment N/A
Recruiting NCT06201013 - Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children N/A
Recruiting NCT03727711 - TPTNS: Home vs Hospital Treatment for Overactive Bladder N/A
Completed NCT00768521 - A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107) Phase 1
Completed NCT03625843 - Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing N/A
Completed NCT02211846 - A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder Phase 1
Completed NCT02835846 - Investigation of the Effect of the Female Urinary Microbiome on Incontinence Phase 4
Completed NCT02857816 - PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB N/A
Withdrawn NCT02320201 - Foot Neuromodulation for Overactive Bladder in Children N/A
Completed NCT02202031 - Controlling Urgency Through Relaxation Exercises N/A
Completed NCT01437670 - Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin N/A
Not yet recruiting NCT01409512 - Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder N/A
Not yet recruiting NCT01423838 - Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder Phase 4
Completed NCT01458197 - A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder. Phase 2
Terminated NCT01758848 - Physical Therapy for Overactive Bladder N/A
Withdrawn NCT01210859 - Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents N/A
Completed NCT00910845 - Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence Phase 3