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| Name | Class |
|---|---|
| University Ramon Llull | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Tibial Nerve Stimulation | Experimental | TENS SNS therapy is performed as follows; patient is asked to sit with legs slightly bent and an adhesive electrode is attached transcutaneously 5cm cephalic to either the right or left medial malleolus (subject choice). A surface electrode is placed on the medial surface of the ipsilateral calcaneum and both electrodes are connected to a low voltage electronic stimulator. The current is then set to the highest level tolerable to the subject (0-20 mA) and subject undergoes therapy for 30 minutes and 12 weeks (once-a-week session). Data are completed at baseline, after half therapy and after 12 weeks therapy. |
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| Percutaneous Tibial Nerve Stimulation | Active Comparator | PTNS therapy is performed as follows; patient is asked to sit with legs slightly bent. The area where the needle will be placed is cleaned with an alcohol swab. A 34 gauge needle (equivalent to an acupuncture needle) is inserted percutaneously approximately 5 cm cephalad to the medial malleolus of the right or left ankle (subject choice) at a 60 degree angle. A surface electrode is placed on the medial surface of the ipsilateral calcaneous. The needle and electrode are connected to a low voltage electrical stimulator. The current is then set to the highest level tolerable to the subject (0-20 mA) and the subject undergoes therapy for 30 minutes and 12 weeks (once-a-week session). Data are completed at baseline, after half therapy and after 12 weeks therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTNS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change from Baseline in Mean, Moderate to Severe Urgency episodes on 3-day voiding diaries at 6 and at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of complaints OR adverse effects registered during treatments |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Inés RamÃrez, MSc | Instituto Médico Tecnológico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inés RamÃrez | Barcelona | 08024 | Spain |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| TENS SNS | Device | 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. |
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A reduction in number of urgency episodes at 6 weeks and 12 weeks |
| 6 and 12 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
complaints and side effects were registered |
| From Baseline to week 12 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |