Transcutaneous Posterior Tibial Nerve Electrostimulation With Low Dose Trospium Chloride in OAB in Females

Study Overview
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Brief Summary
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This study was done to verify whether the combination of transcutaneous posterior tibial nerve stimulation (TPTNS) with low dose trospium chloride in the treatment of females with overactive bladder (OAB) would be more effective than TPTNS alone after failure of behavioral therapy.

Detailed Description
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The investigators randomized 30 women with OAB, in two groups: G I (15 patients) received 30 minutes TPTNS, three times a week; GII (15 patients) received TPTNS plus Low dose trospium chloride (20 mg once daily); all for 8 weeks. Patients were evaluated using Overactive Bladder Symptom Score questionnaire (OABSS), Incontinence Impact Questionnaire-short form 7 (IIQ-7), 3 day voiding diary and urodynamics at weeks 0 and 8.

Official Title
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Evaluation of Transcutaneous Posterior Tibial Nerve Electro Stimulation With or Without Low Dose Trospium Chloride in the Management of Overactive Bladder in Females

Conditions
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Overactive Bladder

Intervention / Treatment
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* Combination Product: TPTNS+Drug
* Device: TPTNS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Thirty adult female patients having OAB symptoms (wet type) and proved to have detrusor overactivity by urodynamics Exclusion Criteria: Patients having urinary tract infection or bladder outlet obstruction. Patients having neurological diseases. Patients having gynecological problems as genital infection, pelvic organ prolapse or genital tumors. Patients with electronic implants such as heart pacemakers. During pregnancy Patients subject to seizures

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TPTNS<br>Those who received Transcutaneous posterior tibial nerve stimulation sessions only | Device: TPTNS<br>* Surface adhesive electrodes placed on the skin above medial malleolus<br>|
| Active Comparator: TPTNS+Drug<br>Those who received Transcutaneous posterior tibial nerve stimulation sessions plus 20 mg Trospium chloride | Combination Product: TPTNS+Drug<br>* one tablet Trospium Chloride 20 mg once daily Plus TPTNS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Improvement in the questionnaire scores and associated willingness of the patient to continue treatment | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTNS, Neuromodulation, TPTNS, Trospium chloride