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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-01

Study Completion Date

2016-03-05

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.

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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.

Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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TPTNS

Those who received Transcutaneous posterior tibial nerve stimulation sessions only

Group Type ACTIVE_COMPARATOR

TPTNS

Intervention Type DEVICE

Surface adhesive electrodes placed on the skin above medial malleolus

TPTNS+Drug

Those who received Transcutaneous posterior tibial nerve stimulation sessions plus 20 mg Trospium chloride

Group Type ACTIVE_COMPARATOR

TPTNS+Drug

Intervention Type COMBINATION_PRODUCT

one tablet Trospium Chloride 20 mg once daily Plus TPTNS

Interventions

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TPTNS+Drug

one tablet Trospium Chloride 20 mg once daily Plus TPTNS

Intervention Type COMBINATION_PRODUCT

TPTNS

Surface adhesive electrodes placed on the skin above medial malleolus

Intervention Type DEVICE

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

1. Patients having urinary tract infection or bladder outlet obstruction.
2. Patients having neurological diseases.
3. Patients having gynecological problems as genital infection, pelvic organ prolapse or genital tumors.
4. Patients with electronic implants such as heart pacemakers.
5. During pregnancy
6. Patients subject to seizures

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes