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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03104101

Enrollment

Registered

2017-04-07

Start date

2014-11-01

Completion date

2016-03-05

Last updated

2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

PTNS, Neuromodulation, TPTNS, Trospium chloride

Brief summary

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

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.

Interventions

COMBINATION_PRODUCTTPTNS+Drug

one tablet Trospium Chloride 20 mg once daily Plus TPTNS

DEVICETPTNS

Surface adhesive electrodes placed on the skin above medial malleolus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026