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

Not Applicable

Completed

• Conditions: Overactive Bladder
• Interventions: Combination Product: TPTNS+Drug; Device: TPTNS

• Registration Number: NCT03104101
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study Start: 2014-11-01
• Primary Completion: 2015-11-30
• Study Completion: 2016-03-05
• Status Verified: 2017-03
• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-04-03
• Last Update Submitted: 2017-04-03
• Study First Posted: 2017-04-07
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TPTNS+Drug	TPTNS+Drug	Those who received Transcutaneous posterior tibial nerve stimulation sessions plus 20 mg Trospium chloride
TPTNS	TPTNS	Those who received Transcutaneous posterior tibial nerve stimulation sessions only

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	1 year	Improvement in the questionnaire scores and associated willingness of the patient to continue treatment