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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104101
• Other study ID #: Alexandria University
• Status: Completed
• Phase: N/A
• First received: March 9, 2017
• Last updated: April 3, 2017
• Start date: November 1, 2014
• Est. completion date: March 5, 2016

Study information

• Verified date: March 2017
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 5, 2016
• Est. primary completion date: November 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Combination Product:
• TPTNS+Drug
one tablet Trospium Chloride 20 mg once daily Plus TPTNS

Device:
• TPTNS
Surface adhesive electrodes placed on the skin above medial malleolus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Outcome

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