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Clinical Trials/NCT03104101
NCT03104101
Completed
N/A

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

Alexandria University0 sites30 target enrollmentNovember 1, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Overactive Bladder
Sponsor
Alexandria University
Enrollment
30
Primary Endpoint
Patient satisfaction
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2014
End Date
March 5, 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amr Gaber Abdulfattah Ali Abulseoud

Urology Specialist

Alexandria University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Patient satisfaction

Time Frame: 1 year

Improvement in the questionnaire scores and associated willingness of the patient to continue treatment

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