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Completed

NCT Number: NCT03104101

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

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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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TPTNS+Drug

Combination Product

one tablet Trospium Chloride 20 mg once daily Plus TPTNS

TPTNS

Device

Surface adhesive electrodes placed on the skin above medial malleolus

Primary outcomes

  1. Patient satisfaction

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 7, 2017
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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