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

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TPTNS+Drug
TPTNS
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overactive Bladder focused on measuring PTNS, Neuromodulation, TPTNS, Trospium chloride

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    TPTNS

    TPTNS+Drug

    Arm Description

    Those who received Transcutaneous posterior tibial nerve stimulation sessions only

    Those who received Transcutaneous posterior tibial nerve stimulation sessions plus 20 mg Trospium chloride

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 9, 2017
    Last Updated
    April 3, 2017
    Sponsor
    Alexandria University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03104101
    Brief Title
    Transcutaneous Posterior Tibial Nerve Electrostimulation With Low Dose Trospium Chloride in OAB in Females
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2014 (Actual)
    Primary Completion Date
    November 30, 2015 (Actual)
    Study Completion Date
    March 5, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Alexandria University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overactive Bladder
    Keywords
    PTNS, Neuromodulation, TPTNS, Trospium chloride

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TPTNS
    Arm Type
    Active Comparator
    Arm Description
    Those who received Transcutaneous posterior tibial nerve stimulation sessions only
    Arm Title
    TPTNS+Drug
    Arm Type
    Active Comparator
    Arm Description
    Those who received Transcutaneous posterior tibial nerve stimulation sessions plus 20 mg Trospium chloride
    Intervention Type
    Combination Product
    Intervention Name(s)
    TPTNS+Drug
    Intervention Description
    one tablet Trospium Chloride 20 mg once daily Plus TPTNS
    Intervention Type
    Device
    Intervention Name(s)
    TPTNS
    Intervention Description
    Surface adhesive electrodes placed on the skin above medial malleolus
    Primary Outcome Measure Information:
    Title
    Patient satisfaction
    Description
    Improvement in the questionnaire scores and associated willingness of the patient to continue treatment
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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

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