NCT03104101

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
Last Updated

April 7, 2017

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

March 9, 2017

Last Update Submit

April 3, 2017

Conditions

Overactive Bladder

Keywords

PTNSNeuromodulationTPTNSTrospium chloride

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

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

    1 year

Study Arms (2)

TPTNS

ACTIVE COMPARATOR

Those who received Transcutaneous posterior tibial nerve stimulation sessions only

Device: TPTNS

TPTNS+Drug

ACTIVE COMPARATOR

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

Combination Product: TPTNS+Drug

Interventions

TPTNS+DrugCOMBINATION_PRODUCT

one tablet Trospium Chloride 20 mg once daily Plus TPTNS

TPTNS+Drug
TPTNSDEVICE

Surface adhesive electrodes placed on the skin above medial malleolus

TPTNS

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Thirty adult female patients having OAB symptoms (wet type) and proved to have detrusor overactivity by urodynamics

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urology Specialist

Study Record Dates

First Submitted

March 9, 2017

First Posted

April 7, 2017

Study Start

November 1, 2014

Primary Completion

November 30, 2015

Study Completion

March 5, 2016

Last Updated

April 7, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share