NCT03250650

Brief Summary

To evaluate the efficacy of combined transvaginal electrical stimulation (ES) and transcutaneous tibial nerve electrical stimulation (TTNS) in the treatment of female overactive bladder syndrome (OAB).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

July 13, 2017

Last Update Submit

April 15, 2019

Conditions

Overactive Bladder Syndrome

Keywords

Overactive BladderElectric StimulationPhysical Therapy Modalities

Outcome Measures

Primary Outcomes (1)

  • Decreasing the numbers of urinary frequency during day and night

    We expect that patiens will decrease the void´s number during day (under 8), and during night, recovering theirs life´s quality.

    1 month

Secondary Outcomes (1)

  • Improvement of miccional urgency and urinary urgency incontinence

    2 months

Study Arms (2)

Group 1: TTNS

ACTIVE COMPARATOR

Intervention for Group 1: transcutaneous tibial nerve electric stimulation (TTNS), using a Device Dualpex 961(Quark medical), with 2 silicone electrode in the tibial nerve path, being one on the lower border of the medial malleolus and another one, 10cm above. Once a week for 12 weeks. The parameters used on device were, 200 microseconds for pulse time and 10Hz for Frequency, during 30 minutes.

Device: TTNS

Group 2: ES + TTNS

EXPERIMENTAL

Intervention for Group 2: transvaginal electric stimulation plus transcutaneous tibial nerve electric stimulation (ES + TTNS), using a Device Dualpex 961(Quark medical), with transvaginal electrode, located inside the vagina. Once a week for 12 weeks. The parameters used on device were 1milisecond for pulse time and 10Hz for Frequency, during 20 minutes. After transvaginal stimulation, the tibial stimulation will be applied like described on Group 1.

Device: ES+TTNS

Interventions

TTNSDEVICE

Transcutaneous tibial electric stimulation

Group 1: TTNS
ES+TTNSDEVICE

Transvaginal electric stimulation

Group 2: ES + TTNS

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women diagnosed with Overactive Bladder Syndrom no neurogenic or Mixed Incontinence Urinary with overactive bladder´s predominance symptoms more than 6 months.
  • Over 18 years old.
  • Normal cognitive level to understand the orientations during the treatment.

You may not qualify if:

  • Stress Urinary Incontinence
  • Drugs treatment for overactive bladder
  • Pregnant women
  • Neurologic diseases
  • Urinary infecction
  • Cystocele, rectocele and uterine prolapse
  • Infectious contagious diseases
  • Metal implants on the hip or lower members
  • Cardiac pacemaker
  • Bladder tumor
  • Vaginal infecction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de São Paulo

São Paulo, São Paulo, 55, Brazil

Location

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 Officials

  • Elizabeth A Ferreira, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Fernanda B Giarreta

    University of Sao Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All the questionnaires (OABV-8, King´s Health, Anamnesis), Function Avaliation of Pelvic Floor Muscles, before and after treatment will be conduced by other person who is not the responsable for the research.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group 1: will be treated receiving Transcutaneous Tibial Electric Stimulation Group 2: will be treated receiving TTNS and Transvaginal Electric Stimulation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

July 13, 2017

First Posted

August 16, 2017

Study Start

March 9, 2017

Primary Completion

April 30, 2018

Study Completion

June 30, 2018

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

There is no plan to share participant data with other researchers.

Locations

BR(1)