search
Back to results

Physiotherapy in Overactive Bladder: Electrical Stimulation Treatment (OAB)

Primary Purpose

Overactive Bladder Syndrome

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
TTNS
ES+TTNS
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder Syndrome focused on measuring Overactive Bladder, Electric Stimulation, Physical Therapy Modalities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1: TTNS

Group 2: ES + TTNS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Improvement of miccional urgency and urinary urgency incontinence
We expect that patients will get better decreasing symptoms of urinary urgency and urinary incontinence urgency consequently.

Full Information

First Posted
July 13, 2017
Last Updated
April 15, 2019
Sponsor
University of Sao Paulo General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03250650
Brief Title
Physiotherapy in Overactive Bladder: Electrical Stimulation Treatment
Acronym
OAB
Official Title
Transcutaneous Tibial Nerve Electrical Stimulation Combined With Transvaginal Electrical Stimulation in Overactive Bladder Syndrome Treatment: Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 9, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
This is a clinical trial, blind and randomized study with 86 women with OAB or Mixed Urinary Incontinence with prevalence in the OAB symptoms, who were randomly and allocated into 2 equal groups. Group 1 underwent transcutaneous tibial nerve electrical stimulation (TTNS),for 30 minutes using 10Hz for frequency and 200µs for pulse. Group 2 received a combined of Vaginal electrical stimulation (ES) using a transvaginal probe applied ,for 20 minutes using 10Hz for frequency and 1ms for pulse and tibial nerve electrical stimulation, 30 minutes at the same parameters used in Group1. Both groups were treated once a week for 12 sessions. All patients were evaluated before and after treatment by a voiding diary, King´s Health questionnaire, avaliation of pelvic floor muscle function, overactive bladder questionnaire (OABV-8).The analyzed variables included day and night time frequency, urgency and urge incontinence. The sample calculation was based on the difference waited between 2 groups regarding the frequency improvment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome
Keywords
Overactive Bladder, Electric Stimulation, Physical Therapy Modalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: will be treated receiving Transcutaneous Tibial Electric Stimulation Group 2: will be treated receiving TTNS and Transvaginal Electric Stimulation
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: TTNS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2: ES + TTNS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TTNS
Intervention Description
Transcutaneous tibial electric stimulation
Intervention Type
Device
Intervention Name(s)
ES+TTNS
Intervention Description
Transvaginal electric stimulation
Primary Outcome Measure Information:
Title
Decreasing the numbers of urinary frequency during day and night
Description
We expect that patiens will decrease the void´s number during day (under 8), and during night, recovering theirs life´s quality.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Improvement of miccional urgency and urinary urgency incontinence
Description
We expect that patients will get better decreasing symptoms of urinary urgency and urinary incontinence urgency consequently.
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Ferreira, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fernanda B Giarreta
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade de São Paulo
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
55
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share participant data with other researchers.

Learn more about this trial

Physiotherapy in Overactive Bladder: Electrical Stimulation Treatment

We'll reach out to this number within 24 hrs