Physiotherapy in Overactive Bladder: Electrical Stimulation Treatment

Overactive Bladder Syndrome Clinical Trial

— OAB  

Official title:

Transcutaneous Tibial Nerve Electrical Stimulation Combined With Transvaginal Electrical Stimulation in Overactive Bladder Syndrome Treatment: Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03250650
• Other study ID #: 63041516.7.0000.0068
• Status: Completed
• Phase: N/A
• Start date: March 9, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: April 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Syndrome
• Urinary Bladder, Overactive

Intervention

Device:
• TTNS
Transcutaneous tibial electric stimulation
• ES+TTNS
Transvaginal electric stimulation

Locations

Country	Name	City	State
Brazil	Universidade de São Paulo	Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 months