Physiotherapy in Overactive Bladder: Electrical Stimulation Treatment (OAB)

University of Sao Paulo General Hospital

Status: Completed

Conditions: Overactive Bladder Syndrome

Treatments: Device: ES+TTNS; Device: TTNS

Study type: Interventional

Funder types: Other

Identifiers

NCT03250650

63041516.7.0000.0068

Details and patient eligibility

About

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).

Full 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.

Enrollment: 86 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Group 1: TTNS

Active Comparator group

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.

Treatment:

Device: TTNS

Group 2: ES + TTNS

Experimental group

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.

Treatment:

Device: ES+TTNS