Effects of External Electric Stimulating in Individuals With Urinary Incontinence After Prostatectomy

Ataturk Training and Research Hospital

Status: Unknown

Conditions: Urinary Incontinence

Treatments: Device: ES application; Other: Sham application

Study type: Interventional

Funder types: Other

Identifiers

NCT05127447

2021/11/17

Details and patient eligibility

About

The aim of this study is to investigate effects of external electric stimulating in individuals with urinary incontinence after prostatectomy.

Full description

Urinary incontinence (UI) is common in men after prostotectomy, and patients' quality of life is adversely affected. In addition, electric stimulation (ES) can be played an important role in the management of UI . However, there are limitations in clearly demonstrating the effects of ES on men with UI after prostatectomy.

Enrollment: 40 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being a male individual with stress or stress-dominant mixed UI symptoms after undergoing prostatectomy surgery for prostate cancer in the urology clinic
• Being over 40 years old
• Being 24 and over with Mini Mental Test results in individuals over 65 years of age.
• Not having residual cancerous tissue
• Volunteering to participate in the study

Exclusion criteria

• Having serious cardiovascular disease (unstable angina and arrhythmia patients, heart failure patients, etc.)
• Having sensory loss
• Having an ongoing urinary infection
• Having only urgency urinary incontinence
• Using a pacemaker
• Receiving active cancer treatment (radiotherapy, chemotherapy)
• Lack of evaluation parameters
• Not continuing the treatment regularly

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

ES group

Experimental group

Description:

External neuromuscular electrical stimulation was applied to the patients in supine position. It was applied for 30 minutes 3 days a week for 8 weeks. This stimulation consists of a total of eight external electrodes, including 2 sheaths wrapped around the thigh area and 4 electrodes for each leg. Electrodes were placed on the anterior and posterior proximal thighs, buttocks, and outside of the hips. The treatment protocol was applied with symmetrical biphasic current at a frequency of 50 Hertz (Hz), with stimulation and rest periods of 5 seconds of contraction and 5 seconds of rest.

Treatment:

Device: ES application

Sham group

Sham Comparator group

Description:

In the Sham group, for 45 minutes, 2 days a week, a vacuum electrode was connected from combined vacuum electrotherapy device over the pelvis and thigh, and only vacuum was applied while the patient was in the supine position, and no current was given from the applied device.

Treatment:

Other: Sham application