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

NCT ID: NCT05127447

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly divided into two groups (such as ES and sham groups)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ES group

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.

Group Type EXPERIMENTAL

ES application

Intervention Type DEVICE

Electrical stimulation (ES) application will be given to the ES group

Sham group

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.

Group Type SHAM_COMPARATOR

Sham application

Intervention Type OTHER

Only vacuum was applied and no current was given from the applied device

Interventions

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ES application

Electrical stimulation (ES) application will be given to the ES group

Intervention Type DEVICE

Sham application

Only vacuum was applied and no current was given from the applied device

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ataturk Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seyda TOPRAK CELENAY

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seyda Toprak Celenay

Role: PRINCIPAL_INVESTIGATOR

Ankara Yildirim Beyazıt University

Central Contacts

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Seyda Toprak Celenay

Role: CONTACT

Phone: +90312 906 1000

Email: [email protected]

Other Identifiers

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2021/11/17

Identifier Type: -

Identifier Source: org_study_id