Effects of External Electrical Stimulating Applied on the Thigh in Men With Urinary Incontinence After Prostatectomy

NCT ID: NCT05432869

Last Updated: 2022-06-27

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

2022-07-15

Study Completion Date

2022-12-15

Brief Summary

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The aim of this study is to investigate the effects of external electrical stimulation applied on the thigh on urinary symptoms, quality of life, sexual function, perception of subjective improvement and satisfaction in men with urinary incontinence after prostatectomy

Detailed Description

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The most common complication after prostatectomy surgeries is urinary incontinence. There are conservative and surgical treatment options in post-prostatectomy urinary incontinence. One of the conservative treatment options is electrical stimulation application.

Electrical stimulation with the intraanal probe in men is painful and uncomfortable.

And also there are few studies, demonstrating the effects of electrical stimulation on urinary incontinence after prostatectomy in the literature.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Electrical stimulation (ES) group

ES group will be given additional external electrical stimulation to the lifestyle advices.

Group Type EXPERIMENTAL

ES and lifestyle advices

Intervention Type OTHER

The lifestyle advices include fluid consumption, diet, weight control, constipation, smoking, etc.

External electrical stimulation will be applied for 30 minutes 3 days a week during 4 weeks. Electrodes were placed on the thighs.

Control group

Control group will be given only lifestyle advices .

Group Type EXPERIMENTAL

Lifestyle advices

Intervention Type OTHER

The lifestyle advices include fluid consumption, diet, weight control, constipation, smoking, etc.

Interventions

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ES and lifestyle advices

The lifestyle advices include fluid consumption, diet, weight control, constipation, smoking, etc.

External electrical stimulation will be applied for 30 minutes 3 days a week during 4 weeks. Electrodes were placed on the thighs.

Intervention Type OTHER

Lifestyle advices

The lifestyle advices include fluid consumption, diet, weight control, constipation, smoking, etc.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being a male individual with stress or stress-dominant mixed urinary incontinence symptoms after undergoing prostatectomy surgery
* Being over 40 years old
* 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)
* Those who have a problem that interferes with cooperation and understanding
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ankara Yildirim Beyazıt University

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

+90312 906 1000

Other Identifiers

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2022/06/22

Identifier Type: -

Identifier Source: org_study_id

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