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

November 17, 2021 updated by: Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
The aim of this study is to investigate effects of external electric stimulating in individuals with urinary incontinence after prostatectomy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: ES application
Electrical stimulation (ES) application will be given to the ES group
Sham Comparator: 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.
Other: Sham application
Only vacuum was applied and no current was given from the applied device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pad Test
Time Frame: change from baseline at 8 weeks
A 1-hour pad test will be applied. Beginning with an empty bladder, a pre-weighed sanitary napkin will be inserted into the underwear. The patient will be asked to drink 500 ml of water within 15 minutes and then remain active for half an hour. Then, various activities will be made to the patient to provoke involuntary urine leakage with a full bladder. weight will be measured.
change from baseline at 8 weeks
UI symptoms
Time Frame: change from baseline at 8 weeks
The ICIQ_SF is a UI questionnaire that evaluates symptom type and severity. It consists of 6 questions in total and the total score is 3., 4., 5. It is obtained by adding the scores they get from the questions
change from baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Life quality
Time Frame: change from baseline at 8 weeks
Life quality will be assessed with King's Health Questionnaire (KHQ).This questionnaire consists of two parts and 32 items.. The minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health).
change from baseline at 8 weeks
Sexual Function
Time Frame: change from baseline at 8 weeks
Evaluation of sexual functions will be evaluated with International Index of Erectile Function IIEF-5 (IIEF-5), which is one of the most commonly used forms in men presenting with sexual complaints. It includes 5 main topics; erectile function, orgasm function, sexual desire, sexual intercourse satisfaction and general satisfaction are questioned with a total of 5 questions. Each question gets a score between 0-5. Total score; severe (5-7), moderate (8-11), mild-moderate (12-16), mild (17-21), no erectile dysfunction (22-25).
change from baseline at 8 weeks
Evaluation of Subjective Improvement Perception
Time Frame: after treatment (8th week)
The subjective improvement of UI symptoms pf the patients after treatment was evaluated using a 4-item Likert-type scale.
after treatment (8th week)
Evaluation of Treatment Satisfaction
Time Frame: after treatment (8th week)
After the 8-week treatment program, the patients' satisfaction with the treatment for UI was evaluated using a 5-item Likert-type scale.
after treatment (8th week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 17, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/11/17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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