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

Sponsor

Ataturk Training and Research Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05127447

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence	Device: ES application Other: Sham application	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pad Test [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.
UI symptoms [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

Secondary Outcome Measures

Life quality [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).
Sexual Function [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).
Evaluation of Subjective Improvement Perception [after treatment (8th week)]
The subjective improvement of UI symptoms pf the patients after treatment was evaluated using a 4-item Likert-type scale.
Evaluation of Treatment Satisfaction [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ataturk Training and Research Hospital

Investigators

Principal Investigator: Seyda Toprak Celenay, Ankara Yildirim Beyazıt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seyda TOPRAK CELENAY, associate professor, Ataturk Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT05127447

Other Study ID Numbers:

2021/11/17

First Posted:

Nov 19, 2021

Last Update Posted:

Nov 19, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Study Results

No Results Posted as of Nov 19, 2021