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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05127447
• Other study ID #: 2021/11/17
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2021
• Est. completion date: December 2022

Study information

• Verified date: November 2021
• Source: Ataturk Training and Research Hospital
• Contact: Seyda Toprak Celenay
• Phone: +90312 906 1000
• Email: sydtoprak[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

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

Other:
• Sham application
Only vacuum was applied and no current was given from the applied device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pad Test	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
Primary	UI symptoms	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	Life quality	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
Secondary	Sexual Function	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
Secondary	Evaluation of Subjective Improvement Perception	The subjective improvement of UI symptoms pf the patients after treatment was evaluated using a 4-item Likert-type scale.	after treatment (8th week)
Secondary	Evaluation of Treatment Satisfaction	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)