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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05127447
Enrollment
40
Registered
2021-11-19
Start date
2021-12-31
Completion date
2022-12-31
Last updated
2021-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Brief summary

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

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.

Interventions

DEVICEES application

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

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

Sponsors

Ataturk Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pad Testchange from baseline at 8 weeksA 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 symptomschange from baseline at 8 weeksThe 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

MeasureTime frameDescription
Life qualitychange from baseline at 8 weeksLife 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 Functionchange from baseline at 8 weeksEvaluation 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 Perceptionafter 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 Satisfactionafter 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.

Contacts

Primary ContactSeyda Toprak Celenay
sydtoprak@hotmail.com+90312 906 1000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026