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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05432869
Enrollment
40
Registered
2022-06-27
Start date
2022-07-15
Completion date
2022-12-15
Last updated
2022-06-27

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 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

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.

Interventions

OTHERES 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.

OTHERLifestyle advices

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

Sponsors

Ankara Yildirim Beyazıt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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 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

Design outcomes

Primary

MeasureTime frameDescription
Urinary incontinence severitychange from baseline at 4 weeksUrinary incontinence severity will be assessed with a 1-hour pad test. This amount; less than 2 grams is considered normal, 2-10 grams is mild, 10-50 grams is moderate, and over 50 grams is severe stress urinary incontinence.

Secondary

MeasureTime frameDescription
Presence of urinary incontinence symptomschange from baseline at 4 weeksUrinary incontinence symptoms will be assessed with International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF). 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. A low score in the scale indicates that urinary incontinence symptoms are less.
Life qualitychange from baseline at 4 weeksLife quality will be assessed with King Health Questionnaire. The questionnaire, consisting of thirty-two items, consists of 2 parts. In the first part, there are 2 questions questioning the general health perception and incontinence effect, and 19 questions dividing the quality of life into 7 areas (role limitations, physical limitations, social limitations, personal relationships, emotional problems, sleep/energy disorders, symptom severity measurement). In the second part, there are 11-item complaint severity scales that evaluate the presence and severity of urinary symptoms. While the best score that can be obtained on the complaint severity scale is 0, the worst score is 30, the best score that can be obtained for all King Health Questionnaire subsections is 0 and the worst score is 100.
Sexual functionchange from baseline at 4 weeksSexual function will be assessed with International Index of Erectile Function-5. 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)
Perception of Subjective Improvementafter treatment (4th week)Patients' subjective perception of improvement will be questioned with a 4-point Likert scale (worse (1), same (2), better (3) and completely cured (4))
Patients Satisfactionafter treatment (4th week)Patient satisfaction will be questioned with a 5-point Likert scale (not at all satisfied (1), dissatisfied (2), undecided (3), satisfied (4), very satisfied (5))
Compliance with Lifestyle Advicesafter treatment (4th week)Compliance of patients to the lifestyle advices will be evaluated using a 100-mm visual analog scale.

Contacts

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

Outcome results

None listed

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