Urinary Incontinence
Conditions
Brief summary
The aim of this study is to investigate the effects of neuromuscular electric stimulation on urinary symptoms, quality of life, sexual function, perception of improvement and patient satisfaction in individuals with post-prostatectomy urinary incontinence
Detailed description
One of the two most common complications after prostatectomy surgeries is urinary incontinence (UI) and the other is erectile dysfunction. There are conservative and surgical treatment options in post-prostatectomy urinary incontinence. One of the conservative treatment options is neuromuscular electrical stimulation application. Since electrical stimulation applications, used in the treatment of post-prostatectomy urinary incontinence, are usually given together with other treatment protocols, there are limitations in clearly demonstrating the effects of neuromuscular electrical stimulation on post-prostatectomy urinary incontinence.
Interventions
It was applied with INNOVO brand (Atlantic Therapeutics, Galway, Ireland) device. It was applied for 30 minutes 3 days a week during 4 weeks
DEVICESham neuromuscular electrical stimulation application
Sham group will be applied from the same device, again 3 days a week for 30 minutes during 4 weeks, but no current will be given from the device.
Sponsors
Ankara Yildirim Beyazıt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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 in the urology clinic * Being over 40 years old * Volunteering to participate in the study
Exclusion criteria
* Severe cardiovascular disease (unstable angina and arrhythmia patients, heart failure patients ect.) * Those with sensory loss * Presence of ongoing urinary infection * Only urgency urinary incontinence * Having a pacemaker * Active cancer treatment (radiotherapy, chemotherapy), * Those who have undergone Transurethral Prostatectomy (TUR-P) surgery * Those who have a problem that interferes with cooperation and understanding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary incontinence severity | change from baseline at 4 weeks | Urinary incontinence severity will be assess 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 50 grams is severe stress urinary incontinence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of urinary incontinence symptoms | change from baseline at 4 weeks | Urinary 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 quality | change from baseline at 4 weeks | Life 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 function | change from baseline at 4 weeks | Sexual 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) |
| Patients' subjective perception of improvement | after 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)). |
| Patient satisfaction | after 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)) |
Contacts
Primary ContactSeyda Toprak Celenay
Outcome results
None listed