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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMES group | Experimental | Neuromuscular electrical stimulation (NMES) will be applied with INNOVO brand (Atlantic Therapeutics, Galway, Ireland) device for 30 minutes 3 days a week during 4 weeks |
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| Sham group | Sham Comparator | Sham group will be applied from the same device (INNOVO brand (Atlantic Therapeutics, Galway, Ireland)), for 3 days a week for 30 minutes during 4 weeks, but no current will be given from the device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular electrical stimulation application | Device | It was applied with INNOVO brand (Atlantic Therapeutics, Galway, Ireland) device. It was applied for 30 minutes 3 days a week during 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary incontinence severity | 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. | change from baseline at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of urinary incontinence symptoms | 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. | change from baseline at 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Male with post-prostatectomy urinary incontinence
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seyda Toprak Celenay | Contact | +90312 906 1000 | sydtoprak@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Seyda Toprak Celenay | Ankara Yildirim Beyazıt University | Principal Investigator |
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| Sham neuromuscular electrical stimulation application | Device | 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. |
|
| Life quality | 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". | change from baseline at 4 weeks |
| Sexual function | 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) | change from baseline at 4 weeks |
| Patients' subjective perception of improvement | Patients' subjective perception of improvement will be questioned with a 4-point Likert scale (worse (1), same (2), better (3) and completely cured (4)). | after treatment (4th week) |
| Patient satisfaction | 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)) | after treatment (4th week) |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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