Urinary Incontinence
Conditions
Interventions
This is a randomized, multicenter, controlled, and open clinical trial with parallel groups and random allocation to the Intervention Group (IG) and the Control Group (CG), using a 1:1 allocation rati
Sponsors
Universidade Federal de Minas Gerais
Universidade Federal de São João del-Rei
Universidade Federal de Jataí
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Men aged 18 years or older; presenting mild, moderate, or severe urinary incontinence, assessed using the Pad test; self-reporting preserved locomotor, visual, and auditory abilities; presenting preserved cognitive function, verified through the Six-Item Cognitive Impairment Test; without a history of urinary incontinence prior to the surgical procedure; presenting absence of postoperative complications such as urethral stricture, urinary retention, rectourethral fistula, or severe urinary tract infection; being without the use of an indwelling urinary catheter for a minimum period of 15 days after surgery, allowing for the development of self-perception regarding clinical conditions and physical adaptation to the postoperative impact; having undergone radical prostatectomy within a maximum of six months; and demonstrating willingness to participate in the scheduled face-to-face meetings
Exclusion criteria
Exclusion criteria: Individuals with spinal cord injury or diseases affecting urinary control; with a history of bladder and/or prostate surgery; reporting not using pads/liners/diapers; initiating chemotherapy or radiotherapy treatment during the intervention period; missing two consecutive face-to-face sessions; hospitalization due to postoperative complications; presenting intercurrences such as infection episodes or urethral stricture; and requiring reinsertion of an indwelling urinary catheter due to bleeding or urinary retention caused by clots
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim is to assess the severity of post-prostatectomy urinary incontinence, a continuous variable measured by evaluating urine loss in grams (Pad test). The final result of the one-hour Pad test allows classification into: continent (losses up to 1 g); mild urinary incontinence (between 1.1 and 9.9 g); moderate urinary incontinence (between 10 and 49.9 g) and severe urinary incontinence (above 50 g) | — |
Secondary
| Measure | Time frame |
|---|---|
| The aim is to measure self-efficacy, a continuous variable measured using the Self-Efficacy Scale for Pelvic Floor Exercises, an instrument composed of 17 questions, which can be answered using the Visual Analogue Scale, ranging from 0 to 100. Thirteen questions relate to self-efficacy and the other four to the expectation of results. The score obtained is calculated from the overall average of the questionnaire items, where the higher the score, the greater the self-efficacy and the expectation regarding pelvic floor muscle training.;The aim is to assess prostatic symptoms, a continuous variable measured by the International Prostate Symptoms Score (I-PSS), which consists of seven questions related to seven different prostatic symptoms: 1: incomplete bladder emptying; 2: pollakiuria; 3: intermittent urinary stream; 4: urgency; 5: weak urinary stream; 6: straining to urinate; 7: nocturia. Possible answers are graded from "never" to "almost always," with a possible score from 0 to 5. The exception is question 7, which also has a spectrum from 0 to 5, but which in turn varies from "never" to "5 times." Thus, the I-PSS score can range from 0 to 35, with 0 to 7 representing mild symptoms, 8 to 19 moderate, and 20 to 35 severe;The aim is to assess the impact of urinary symptoms on sexual dysfunction, a continuous variable measured by the International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module. This instrument consists of four items that receive scores according to the level of impairment experienced by the patient. Furthermore, the four criteria evaluated (2a, 3a, 4a, and 5a) are further subdivided (2b, 3b, 4b, and 5b) into discomfort scales, which are valuable for measuring the impact of each question on the lives of those evaluated. The responses for each of the evaluated items are graded from 0 to 3, accompanied by discomfort scales ranging from 0 to 10. It | — |
Countries
Brazil
Contacts
Public ContactGiovana De Jesus
Universidade Federal de Jataí
Outcome results
None listed