Prostatectomy, Stress Urinary Incontinence, Quality of Life, Nursing Care
Conditions
Interventions
Two penile clamps will be used: a new model type hinge, which will be the experimental treatment (Disur@) and one with Cunningham design, which will be the active control. The total number of particip
Device
Sponsors
Faculdade de Enfermagem da Universidade Estadual de Campinas
Universidade Federal do Ceará
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: have stress urinary incontinence; have completed prostatectomy or transurethral resection for at least one year; have satisfactory score on the Mini Mental State Examination; have normal sensation in the perineum and the penis by physical examination; perineal intact skin; good manual dexterity demonstrated with installing and removing the clamp; to read and write or come with caregiver or family member, in the case of illiterate patients.
Exclusion criteria
Exclusion criteria: be performing radiotherapy or chemotherapy for prostate tumor; have symptoms of urge urinary incontinence or urge incontinence; prior urodynamic study demonstrating detrusor overactivity or low compliance; present neurological disorders or other conditions that alter the perineal sensitivity, manual dexterity or change in cognitive function; provide blood flow velocity in lower systolic peak 10ml per seconds in the flaccid penis; be in use of penile prosthesis; be in the presence of urinary tract infection, but after resolution of the urinary tract infection, may be part of the survey, provided it meets the other eligibility criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary leakage: Urinary leakage will be assessed through the bladder diary records and absorbent testing (pad test), performed before and after the use of each penile clamp; from the realization of a range of at least 5% in the pre and post intervention measurements.;Safety: Safety will be assessed by Doppler ultrasound of the penis, daily record for evaluation of adverse events and skin assessment; demonstrated from the reduced blood flow in the penile arteries below 10 ml / sec; presence of adverse events and skin changes associated with the use of penile clamp. | — |
Secondary
| Measure | Time frame |
|---|---|
| Impact on quality of life: The impact on quality of life will be assessed by the ICIQ-SF (International Consultation on Incontinence Questionnaire Short Form) and WHOQOL-Bref (World Health Organization Quality of Life-Bref), comparing the difference in the scores before and after use of each clamp. ;Adherence: The adherence will be assessed by recording the frequency of urination and urinated volumes in the bladder diary and the placement hours and withdrawing of penile clamp. The adhesion percentage is calculated by the following formula:% adherence = (NXA / 28) x 100 where: N is the is the number of days used the clamp for 8 hours over the last seven days and A is the number of times who opened the clamp in 8 hours (expected are four times) in the last seven days.;Satisfaction: The satisfaction will be assessed through a specific questionnaire, covering items related to the comfort and effectiveness of penile clamps, developed and validated for this purpose. | — |
Countries
Brazil
Contacts
Public ContactJuliana;Maria Helena Costa;Lopes
Faculdade de Enfermagem da Universidade Estadual de Campinas;Faculdade de Enfermagem da Universidade Estadual de Campinas
Outcome results
None listed