se of penile clamp and quality of life in urinary incontinence after prostate surgery

Phase 1

• Conditions: Prostatectomy, Stress Urinary Incontinence, Quality of Life, Nursing Care; E04.950.774.860.625; C12.777.934.852.249; E02.760.611; I01.800

• Registration Number: RBR-9y5fbs
• Lead Sponsor: Faculdade de Enfermagem da Universidade Estadual de Campinas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rinary leakage:<br>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:<br>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 Outcome Measures

Name	Time	Method
Impact on quality of life: <br>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.<br><br>;Adherence:<br>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.<br>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:<br>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.