The goal of this clinical trial is to learn if a mobile app-guided pelvic floor rehabilitation program works as well as standard in-person pelvic floor rehabilitation to treat urinary leakage in adult women.
The main question it aims to answer is:
Does the app program improve quality of life related to urinary leakage as much as in-person rehabilitation?
Researchers will compare the app-based program to in-person rehabilitation to see if both lead to similar improvements in quality of life.
Participants will:
Attend one medical visit before starting to confirm they are eligible Attend one in-person training session with a physiotherapist Follow either an app-based or an in-person pelvic floor rehabilitation program for 3 months Complete quality of life questionnaires at the start and at 4 months
age >18 years
stress urinary incontinence (SUI) or mixed urinary incontinence with predominance of SUI
more than one urinary incontinence episode for week in the last month
pelvic floor muscle strength equal or greater than 2 assessed by Oxford Modified Rating Score
indwelling urinary catheter
active pelvic neoplasia
pelvic organ prolapse grade greater than or equal to 2
active urinary tract infection or macroscopic hematuria
Parallel
Mobile app based rehabilitation protocol
Other interventionMobile app based rehabilitation protocol for Stress and Mixed Urinary Incontinence in Adult Women
Presential rehabilitation program
Other interventionPresential rehabilitation program for Stress and Mixed Urinary Incontinence in Adult Women
UI-related quality of life
UI-related quality of life using the Portuguese version of the King´s Health Questionnaire (KHQ). KHQ is a disease-specific, self-administered questionnaire designed to assess the impact of UI on quality of life in women. The responses in KHQ have a four point rating system. The eight subscales ("domains") score between 0 (best) and 100 (worst). The Symptom Severity scale is scored from 0 (best) to 30 (worst). Decreases in KHQ domain scores indicate an improvement in quality of life. The minimally important difference - the smallest change in score that subjects perceive as beneficial - is 3 points for the symptom severity scale and 5 points for all other KHQ domains.
UI severity
UI severity using: the ICS pad test, the Portuguese versions of the ICIQ-bladder diary, and of the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF). The ICS pad test has been standardized by the International Continence Society and implies drinking 500mL of water and performing a protocol of activities during 1 hour. The total amount of urine leaked is determined by weighing the pad at the end. A weight difference of 1g is considered as significative. The ICIQ-bladder diary is a standardised diary that includes records of the number of incontinence episodes. The ICIQ-UI Short Form is a self-administered questionnaire for evaluating the frequency, severity and impact on quality of life of UI. It contains 4 items: frequency of urinary incontinence; amount of leakage; overall impact of urinary incontinence; self-diagnostic item. It is scored from 0 (best) to 21 (worst), considering 2.5 points for a minimal clinically important difference.
Perception of change
Perception of change by the patient using the Portuguese version of the Patient Global Impression of Change (PGIC) Scale. The PGIC Scale is is a global index that may be used to rate the response of a condition to a therapy. It is a transition scale consisting of a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to beginning treatment on a scale from 1 (Very much better) to 7 (Very much worse).
Sexual function
Sexual function using the Portuguese version of the Female Sexual Functioning Index (FSFI). The FSFI is a survey measuring the sexual functioning of women over the previous 30 days in six different domains: desire, arousal, lubrication, orgasm, satisfaction and pain. Sexual disfunction severity is classified into five categories based on FSFI total scores: severe (2-7.2), moderate (7.3-14.4), mild to moderate (14.5-21.6), mild (21.7-28.1 "cutoff value"), and no sexual disfunction (28.2-36).
Symptoms of depression/anxiety
Symptoms of depression/anxiety using the Portuguese version of the Hospital Anxiety \& Depression Scale (HADS) questionnaire. HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \>8 denotes anxiety or depression.
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