In the adult female Greek population,approximately 27% suffer from urinary incontinence (UI). Nowadays, the conservative, evidence-based and 'gold standard' therapy of UI involves pelvic floor muscles (PFM) training programs, which are effective when performed intensively (daily) and for at least three months' duration. Unfortunately, patients' adherence to PFM exercises programs is often compromised for various reasons (lack of patient interest, inability to exercise daily etc.). Therefore, the development of synchronous and asynchronous telerehabilitation programs has revolutionized UI treatment, because they offer an interactive environment which might increase patient motivation and improve patient's adherence to this demanding PFM exercise regime. Synchronous Telerehabilitation Programs (STP) have developed via communication platforms that allow users to connect with video, audio, phone, and chat applications (e.g. Zoom), where users can interact in real time with their therapist and follow their treatment through the PFM exercise program. Furthermore, Asynchronous Telerehabilitation Programs (ATP) have emerged via mobile applications, educational videos etc., where users can follow their treatment using the PFM exercise program at a more convenient time that fits into their personal schedule. Although some studies have examined either STP or ATP with or without face-to-face sessions, no study has investigated a blended approach of STP and ATP for the management of UI.
Given the above, the primary aim of this study is to evaluate the effectiveness of a blended STP and ATP, in comparison to face-to-face therapy sessions. A secondary objective is to investigate the level of patients' adherence, and the amount of supervision required, in a blended STP and ATP. Furthermore, the necessity of telerehabilitation programs (whether provided in a synchronous or asynchronous manner) in the field of pelvic floor dysfunctions specifically in UI, will be explored. Finally, the study will assess the usability of a telerehabilitation program (whether provided in a synchronous or asynchronous manner) in women with UI.
Greek women,
18-75 years old,
Diagnosis of Stress Urinary Incontinence (SUI) or Mixed UI (via Urodynamic examination).
Writing and reading of the Greek language
6 months after postpartum,
Systemic diseases
Malignancy,
Major gynecological surgery (i.e. total hysterectomy) over the last 10 years,
Parallel
BSATP Group
Other interventionParticipants and the therapist will communicate once weekly synchronously (e.g. through video calls with a 30 minute duration), regarding the proper execution of the PFM exercises, providing motivation etc. Additionally, participants will be advised to watch the educational videos (10 mins duration) asynchronously twice a week. In total, participants will follow a BSATP three times a week (for 12 weeks). The PFM exercise program will include endurance training (slow velocity contractions), speed training (quick contractions) and "Knack maneuver" training (pre-contraction before the increment of the intra-abdominal pressure).The PFM exercise program will be based on three assessments conducted by the therapist throughout the study (baseline, 6 weeks and 12 weeks). As a result, the PFM exercise program will be individualized to meet their needs and progressively increases in difficulty, with the exercise position being modified every two weeks (e.g. supine, side, prone ect)
FtFS Group
Other interventionParticipants will attend one weekly face-to-face session with their therapist, to discuss the progress of their treatment and ensure its seamless continuation (intra-vaginal assessment, adjustments, motivation etc.). Each session will last approximately 30 minutes. Participants will also be advised to perform the PFM program twice a week on their own e.g. at home. In total, participants will follow a PFM program three times a week (for 12 weeks), once with their therapist and twice independently. The participants in the FtFS group will follow the same PFM exercise treatment program as the BSATP group, which will be an individualized program where the position will change every two weeks and include endurance training, speed training and 'Knack maneuver' training.
Control Group (CG)
Other interventionThe participants will be advised to follow a PFM exercise treatment program at home, based on an educational home leaflet (with instructions and images about PFM exercises) that they received during their first assessment session (baseline). The participants of this group will follow a PFM exercise therapy program (through the leaflet) which will last 12 weeks and they will be advised to attend it three times a week. No face-to-face meetings or supervision will occur by the therapist during the treatment period. Similarly to the other two intervention groups, the provided PFM exercise treatment program will be individualized, will include endurance training, speed training, and 'Knack maneuver' training, and the participants will be encouraged to change their exercise position on their own every two weeks.
International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF)
The ICIQ-UI-SF is a patient-centered questionnaire. It includes questions that evaluate the frequency, severity, and impact of incontinence. The ICIQ-UI SF (range 0-21) is assessed using four scoring categories: (a) slight symptoms (1-5), (b) moderate symptoms (6-12), (c) severe symptoms (13-18) and (d) very severe symptoms (19-21).
1-hour Pad test
The 1-hour Pad test is a clinician-administered test. The pad is weighed, the participant wear the pad and executes a set of standardized exercises (squats, running on the spot etc.). After one hour the pad re-weighed and estimated the difference in the amount of urine leakage before and after the exercises in the pad.Τhe 1-hour Pad test is assessed using three scoring categories:(a) mild incontinence (\<10 ml), (b) moderate incontinence (11-50ml) and (c) severe incontinence (\>50 ml)
PERFECT assessment scheme
The PERFECT assessment scheme is a clinician-administered test. PERFECT assessment scheme will be used for digital intravaginal evaluation of PFM contraction. It assesses a) the PFMs' Power (via Modified Oxford scale) b) the PFMs' Endurance, c) the number of Repetitions the Maximum Voluntary Contraction (MVC) is performed d) the number of fast PFM contractions the participant is able to complete) the elevation of the PFMs, f) the co-contraction with other muscles (like lower abdominals) and g) the involuntary contraction of the PFM on coughing
Electromyographic (EMG) PFM's activity
The EMG is a clinician-administered test. The intravaginal probe is inserted into the vagina to measure the PFMs electromyographic (EMG) activity of the PFM contraction, displaying the results on the computer as feedback (NeuroTrac® Software). Similarly to the PERFECT assessment scheme above, it evaluates the following PFM parameters: endurance, repetitions, fast contractions and involuntary PFM contraction during coughing.
Australian Pelvic Floor Questionnaire (APFQ)
The APFQ is a patient-centered questionnaire. Australian Pelvic Floor Questionnaire (APFQ), which is standardized in the Greek language, evaluates 42 questions in four categories: bladder (1-15 question), bowel ( 16-27 question), pelvic organ prolapsed (28-32 question) and sexual function (33-42 question).The scores for each category are calculated by dividing the total score by the number of relevant questions and multiplying by 10. As a result, the scores for each area range from 0 to 10 with a total score ranging from 0 to 40 (2 questions are not included in the total score). A higher score reflects more severe symptoms
Patient Global Impression of Improvement (PGI-I Scale)
The PGI-I Scale is a patient-centered questionnaire. The participants evaluate their perceived improvement on a scale from 1 ('much better') to 7 ('much worse').
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