Hypothesis / aims of study
Physical treatment and rehabilitation methods like biofeedback (BF), electrical stimulation (ES) and behavioral treatments are widely used for patients with lower urinary tract symptoms (LUTS), especially in the management of urinary incontinence (UI). Conservative treatments are the first choice of treatment in many pelvic floor disorders according to guidelines(1). Besides, adherence to non-pharmacological conservative treatments is crucial where efficacy depends mainly on patients’ compliance. In general, clinical trials have a tendency to focus on efficacy results, and despite the considerably safe aspect of these modalities, our knowledge about their safety and adherence to treatment is insufficient. In this context, we aimed to explore our clinical experience on safety and compliance for physical and rehabilitation modalities used in LUTS.
Study design, materials and methods
We retrospectively evaluated medical records of patients with LUTS registered to any treatment modality in our Pelvic Floor Disorders Rehabilitation Unit between March 2018 and March 2021. One hundred-two patients data with LUTS were involved in the analysis. All patients’ sex, age, BMI, co-morbid conditions and primary diagnosis of LUTS were recorded. Physical treatment regimens for LUTS were; behavioral management (BM), biofeedback (BF) and electrical stimulation (ES). The route of ES was either intravaginal (IVES) or transcutaneously as tibial nerve stimulation (TTNS). In patients with overactive bladder syndrome (OABS), behavioral management included bladder training with a weekly arrangement of voiding schedules for 8 weeks, to achieve a desired micturition interval in addition to lifestyle modifications and coping strategies for urgency. Our standard BF regimen was weekly sessions for 6 weeks. TTNS for OABS was administered twice weekly for 12 sessions and once weekly for maintenance in selected patients. IVES was given 4 days/week for a total of 20 sessions for patients with stress UI to strengthen weak pelvic floor muscles. All treatments mentioned above were subject to an extension period in case of a patient’s need. Treatments were given either alone or in combination according to the type of the dysfunction or symptom severity of the patients. Each treatment was recorded in details ie: frequency and total number of sessions, type and route of modality and adherence to treatments. During and after treatments, patients were closely monitored and any adverse event was recorded. Compliance to treatments was calculated by the ratio of number of completed sessions to number of planned treatment sessions. Patients who had completed all the planned sessions were also identified.
Results
Mean patient age was 48,96±12.79 years (range: 16-77) and mean body mass index of patients was 31.14±23.75 (18.34-42.98). Among 102 patients; 42 (41,1%) patients had OABS, 13 (12,7%) had stress UI, 42 (41,1%) had mix type of UI, 3 (2,9%) patients had interstitial cystitis and 2(1,9%) patients had pelvic organ prolapse. Twenty-five patients (24,5%) received behavioral management and 3 of them couldn’t complete behavioral treatment mainly due to the lack of willingness and low educational level (Table 1). Forty patients (39,2%) were treated with BF and 82 (80,3%) patients were treated with ES. A total of 32 patients received ES intravaginally as IVES and 68 patients received as TTNS, while 18 patients had some sort of combination treatment of IVES or TTNS either on the same treatment period or consecutively. One patient had vaginal infection during IVES treatment with no requirement to terminate treatment and another patient’s treatment was terminated due to vaginal irritation from IVES.
Interpretation of results
Behavioral management, biofeedback and electrical stimulation (intravaginally or transcutaneously on tibial nerve) seem quite safe for patients with LUTS in the conservative management of the disease. Intravaginal electrical stimulation was the only treatment modality with adverse events, but the adverse events were mild and low. Randomized controlled trials would give unbiased information about the safety of these modalities, but clinical experience is also important to observe safety results for a clinician. Compliance to all treatments was high. Unexpectedly, adherence to biofeedback treatment was lowest despite its weekly schedule, which might be a result of sociocultural tendency of our patient population for passive treatments instead of active treatments. We didn’t have a control group to compare treatment compliance, but we also consider that adherence and compliance might differ in clinical trials compared to real-life due to the artificial nature of the clinical trials.