Add-on effect of postural instructions to abdominopelvic exercise on urinary symptoms in climacteric women with stress urinary incontinence: A pilot randomized controlled trial. CURRENT STATUS: UNDER REVIEW

The aim of this study was to investigate the add-on effect of postural instructions to an abdominopelvic exercise program on urinary symptoms and QoL in perimenopausal, menopausal and postmenopausal women with stress urinary incontinence (SUI). A randomized controlled trial was performed with a total of 40 perimenopausal, menopausal and postmenopausal women with SUI aged between 46 and 75 years old. Participants were randomly assigned to two groups: a group performing an abdominopelvic exercise program (AEP) (n = 20) and a group performing abdominopelvic exercise with the addition of postural instructions (AEPPI) (n = 20). Primary outcome measures were UI symptoms, UI impact and QoL, measured by 48 h Pad Test and ICIQ-UI-SF, which were assessed at baseline, post-intervention and 3 months follow-up. Secondary outcome was patient’s satisfaction measured by VAS scale only after the intervention. Between-groups differences were observed in terms of ICIQ-UI-SF scores inmediately after intervention. Within-groups differences were observed between baseline to 3 months follow-up and between post-intervention to 3 months follow-up in AEPPI group ( p < 0.05) for ICIQ-UI-SF and UI impact. UI symptoms were improved in both groups between baseline to 3-months follow-up ( p < 0.05). Patient’s satisfaction was higher in AEPPI group ( p < 0.05). The addition of postural instructions to an abdominopelvic exercise program improves QoL and patients’ satisfaction in women with SUI.


Conclusion
The addition of postural instructions to an abdominopelvic exercise program improves QoL and patients' satisfaction in women with SUI.

Trial registration
This study was retrospectively registered at ClinicalTrials.gov under the number NCT03727945, https://clinicaltrials.gov/ct2/show/NCT03727945 Background Urinary incontinence (UI) has been defined as the complaint of any involuntary leakage of urine 1 . UI has an average overall prevalence of 20-30%. Its incidence increases with age, with an elevated prevalence in those aged 65 and over, causing loss of autonomy and quality of life (QoL) 2 , feelings of distress, loss of self-esteem and social isolation 3 . Moreover, UI leads to an important economic burden 4 . It is estimated that more than 2 million women are affected by some type of UI, with stress urinary incontinence (SUI) being the most common among affected individuals 5 6 . SUI is characterized by involuntary loss of urine without any previous feeling of a need to void, which takes place on the occasion of a physical stress (cough, lifting something heavy, or any other physical activity). SUI can be manifested individually or in combination of urge urinary incontinence (UUI) in variable proportions (mixed urinary incontinence (MUI)) 1 .
Pelvic floor muscles training (PFMT) has been recommended for all types of UI 7 . Pelvic floor does not function as an independent entity; its function is also supported by other synergistic muscles 8 . In this regard, the relationship between PFM, deep erectors and deep abdominal muscles has been confirmed by electromiography 9 10 . All these muscles are known as local system cavity 8  Women referred from urology consultations at the hospital were invited to participate in this research.
Perimenopausal, menopausal and postmenopausal women aged between 40-75 years old who had SUI or stress-predominant mixed UI (MUI) were considered for inclusion. Perimenopausal period included the time immediately prior to the menopause and the first year after menopause 18 . The type of UI was diagnosed by experienced urologists, through both urodynamic and clinical assessment. Participants were excluded if they had grade 3-4 prolapse, functional impairment (Barthel scale < 85 points), neurological or cognitive impairment (mini mental examination < 24 points), or the presence of any other type of UI. Participation was voluntary, and all participants 5 signed an informed consent prior to commencement of the study. Participants meting the eligibility criteria were allocated in two groups.

Intervention
Both groups performed 12 sessions lasting 40 minutes with a frequency of once a week 19 . The exercise programs were led by a physical therapist with 10 years of clinical experience in women's health. In the first session, postural pattern and pelvic floor muscle function were assessed. Then, women were taught how to contract PFM correctly. In the following sessions (2nd to 6th), a progressive specific pelvic floor muscle training was performed. In the 6th session, the participants were instructed on TrA activation, which was then added to the PFMT from 6th to 12th sessions. The degree of difficulty progressed according to different variables, such as the body position (supine decubitus, lateral decubitus, sitting ball, standing and functional tasks), the number of repetitions or the duration of contractions (Table 1).
All patients performed daily home training exercises during the treatment period and received a document including different abdominopelvic exercises.
In addition, prior to any specific training, participants from AEPPI group were instructed to maintain cervical alignment, scapular relocation and neutral pelvic tilt. These postural adjustments are supported by the biomechanical principles based in a "neutral spine", where function is maximized and the risk of injury is minimized 20 21 . The physical therapist provided both verbal and manual feedback in order to teach them the correct posture. In order to guide the postural correction, the physiotherapist gently pushed patients' chin while asking them to maintain cervical alignment. Then, she gently pushed their shoulders backwards to achieve scapular alignment, and their iliacs until the neutral pelvic tilt was reached. Then, participants were asked to practice 3 repetitions of this technique. During the AEP program, the physical therapist continued providing verbal and manual feedback if she deemed it necessary based on visual observation.

Outcomes
Data from all participants were collected at baseline, immediately after (post-intervention), and 3 6 months after the intervention (3 months follow-up). Evaluation was performed by the same physiotherapist. All patients completed a standard medical history questionnaire, including sociodemographic and clinical data. The type of UI was assessed according to clinical symptoms and urodynamic assessment.
Primary outcomes were UI symptoms, UI impact and ICIQ-UI-SF scores. UI symptoms were quantified through the amount of urine loss, which was measured using a 48 h Pad Test 1 . This test is a standardized method for quantifying urine leakage that can be performed at home 22 . Patients use and replace pads according to their needs over 48 h. Results are calculated by the difference between the net weight of the used pads and the sum of the non-used ones. The score of the Pad Test can be interpreted as mild (4-20 g), moderate (21-74 g) and severe UI (> 75 g) 23 24 . The ICIQ-UI-SF is made up of 3 questions assessing frequency of the leaks, amount of leakage, and impact on QoL. This questionnaire also comprises a fourth non-scored item to assess patients' perception regarding the cause and type of leakage. This item is specially useful in a clinical context.
The final score results in a sum of the 3 questions, ranging from 0 to 21, with a higher score indicating more severe UI and greater impact on QoL 25 26 27 . Secondary outcome was patient's satisfaction measured using a 100-point Visual Analogue Scale (VAS) 29 after intervention. In our study, higher scores indicate more satisfaction with treatment.
In order to calculate the sample size, an a priori power analysis was conducted using G*Power

Results
A total of 47 women with SUI were included in the trial and received either an abdominopelvic exercise program (AEP, n = 23), or an AEP combined with postural instructions (AEPPI, n = 24). Flow diagram depicts the recruitment and retention of participants in this trial (Fig. 1). Three participants in AEP group and 4 in AEPPI group dropped out the study. The total sample consisted of 40 women aged 8 between 40 and 75 years old, with a mean age of 59.47 (9.34) years. There were no statistically significant differences regarding sociodemographic and clinical variables between two groups ( Table 2). All participants complied 100% of the exercise program.
Primary outcomes ANOVA analysis showed that there were no statistically significant differences between the AEP and AEPPI groups for any variable at baseline (p > 0.05) ( Table 3).
Between-group analysis showed significant differences for the ICIQ-UI-SF score measured after the intervention, showing higher improvement for the AEPPI compared to the AEP group (1.29 points).
Within-group analysis showed non-significant differences between baseline and post-intervention for either AEP or AEPPI group. However, when comparing post-intervention and 3 months follow-up, AEPPI although baseline severity of the UI symptoms did not significantly differ between groups, the two samples were not strictly homogeneous, since participants in the AEP group presented more severe UI symptoms than women in the AEPPI group. We believe that this fact could have influenced the different recovery rate of participants. It may be that the minor improvement experienced by the participants from the AEPPI group has been influenced by the fact that they initially presented less severe UI symptoms, leading to lower chances of improving. Therefore, a longer intervention (more than 3 months) may be necessary for women with less severe symptoms to achieve an important improvement. On the other hand, could be that women with more severe UI symptoms can benefit more from this program. Regarding QoL and patients' satisfaction, AEPPI reported/showed greater improvement (reduction of 18% and 91.5% in ICIQ-UI-SF and patient's satisfaction scores, respectively) compared to AEP group (reduction of 7% and 85.5% in ICIQ-UI-SF and patient's satisfaction scores, respectively) immediately after treatment, suggesting that women with SUI performing abdominopelvic exercise supplemented with postural instructions experienced better QoL and satisfaction compared to those performing the abdominopelvic exercise program without postural instructions. Despite these findings, this study failed to find between-group differences in the midterm for QoL (3 months follow-up). This result could be considered reasonable, since after the 12 weeks training program no other intervention or home-based exercise was recommended to the participants.
It is necessary to highlight the importance of the findings of the present study since the effect of UI on QoL is as or more important as UI symptoms, according to previous literature. 22 24 28 29 No correlation has been observed between objective and subjective assessments in patients with UI.
Thus, individual perception is not directly linked to objective measures that quantify the amount of urinary loss. Some studies have demonstrated that patients' satisfaction is related to adherence to treatment 37 . In particular, it has been stated that perception of the effectiveness of the treatment is considered as a determinant factor contributing to adherence. This issue becomes especially relevant in those treatment programs that require an active role and involvement of the patient to obtain benefits from the therapy.

Strengths and limitations
To our knowledge, this study is the first pilot randomized, controlled trial to evaluate the effectiveness of abdominopelvic training supplemented with postural instructions in women with SUI. In addition, in this study the abdominopelvic exercise program, which was supervised by a physical therapist, was However, this study has several limitations. First, could be a possible limitation in relation to the generalizability of the current study was the small sample size, although the number of recruited participants was sufficient in accordance with an a priori power analysis.
Additionally, further research with higher sample sizes would help in generalizing the findings of this study. Second, the assessment method for UI symptoms in regard to measuring the urinary loss based on pads' weight (according to the 48 h Pad Test) might also be a study limitation. Third, participants' adherence to home training exercises was not registered or considered in this study, and

Consent of publication:
Patient's information was coded in order to avoid the possiblity of recognising any individual person 15 during interpretation of data or presentation of results in the manuscript. The participants received information about this procedure before they provided written consent to participate and consent for publication, which included image consent.

Availability data and materials
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing interests
The authors declare that they have no competing interests.