2.1. Study Protocol
muscle behavior, slow-transit constipation, incontinence, DIE, Lower Urinary Tract Symptoms, pain, STC, LUTS
DISORDER, INCONTINENCE, MUSCLE RELAXATION, DYSPAREUNIA, CONTRACTION, DYSFUNCTION
This study reports the analysis of data on the effect of PFP on urinary, bowel, and sexual functions in a cohort of women with DIE and superficial dyspareunia from a previous RCT conducted between June 2018 and December 2019 at our tertiary center [Patients were asked to complete the Bristol Female Lower Urinary Tract Symptoms (BFLUTS) questionnaire [the BFLUTS questionnaire is a validated questionnaire designed to enable the assessment and quantification of the widest range of lower urinary tracts symptoms (LUTS) in women. It is divided into three items to evaluate bladder filling, emptying, and incontinence [the KESS questionnaire is a validated questionnaire that includes eleven questions on bowel symptoms, with a total score ranging from 0 (no symptom) to 39 (high symptoms severity). A cut-off score of ≥10 indicates constipated women. This scoring system allows patients to be divided into those suffering from a rectal evacuation disorder (RED), slow-transit constipation (STC), or a combination of the two [the FSFI questionnaire is a validated 19-item questionnaire for assessing key dimensions of sexual function in women. This questionnaire was designed and validated for assessment of female sexual function and quality of life. This questionnaire is made up of a series of items that assess desire, arousal, lubrication, orgasm, sexual satisfaction, and pain related to sexual intercourse [Study outcomes were the comparisons among groups in terms of differences in actual changes in median of questionnaires scores (Δ) between first and second examinations.Each participant underwent 3D/4D-TPU for the assessment of the LHA during rest, maximal contraction, and the maximal Valsalva maneuver. The 3D/4D transperineal ultrasound, conducted by an experienced operator (S.D.F.), preceded the bimanual gynecological examination and transvaginal ultrasound scans to prevent any discomfort. The validated OmniView-VCI technique was employed, as detailed in previous descriptions [Randomization was performed by assigning each patient randomly to either no intervention (control group) or to receive PFP sessions (experimental group) in a 1:1 ratio. Randomization was computer-generated and concealment of the assignment was ensured by using opaque envelopes which remained sealed until assignment. Therefore, women were randomly assigned to two groups, 17 in the control group and 17 in the experimental group. Four women, all from the control group, were lost to follow-up.Each patient in the experimental group received information on pelvic floor anatomy and function with the aid of anatomical tables before the start of physiotherapy. A physiotherapist experienced in PFM dysfunction and physiotherapy performed a digital PFM tone evaluation during the first and follow-up examinations after TPU. Pubococcygeus and ischiococcygeus muscle tone was assessed bilaterally at rest, during contraction, and relaxation of the pelvic floor. After the first examination, the women underwent five individual 30 min PFM physiotherapy sessions at weeks 1, 3, 5, 8, and 11. During each consecutive session, the women underwent a Thiele massage, a therapeutic intervention involving digital pressure and the subsequent stretching of muscles. This technique aims to induce muscle relaxation, restoring normal pelvic tone and enhancing the coordination of muscle behavior [The second assessment was conducted for all participants four months after randomization. During this session, the women were instructed to complete the BFLUTS, KESS, and FSFI questionnaires and rank their endometriosis-related pain symptoms, as the procedures of the initial examination. Additionally, they underwent another 3D/4D-TPU to evaluate the LHA at rest, during the maximum pelvic floor muscle contraction, and during the maximum Valsalva maneuver.The study protocol received approval from the local institutional Ethics Committee (345/2017/O/Sper), and the trial was registered on ClinicalTrials.gov (IDNCT03572075).