Endometriosis Clinical Trial
Official title:
Evaluation of the Efficacy of Pelvic Floor Physiotherapy in Symptomatic Patients Affected by Deep Infiltrating Endometriosis
The aim of our study is to evaluate the impact of pelvic floor physiotherapy in symptomatic
patients affected by deep infiltrating endometriosis, using 3D/4D transperineal ultrasound
for evaluation of pelvic floor morphometry, NRS (Numerical Rating Scale) for evaluation of
symptoms and validated questionnaires investigating intestinal, sexual and urinary functions.
These results will be compared with those obtained from symptomatic patients affected by deep
infiltrating endometriosis following the standard care procedure that does not provide pelvic
floor physiotherapy.
Symptomatic, nulliparous women with deep infiltrating endometriosis are included in the
study.
During the first medical examination, endometriosis related symptoms are assessed using NRS
(Numerical Rating Scale); intestinal, sexual and urinary functions are evaluated with
validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire (KESS), Female Sexual
Function Index (FSFI), Bristol Female Lower Urinary Tract Symptoms (BFLUTS)); pelvic floor
morphometry at rest, during pelvic floor contraction and during Valsalva manoeuvre is
evaluated using 3D/4D transperineal ultrasound through the assessment of the levator hiatus
area (LHA). Gynaecological examination, transvaginal and transabdominal ultrasound are
performed.
After the first medical examination, enrolled patients are randomized into two groups:
patients in Group A receive standard care procedure and pelvic floor physiotherapy; patients
in Group B receive standard care procedure only. Pelvic floor physiotherapy protocol consists
of six sessions (weeks 1, 3, 5, 8, 11 from the randomization). After four months from the
first medical examination, endometriosis related symptoms, intestinal, sexual and urinary
functions and pelvic floor morphometry are reassessed for all patients, using the same
procedures, comparing the two groups and evaluating the impact of pelvic floor physiotherapy.
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