Physiotherapy of the Pelvic Floor in Women With Deep Infiltrating Endometriosis (endofisio-01)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Unknown

Conditions: Endometriosis

Treatments: Procedure: pelvic floor physiotherapy; Diagnostic Test: assessment of symptoms at the first medical examination; Procedure: standard care protocol; Diagnostic Test: assessment of symptoms after four months

Study type: Interventional

Funder types: Other

Identifiers

NCT03572075

345/2017/O/Sper

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with clinical and ultrasound diagnosis of deep endometriosis with related symptoms (chronic pelvic pain, dysmenorrhea, dyschezia, dyspareunia, dysuria)
• Nulliparity
• Obtaining Informed Consent

Exclusion criteria

• Patients with an oncological disease or needing surgery for malignant pathologies
• Urogenital prolapse
• History of surgery for deep infiltrating endometriosis
• Congenital or acquired malformations of pelvis and pelvic floor
• History of diseases characterised by chronic pelvic pain (interstitial cystitis, irritable bowel disease, chronic vulvodynia).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Group A

Experimental group

Description:

assessment of symptoms at the first medical examination; standard care protocol; pelvic floor physiotherapy; assessment of symptoms after four months

Treatment:

Procedure: pelvic floor physiotherapy

Diagnostic Test: assessment of symptoms at the first medical examination

Procedure: standard care protocol

Diagnostic Test: assessment of symptoms after four months

Group B

Experimental group

Description:

assessment of symptoms at the first medical examination; standard care protocol; assessment of symptoms after four months

Treatment:

Diagnostic Test: assessment of symptoms at the first medical examination

Procedure: standard care protocol

Diagnostic Test: assessment of symptoms after four months