Clinical trial NCT03572075: Physiotherapy of the Pelvic Floor in Women With Deep Infiltrating Endometriosis
Official title: Evaluation of the Efficacy of Pelvic Floor Physiotherapy in Symptomatic Patients Affected by Deep Infiltrating Endometriosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Evaluation of the impact of pelvic floor physiotherapy on intestinal function
timeFrame: After four months from the randomization
measure: Evaluation of the impact of pelvic floor physiotherapy on sexual function
timeFrame: After four months from the randomization
measure: Evaluation of the impact of pelvic floor physiotherapy on urinary function
timeFrame: After four months from the randomization
measure: Evaluation of the impact of pelvic floor physiotherapy on pelvic floor muscles contraction
timeFrame: After four months from the randomization
Secondary outcomes:
measure: Evaluation of uro-genital hiatus using 3D-4D transperineal ultrasound
timeFrame: At randomization and after four months from the randomization
measure: Evaluation of the 3D-4D transperineal ultrasound as a bio-feedback tool
timeFrame: After 1, 3, 5, 8, 11 weeks from the randomization
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
state: BO
Study officials:
References: