Evaluation of the Efficacy of Pelvic Floor Physiotherapy in Symptomatic Patients Affected by Deep Infiltrating Endometriosis
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Evaluation of the impact of pelvic floor physiotherapy on urinary function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Group A
assessment of symptoms at the first medical examination; standard care protocol; pelvic floor physiotherapy; assessment of symptoms after four months
Intervention: assessment of symptoms at the first medical examination (Diagnostic Test)
Group A
assessment of symptoms at the first medical examination; standard care protocol; pelvic floor physiotherapy; assessment of symptoms after four months
Intervention: pelvic floor physiotherapy (Procedure)
Group A
assessment of symptoms at the first medical examination; standard care protocol; pelvic floor physiotherapy; assessment of symptoms after four months
Intervention: standard care protocol (Procedure)
Group A
assessment of symptoms at the first medical examination; standard care protocol; pelvic floor physiotherapy; assessment of symptoms after four months
Intervention: assessment of symptoms after four months (Diagnostic Test)
Group B
assessment of symptoms at the first medical examination; standard care protocol; assessment of symptoms after four months
Intervention: assessment of symptoms after four months (Diagnostic Test)
Group B
assessment of symptoms at the first medical examination; standard care protocol; assessment of symptoms after four months
Intervention: assessment of symptoms at the first medical examination (Diagnostic Test)
Group B
assessment of symptoms at the first medical examination; standard care protocol; assessment of symptoms after four months
Intervention: standard care protocol (Procedure)
Outcomes
Primary Outcomes
Evaluation of the impact of pelvic floor physiotherapy on urinary function
Time Frame: After four months from the randomization
Evaluation of the impact of pelvic floor physiotherapy on symptomatic patients, using a validated questionnaire (Bristol Female Lower Urinary Tract Symptoms (BFLUTS)).
Evaluation of the impact of pelvic floor physiotherapy on pelvic floor muscles contraction
Time Frame: After four months from the randomization
Evaluation of the impact of pelvic floor physiotherapy on pelvic floor muscles contraction and pain using a gynecological examination and ultrasounds. All scans are obtained using a Voluson E6 system (GE Healthcare, Zipf, Austria) with RAB 8-4-MHz volume transducer for all acquisitions. Measurements were evaluated using a dedicated software (4DView 14.4; GE Healthcare, Zipf, Austria).
Evaluation of the impact of pelvic floor physiotherapy on intestinal function
Time Frame: After four months from the randomization
Evaluation of the impact of pelvic floor physiotherapy on symptomatic patients, using a validated questionnaire (Knowles-Eccersley-Scott-Symptom Questionnaire (KESS).
Evaluation of the impact of pelvic floor physiotherapy on sexual function
Time Frame: After four months from the randomization
Evaluation of the impact of pelvic floor physiotherapy on symptomatic patients, using a validated questionnaire (Female Sexual Function Index (FSFI)).
Secondary Outcomes
- Evaluation of the 3D-4D transperineal ultrasound as a bio-feedback tool(After 1, 3, 5, 8, 11 weeks from the randomization)
- Evaluation of uro-genital hiatus using 3D-4D transperineal ultrasound(At randomization and after four months from the randomization)
Investigators
Mohamed Mabrouk
Principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna