Physiotherapy of the Pelvic Floor in Women With Deep Infiltrating Endometriosis

Not Applicable

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

• Registration Number: NCT03572075
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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 Timeline

• Study First Submitted: 2018-05-27
• Study Start: 2018-06-15
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-06-28
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-12
• Primary Completion: 2019-09
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	assessment of symptoms at the first medical examination	assessment of symptoms at the first medical examination; standard care protocol; assessment of symptoms after four months
Group A	pelvic floor physiotherapy	assessment of symptoms at the first medical examination; standard care protocol; pelvic floor physiotherapy; assessment of symptoms after four months
Group A	assessment of symptoms at the first medical examination	assessment of symptoms at the first medical examination; standard care protocol; pelvic floor physiotherapy; assessment of symptoms after four months
Group A	standard care protocol	assessment of symptoms at the first medical examination; standard care protocol; pelvic floor physiotherapy; assessment of symptoms after four months
Group B	standard care protocol	assessment of symptoms at the first medical examination; standard care protocol; assessment of symptoms after four months
Group A	assessment of symptoms after four months	assessment of symptoms at the first medical examination; standard care protocol; pelvic floor physiotherapy; assessment of symptoms after four months
Group B	assessment of symptoms after four months	assessment of symptoms at the first medical examination; standard care protocol; assessment of symptoms after four months

Primary Outcome Measures

Name	Time	Method
Evaluation of the impact of pelvic floor physiotherapy on urinary function	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	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	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	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 Outcome Measures

Name	Time	Method
Evaluation of the 3D-4D transperineal ultrasound as a bio-feedback tool	After 1, 3, 5, 8, 11 weeks from the randomization	Patients are firstly asked to rest and then contract the pelvic floor muscles looking at the ultrasound screen in order to be aware of the contraction of the pelvic floor muscles and improve it. Voluson E6 system (GE Healthcare, Zipf, Austria) with RAB 8-4-MHz volume transducer is used for all acquisitions.
Evaluation of uro-genital hiatus using 3D-4D transperineal ultrasound	At randomization and after four months from the randomization	Women are firstly asked to rest and then contract the pelvic floor muscles (PFM) until the maximal cranioanterior displacement of the anorectal angle is attained.; The anorectal angle is defined as the angle between the posterior wall of the rectal ampulla and the anal canal.; 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).

Trial Locations

Locations (1)

Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital; 🇮🇹 Bologna, BO, Italy