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

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.

Study Overview

• Status: Unknown
• Conditions: Endometriosis
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simona Del Forno, MD; Phone Number: 00393288948806; Email: simona.delforno2@unibo.it

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • Recruiting
      • Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
      • Principal Investigator: Mohamed Mabrouk
      • Principal Investigator: Renato Seracchioli
      • Contact: Simona Del Forno; Phone Number: 00393288948806; Email: simona.delforno2@unibo.it
      • Principal Investigator: Simona Del Forno
      • Sub-Investigator: Diego Raimondo
      • Sub-Investigator: Alessandro Arena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; assessment of symptoms at the first medical examination; standard care protocol; pelvic floor physiotherapy; assessment of symptoms after four months	Diagnostic test: assessment of symptoms at the first medical examination; assessment of endometriosis related symptoms 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) at the first medical examination; Procedure: pelvic floor physiotherapy; six individual sessions (weeks 1, 3 , 5, 8, 11 from the randomization) with pelvic floor consciousness exercises with mild contractions and relaxation (ex. 'kegel reverse' exercises); respiratory rate control exercises; extra exercises to perform at home are suggested.; Procedure: standard care protocol; the treatment is the same as usual in our center; Diagnostic test: assessment of symptoms after four months; assessment of endometriosis related symptoms 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) after four months from the randomization.
Experimental: Group B; assessment of symptoms at the first medical examination; standard care protocol; assessment of symptoms after four months	Diagnostic test: assessment of symptoms at the first medical examination; assessment of endometriosis related symptoms 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) at the first medical examination; Procedure: standard care protocol; the treatment is the same as usual in our center; Diagnostic test: assessment of symptoms after four months; assessment of endometriosis related symptoms 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) after four months from the randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the impact of pelvic floor physiotherapy on intestinal function	Evaluation of the impact of pelvic floor physiotherapy on symptomatic patients, using a validated questionnaire (Knowles-Eccersley-Scott-Symptom Questionnaire (KESS).	After four months from the randomization
Evaluation of the impact of pelvic floor physiotherapy on sexual function	Evaluation of the impact of pelvic floor physiotherapy on symptomatic patients, using a validated questionnaire (Female Sexual Function Index (FSFI)).	After four months from the randomization
Evaluation of the impact of pelvic floor physiotherapy on urinary function	Evaluation of the impact of pelvic floor physiotherapy on symptomatic patients, using a validated questionnaire (Bristol Female Lower Urinary Tract Symptoms (BFLUTS)).	After four months from the randomization
Evaluation of the impact of pelvic floor physiotherapy on pelvic floor muscles contraction	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).	After four months from the randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of uro-genital hiatus using 3D-4D transperineal ultrasound	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).	At randomization and after four months from the randomization
Evaluation of the 3D-4D transperineal ultrasound as a bio-feedback tool	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.	After 1, 3, 5, 8, 11 weeks from the randomization

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: May 27, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 11, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 345/2017/O/Sper

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No