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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03572075
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Mabrouk, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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.


Condition or disease Intervention/treatment Phase
Endometriosis 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Pelvic Floor Physiotherapy in Symptomatic Patients Affected by Deep Infiltrating Endometriosis
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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.




Primary Outcome Measures :
  1. 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).

  2. 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)).

  3. 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)).

  4. 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).


Secondary Outcome Measures :
  1. Evaluation of uro-genital hiatus using 3D-4D transperineal ultrasound [ Time Frame: 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).


  2. Evaluation of the 3D-4D transperineal ultrasound as a bio-feedback tool [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572075


Contacts
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Contact: Simona Del Forno, MD 00393288948806 simona.delforno2@unibo.it

Locations
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Italy
Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital Recruiting
Bologna, BO, Italy, 40138
Contact: Simona Del Forno    00393288948806    simona.delforno2@unibo.it   
Principal Investigator: Mohamed Mabrouk         
Principal Investigator: Renato Seracchioli         
Principal Investigator: Simona Del Forno         
Sub-Investigator: Diego Raimondo         
Sub-Investigator: Alessandro Arena         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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Responsible Party: Mohamed Mabrouk, Principal investigator, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT03572075    
Other Study ID Numbers: 345/2017/O/Sper
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Cytarabine
Methotrexate
Etoposide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Dermatologic Agents
Folic Acid Antagonists
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors