Endometriosis Clinical Trial
— endofisio-01Official title:
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | October 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
Italy | Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital | Bologna | BO |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 |
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