Endometriosisendofisio-01NCT03572075
Physiotherapy of the Pelvic Floor in Women With Deep Infiltrating Endometriosis
A study testing assessment of symptoms at the first medical examination, pelvic floor physiotherapy and assessment of symptoms after four months in people with Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- assessment of symptoms at the first medical examination, pelvic floor physiotherapy and assessment of symptoms after four months
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2018to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with clinical and ultrasound diagnosis of deep endometriosis with related symptoms (chronic pelvic pain, dysmenorrhea, dyschezia, dyspareunia, dysuria)
- Nulliparity
- Obtaining Informed Consent
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
Bologna, BO, 40138
Simona Del Forno, 00393288948806, simona.delforno2@unibo.it
Mohamed Mabrouk
About this study
Official 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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- assessment of symptoms at the first medical examination, pelvic floor physiotherapy, standard care protocol, assessment of symptoms after four months
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of symptoms at the first medical examinationDiagnostic test
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
pelvic floor physiotherapyProcedure or surgery
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.
standard care protocolProcedure or surgery
the treatment is the same as usual in our center
assessment of symptoms after four monthsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | assessment of symptoms at the first medical examination; standard care protocol; pelvic floor physiotherapy; assessment of symptoms after four months Receives: 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 |
| Group B | Experimental | assessment of symptoms at the first medical examination; standard care protocol; assessment of symptoms after four months Receives: Diagnostic Test: assessment of symptoms at the first medical examination; Procedure: standard care protocol; Diagnostic Test: assessment of symptoms after four months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)).
Measured: 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)).
Measured: 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).
Measured: After four months from the randomization
Secondary outcomes (2)
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).
Measured: 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.
Measured: After 1, 3, 5, 8, 11 weeks from the randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start15 Jun 2018
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mabrouk, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572075
- Sponsor's protocol ID
- 345/2017/O/Sper
- Acronym
- endofisio-01
- Status last verified
- Jun 2019
- First submitted
- 27 May 2018
- Last updated
- 12 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Pelvic Floor Physiotherapy in Symptomatic Patients Affected by Deep Infiltrating Endometriosis
- ClinicalTrials.gov ID
- NCT03572075
- Acronym / sponsor ID
- endofisio-01 / 345/2017/O/Sper
- Conditions
- Endometriosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 28 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | 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 monthsassessment of symptoms at the first medical examination; standard care protocol; pelvic floor physiotherapy; assessment of symptoms after four months |
| Group B | Experimental | Diagnostic Test: assessment of symptoms at the first medical examination, Procedure: standard care protocol, Diagnostic Test: assessment of symptoms after four monthsassessment of symptoms at the first medical examination; standard care protocol; assessment of symptoms after four months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with clinical and ultrasound diagnosis of deep endometriosis with related symptoms (chronic pelvic pain, dysmenorrhea, dyschezia, dyspareunia, dysuria)
- Nulliparity
- Obtaining Informed Consent
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment of symptoms at the first medical examinationassessment 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 | Diagnostic test | Group A, Group B |
| pelvic floor physiotherapysix 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 or surgery | Group A |
| standard care protocolthe treatment is the same as usual in our center | Procedure or surgery | Group A, Group B |
| assessment of symptoms after four monthsassessment 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. | Diagnostic test | Group A, Group B |
Primary outcome
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)).
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).
2 secondary outcomes
Evaluation of uro-genital hiatus using 3D-4D transperineal ultrasound
Time frame: At randomization and after four months from the randomization
Evaluation of the 3D-4D transperineal ultrasound as a bio-feedback tool
Time frame: After 1, 3, 5, 8, 11 weeks from the randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assessment of symptoms at the first medical examination, pelvic floor physiotherapy and assessment of symptoms after four months in people with Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simona Del Forno, MD (00393288948806, simona.delforno2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the impact of pelvic floor physiotherapy on intestinal function (time frame: After four months from the randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.