NCT03572075

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

1.2 years

First QC Date

May 27, 2018

Last Update Submit

June 11, 2019

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Evaluation of uro-genital hiatus using 3D-4D transperineal ultrasound

    At randomization and after four months from the randomization

  • Evaluation of the 3D-4D transperineal ultrasound as a bio-feedback tool

    After 1, 3, 5, 8, 11 weeks from the randomization

Study Arms (2)

Group A

EXPERIMENTAL

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 examinationProcedure: pelvic floor physiotherapyProcedure: standard care protocolDiagnostic 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

Diagnostic Test: assessment of symptoms at the first medical examinationProcedure: standard care protocolDiagnostic Test: assessment of symptoms after four months

Interventions

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

Group AGroup B
pelvic floor physiotherapyPROCEDURE

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.

Group A
standard care protocolPROCEDURE

the treatment is the same as usual in our center

Group AGroup B
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.

Group AGroup B

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with clinical and ultrasound diagnosis of deep endometriosis with related symptoms (chronic pelvic pain, dysmenorrhea, dyschezia, dyspareunia, dysuria)
  • Nulliparity
  • Obtaining Informed Consent

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital

Bologna, BO, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Simona Del Forno, MD

CONTACT

00393288948806simona.delforno2@unibo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 27, 2018

First Posted

June 28, 2018

Study Start

June 15, 2018

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

June 12, 2019

Record last verified: 2019-06

Locations

IT(1)