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Clinical Trials/NCT03400007
NCT03400007
Completed
Not Applicable

Pre- and Postoperative Dynamic Floor MRI in Order to Evaluate the Anatomical and Functional Changes of the Different Pelvic Floor Organs, Before and After Prolapse Surgery.

Tatiana Besse-Hammer2 sites in 1 country34 target enrollmentNovember 1, 2017
ConditionsProlapse

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prolapse
Sponsor
Tatiana Besse-Hammer
Enrollment
34
Locations
2
Primary Endpoint
recto-anal angle -push position
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Pelvic organ prolapsed, associated with defecation disorders and urinary tracts symptoms are common and affect up to 25% of the population, mostly parous women. The pelvic floor must be seen as one entity, with multiple anatomical and physiological interactions between the various compartments (rectum, vagina, uterus and bladder) which are embedded in the same anatomical region. The often complex pathologies of this region should therefore be treated in a multidisciplinary setting.

Besides clinical evaluation, functional dynamic imaging of anorectal and pelvic floor disfunctions has an important role in the diagnosis and management of these disorders. Although the colpocystodefecography is still considered to be the golden standard in imaging this complex anatomical region, there is clearly a need for more precise imaging of the structural details, preferentially without any irradiation. Transperineal ultrasound is an option but the investigators have chosen to evaluate the use of dynamic magnetic resonance imaging. In contrast to colpocystodefecography, dynamic pelvic floor magnetic resonance imaging is an evolving technology and its precise role in functional imaging of the pelvic floor still remains to be determined.

Prolapse surgery is commonly performed and therefore it is important to assess the efficacy of the operations in correcting the anatomical defects and the symptoms associated without creating new, pelvic floor related symptoms. Few studies exist today allowing the assessment of the anatomical changes and symptoms after surgery, through abdominal or perineal approach.

This study will evaluate the reliability of the dynamic pelvic floor imaging, done in a sitting position, compared to colpocystodefecography, done in a sitting position. It will also compare clinical objective and subjective results related to pelvic floor abnormalities with imaging. Finally, it will evaluate the anatomical changes in correlation with the clinical results, organ position and inter-compartments relationships after surgery.

This study will allow to understand and explain some relapses and failures and could lead to an improvement of the indications for surgery and surgical techniques used.

Registry
clinicaltrials.gov
Start Date
November 1, 2017
End Date
October 26, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Tatiana Besse-Hammer
Responsible Party
Sponsor Investigator
Principal Investigator

Tatiana Besse-Hammer

Head of clinic

Brugmann University Hospital

Eligibility Criteria

Inclusion Criteria

  • All patients who will undergo internal or external rectal prolapse, enterocele or urogenital prolapse surgery in CHU Brugmann and CHU St Pierre.

Exclusion Criteria

  • MRI contra-indications
  • Patients with prior pelvic floor surgery

Outcomes

Primary Outcomes

recto-anal angle -push position

Time Frame: 6 months post surgery

Measured by dynamic floor MRI in sitting position (143°)

recto-anal angle -relax position

Time Frame: 6 months post surgery

Measured by dynamic floor MRI in sitting position (141°)

recto-anal angle -retain position

Time Frame: 6 months post surgery

Measured by dynamic floor MRI in sitting position (125°)

Dynamic MRI: medium compartment

Time Frame: 6 months post surgery

Vagina horizontalization (yes/no)

Dynamic MRI: anterior compartment

Time Frame: 6 months post surgery

From the bladder, discrete inferior descent of the pubococcygeal line: max 1/3 (yes/no)

Secondary Outcomes

  • Fecal Incontinence Severity Index (FISI)(6 months post surgery)
  • Constipation scoring system (CCS)(6 months post surgery)
  • Prolapse Quality of Life (P-QOL) questionnaire(6 months post surgery)
  • Visual analogic Scale (VAS)(6 months post surgery)
  • Sexual function questionnaire (PISQ-IR)(6 months post surgery)

Study Sites (2)

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