Clinical and Dynamic Floor MRI Evaluation Before and After Prolapse Surgery

NCT03400007 | Completed

• 1 other identifier: CHUB-prolapse
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Prolapse

Keywords

dynamic floor magnetic resonance imaging; colpocystodefecagraphy; prolapse surgery

Outcome Measures

Primary Outcomes (8)

• recto-anal angle -relax position

  Measured by dynamic floor MRI in left lateral decubitus position (141°)

  6 months post surgery

• recto-anal angle -retain position

  Measured by dynamic floor MRI in left lateral decubitus position (163°)

  6 months post surgery

• recto-anal angle -push position

  Measured by dynamic floor MRI in left lateral decubitus position (165°)

  6 months post surgery

• recto-anal angle -relax position

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

  6 months post surgery

• recto-anal angle -retain position

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

  6 months post surgery

• recto-anal angle -push position

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

  6 months post surgery

• Dynamic MRI: anterior compartment

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

  6 months post surgery

• Dynamic MRI: medium compartment

  Vagina horizontalization (yes/no)

  6 months post surgery

Secondary Outcomes (5)

• 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

• Sexual function questionnaire (PISQ-IR)

  6 months post surgery

• Visual analogic Scale (VAS)

  6 months post surgery

Study Arms (1)

Prolapse surgery

Device: Dynamic floor magnetic resonance imaging; Device: Colpocystodefecography

Interventions

Dynamic floor magnetic resonance imaging DEVICE

Dynamic floor magnetic resonance imaging (MRI)

Prolapse surgery

Colpocystodefecography DEVICE

Colpocystodefecography (CCD)

Prolapse surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who will be operated for symptomatic rectal intussusception or prolapse, enterocele and/or urogenital prolapse, though abdominal and persineal approach as well.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tatiana Besse-Hammer: lead

Study Sites (2)

CHU Brugmann

Brussels, 1020, Belgium

Location

CHU St Pierre

Brussels, Belgium

Location

MeSH Terms

Conditions

Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Katleen Jottard, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: November 1, 2017
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)