Clinical and Dynamic Floor MRI Evaluation Before and After Prolapse Surgery

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.

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.

Study Overview

• Status: Completed
• Conditions: Prolapse
• Intervention / Treatment: Device: Dynamic floor magnetic resonance imaging; Device: Colpocystodefecography

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1020
    • CHU Brugmann
  • Brussels, Belgium
    • Chu St Pierre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prolapse surgery	Device: Dynamic floor magnetic resonance imaging; Dynamic floor magnetic resonance imaging (MRI); Device: Colpocystodefecography; Colpocystodefecography (CCD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal Incontinence Severity Index (FISI)	This is a health tool that describes the severity of different types of incontinence for bowel contents.There are 4 items in the FISI scale with 6 answer choices. Points are awarded according to the gravity of the symptoms. The higher the FISI index (which ranges from 0 to 61), the higher the severity of the fecal incontinence.	6 months post surgery
Constipation scoring system (CCS)	Validated questionnaire. Minimum Score, 0 - Maximum Score, 30	6 months post surgery
Prolapse Quality of Life (P-QOL) questionnaire	Validated questionnaire covering nine domains: general health (1 item), prolapse impact (1 item), role (2 items), physical (2 items) and social limitations (3 items), personal relationships (2 items), emotions (3 items), sleep/energy (2 items), and severity measurement (4 items). The answers are categorized using a fourpoint Likert scale: "none/not at all," "slightly/a little," "moderately," and "a lot." A score is calculated for each domain ranging from 0 to 100. A higher score indicates a greater impairment of quality of life.	6 months post surgery
Sexual function questionnaire (PISQ-IR)	Validated questionnaire. The PISQ-12 measures three domains: behavioral-emotive (items 1 - 4), physical (items 5 - 9) and partner-related (items 10 - 12). It is a self-administered questionnaire, and responses are graded on a five-point Likert scale ranging from 0 (always) to 4 (never). Items 1 - 4 are reversely scored and a total of 48 is the maximum score. Higher scores indicate better sexual function.	6 months post surgery
Visual analogic Scale (VAS)	The VAS scale (EVA in French) is a straight line of 100 mn length. One end is the absence of pain, the other end represents unbearable pain. The patient places a mark between these 2 extremities according to the intensity of his pain at a given time.	6 months post surgery

Collaborators and Investigators

• Sponsor: Tatiana Besse-Hammer
• Investigators: Principal Investigator: Katleen Jottard, MD, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): October 26, 2021
• Study Completion (Actual): October 26, 2021

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: prolapse surgery; dynamic floor magnetic resonance imaging; colpocystodefecagraphy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: CHUB-prolapse

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No