Clinical and Dynamic Floor MRI Evaluation Before and After Prolapse Surgery

Completed

• Conditions: Prolapse
• Interventions: Device: Dynamic floor magnetic resonance imaging; Device: Colpocystodefecography

• Registration Number: NCT03400007
• Lead Sponsor: Tatiana Besse-Hammer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-17
• Primary Completion: 2021-10-26
• Study Completion: 2021-10-26
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prolapse surgery	Dynamic floor magnetic resonance imaging	-
Prolapse surgery	Colpocystodefecography	-

Primary Outcome Measures

Name	Time	Method
recto-anal angle -push position	6 months post surgery	Measured by dynamic floor MRI in sitting position (143°)
recto-anal angle -relax position	6 months post surgery	Measured by dynamic floor MRI in sitting position (141°)
recto-anal angle -retain position	6 months post surgery	Measured by dynamic floor MRI in sitting position (125°)
Dynamic MRI: medium compartment	6 months post surgery	Vagina horizontalization (yes/no)
Dynamic MRI: anterior compartment	6 months post surgery	From the bladder, discrete inferior descent of the pubococcygeal line: max 1/3 (yes/no)

Secondary Outcome Measures

Name	Time	Method
Fecal Incontinence Severity Index (FISI)	6 months post surgery	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.
Constipation scoring system (CCS)	6 months post surgery	Validated questionnaire. Minimum Score, 0 - Maximum Score, 30
Prolapse Quality of Life (P-QOL) questionnaire	6 months post surgery	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.
Visual analogic Scale (VAS)	6 months post surgery	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.
Sexual function questionnaire (PISQ-IR)	6 months post surgery	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.

Trial Locations

Locations (2)

CHU Brugmann; 🇧🇪 Brussel, Belgium

CHU St Pierre; 🇧🇪 Brussels, Belgium