Clinical and Dynamic Floor MRI Evaluation Before and After Prolapse Surgery

Prolapse Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400007
• Other study ID #: CHUB-prolapse
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: October 26, 2021

Study information

• Verified date: July 2022
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 26, 2021
• Est. primary completion date: October 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prolapse

Intervention

Device:
• Dynamic floor magnetic resonance imaging
Dynamic floor magnetic resonance imaging (MRI)
• Colpocystodefecography
Colpocystodefecography (CCD)

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussel
Belgium	CHU St Pierre	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Tatiana Besse-Hammer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recto-anal angle -relax position	Measured by dynamic floor MRI in left lateral decubitus position (141°)	6 months post surgery
Primary	recto-anal angle -retain position	Measured by dynamic floor MRI in left lateral decubitus position (163°)	6 months post surgery
Primary	recto-anal angle -push position	Measured by dynamic floor MRI in left lateral decubitus position (165°)	6 months post surgery
Primary	recto-anal angle -relax position	Measured by dynamic floor MRI in sitting position (141°)	6 months post surgery
Primary	recto-anal angle -retain position	Measured by dynamic floor MRI in sitting position (125°)	6 months post surgery
Primary	recto-anal angle -push position	Measured by dynamic floor MRI in sitting position (143°)	6 months post surgery
Primary	Dynamic MRI: anterior compartment	From the bladder, discrete inferior descent of the pubococcygeal line: max 1/3 (yes/no)	6 months post surgery
Primary	Dynamic MRI: medium compartment	Vagina horizontalization (yes/no)	6 months post surgery
Secondary	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
Secondary	Constipation scoring system (CCS)	Validated questionnaire. Minimum Score, 0 - Maximum Score, 30	6 months post surgery
Secondary	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
Secondary	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
Secondary	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