Clinical and Dynamic Floor MRI Evaluation Before and After Prolapse Surgery

Sponsor
Tatiana Besse-Hammer (Other)
Overall Status
Completed
CT.gov ID
NCT03400007
Collaborator
(none)
34
2
47.8
17
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Dynamic floor magnetic resonance imaging
  • Device: Colpocystodefecography

Study Design

Study Type:
Observational
Actual Enrollment :
34 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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.
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Oct 26, 2021
Actual Study Completion Date :
Oct 26, 2021

Arms and Interventions

Arm Intervention/Treatment
Prolapse surgery

Device: Dynamic floor magnetic resonance imaging
Dynamic floor magnetic resonance imaging (MRI)

Device: Colpocystodefecography
Colpocystodefecography (CCD)

Outcome Measures

Primary Outcome Measures

  1. recto-anal angle -relax position [6 months post surgery]

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

  2. recto-anal angle -retain position [6 months post surgery]

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

  3. recto-anal angle -push position [6 months post surgery]

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

  4. recto-anal angle -relax position [6 months post surgery]

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

  5. recto-anal angle -retain position [6 months post surgery]

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

  6. recto-anal angle -push position [6 months post surgery]

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

  7. Dynamic MRI: anterior compartment [6 months post surgery]

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

  8. Dynamic MRI: medium compartment [6 months post surgery]

    Vagina horizontalization (yes/no)

Secondary Outcome Measures

  1. 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.

  2. Constipation scoring system (CCS) [6 months post surgery]

    Validated questionnaire. Minimum Score, 0 - Maximum Score, 30

  3. 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.

  4. 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.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU St Pierre Brussels Belgium
2 CHU Brugmann Brussel Belgium 1020

Sponsors and Collaborators

  • Tatiana Besse-Hammer

Investigators

  • Principal Investigator: Katleen Jottard, MD, CHU Brugmann

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tatiana Besse-Hammer, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier:
NCT03400007
Other Study ID Numbers:
  • CHUB-prolapse
First Posted:
Jan 17, 2018
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tatiana Besse-Hammer, Head of clinic, Brugmann University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022