ProlapseNCT03400007
Clinical and Dynamic Floor MRI Evaluation Before and After Prolapse Surgery
An observational study of Prolapse, run by Tatiana Besse-Hammer at 2 sites in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolapse
- What is being tested?
- Dynamic floor magnetic resonance imaging and Colpocystodefecography
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Nov 2017to 26 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients who will undergo internal or external rectal prolapse, enterocele or urogenital prolapse surgery in CHU Brugmann and CHU St Pierre.
Who cannot join
- MRI contra-indications
- Patients with prior pelvic floor surgery
Trial locations and contacts
2 sites in 1 country.
About this study
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.
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.
Read more
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
- Being tested
- Dynamic floor magnetic resonance imaging, Colpocystodefecography
- Keywords
- dynamic floor magnetic resonance imaging, colpocystodefecagraphy, prolapse surgery
- Medical subject headings
- Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic floor magnetic resonance imagingDevice
Dynamic floor magnetic resonance imaging (MRI)
ColpocystodefecographyDevice
Colpocystodefecography (CCD)
| Study group | Role | What they receive |
|---|---|---|
| Prolapse surgery | Not described Receives: Device: Dynamic floor magnetic resonance imaging; Device: Colpocystodefecography |
What is being measured
The primary outcome is the main question the study is designed to answer.
recto-anal angle -relax position
Measured by dynamic floor MRI in left lateral decubitus position (141°)
Measured: 6 months post surgery
recto-anal angle -retain position
Measured by dynamic floor MRI in left lateral decubitus position (163°)
Measured: 6 months post surgery
recto-anal angle -push position
Measured by dynamic floor MRI in left lateral decubitus position (165°)
Measured: 6 months post surgery
recto-anal angle -relax position
Measured by dynamic floor MRI in sitting position (141°)
Measured: 6 months post surgery
recto-anal angle -retain position
Measured by dynamic floor MRI in sitting position (125°)
Measured: 6 months post surgery
recto-anal angle -push position
Measured by dynamic floor MRI in sitting position (143°)
Measured: 6 months post surgery
Dynamic MRI: anterior compartment
From the bladder, discrete inferior descent of the pubococcygeal line: max 1/3 (yes/no)
Measured: 6 months post surgery
Dynamic MRI: medium compartment
Vagina horizontalization (yes/no)
Measured: 6 months post surgery
Secondary outcomes (5)
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.
Measured: 6 months post surgery
Constipation scoring system (CCS)
Validated questionnaire. Minimum Score, 0 - Maximum Score, 30
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Nov 2017
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tatiana Besse-Hammer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tatiana Besse-Hammer, Brugmann University Hospital
- Investigators
- Katleen Jottard, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400007
- Sponsor's protocol ID
- CHUB-prolapse
- Status last verified
- Jul 2022
- First submitted
- 9 Jan 2018
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03400007
- Acronym / sponsor ID
- CHUB-prolapse
- Conditions
- Prolapse
- Keywords
- dynamic floor magnetic resonance imaging, colpocystodefecagraphy, prolapse surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Tatiana Besse-HammerUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prolapse surgery | – | Device: Dynamic floor magnetic resonance imaging, Device: Colpocystodefecography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients who will undergo internal or external rectal prolapse, enterocele or urogenital prolapse surgery in CHU Brugmann and CHU St Pierre.
Key exclusion criteria (2 listed)
- MRI contra-indications
- Patients with prior pelvic floor surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic floor magnetic resonance imagingDynamic floor magnetic resonance imaging (MRI) | Device | Prolapse surgery |
| ColpocystodefecographyColpocystodefecography (CCD) | Device | Prolapse surgery |
Primary outcome
recto-anal angle -relax position
Time frame: 6 months post surgery
Measured by dynamic floor MRI in left lateral decubitus position (141°)
recto-anal angle -retain position
Time frame: 6 months post surgery
Measured by dynamic floor MRI in left lateral decubitus position (163°)
recto-anal angle -push position
Time frame: 6 months post surgery
Measured by dynamic floor MRI in left lateral decubitus position (165°)
recto-anal angle -relax position
Time frame: 6 months post surgery
Measured by dynamic floor MRI in sitting position (141°)
recto-anal angle -retain position
Time frame: 6 months post surgery
Measured by dynamic floor MRI in sitting position (125°)
recto-anal angle -push position
Time frame: 6 months post surgery
Measured by dynamic floor MRI in sitting position (143°)
Dynamic MRI: anterior compartment
Time frame: 6 months post surgery
From the bladder, discrete inferior descent of the pubococcygeal line: max 1/3 (yes/no)
Dynamic MRI: medium compartment
Time frame: 6 months post surgery
Vagina horizontalization (yes/no)
5 secondary outcomes
Fecal Incontinence Severity Index (FISI)
Time frame: 6 months post surgery
Constipation scoring system (CCS)
Time frame: 6 months post surgery
Prolapse Quality of Life (P-QOL) questionnaire
Time frame: 6 months post surgery
Sexual function questionnaire (PISQ-IR)
Time frame: 6 months post surgery
Visual analogic Scale (VAS)
Time frame: 6 months post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katleen Jottard, MD principal investigator
CHU Brugmann
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolapse, run by Tatiana Besse-Hammer at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recto-anal angle -relax position (time frame: 6 months post surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.