Bladder DysfunctionNCT05013541
Effect of Bladder Filling on Rectal Contractions During Cystometry
An observational study of Bladder Dysfunction, run by Gérard Amarenco at 1 site in France.
Trial summary
Increasing knowledge on rectal motility and bladder-rectum cross-talk has been published in recent years. However, whether bladder filling factors during multichannel urodynamic studies affect rectal contraction (RC) parameters has not been studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Dysfunction
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2021to 30 Sep 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: observational cohort of included patients
Who may be able to join
- age over 18
- lower urinary tract dysfunction requiring cystometry assessement
- rectal contraction during cystometry
Who cannot join
- Colo-rectal inflammatory or oncological disease
- History of colo-rectal surgery
- Irritable bowel syndrome
- Probe expulsion (during urodynamic study).
Trial locations and contacts
1 site in 1 country.
About this study
Increasing knowledge on rectal motility and bladder-rectum cross-talk has been published in recent years. However, whether bladder filling factors during multichannel urodynamic studies affect rectal contraction (RC) parameters has not been studied.
The primary aim of this study is to assess the impact of bladder filling and desire to void on rectal contraction amplitude or frequency.
Read more
Secondary objectives are to determine any significant change in rectal parameters depending on clinical and urodynamic factors or treatment.
All patients referred for urodynamic assessment and with studies positive for rectal contractions as defined by the international continence society (ICS) will be included. Abdominal pressure will be measured using a T-doc air charged abdominal catheter inserted 10 cm from the anal margin. Standardized urodynamic evaluation will be conducted following ICS guidelines.
Mean amplitude, maximal amplitude (cmH20) and mean frequency of rectal contractions on all urodynamic studies will be visually measured on the recording software and compared depending on bladder sensation (First Desire to void (FDV), Strong Desire to Void (SDV) and filling volume (200ml, 400ml).
Demographic data (age, sex, BMI), underlying neurological disease, clinical symptoms, and scores (Neurogenic Bladder Symptom Score, Bristol Score, Cleveland Score), urodynamic parameters and treatments will be collected. Time since last defecation and meal will also be collected.
This prospective observational study will be conducted in a Neuro-Urology department of a French university hospital. All the patients included are referred for multichannel urodynamic assessment.
Read the detailed description
Studies have suggested multiple types of colonic motor patterns including rectal motor activity. This rectal activity has been described in conventional multichannel urodynamic studies and has been determined not be an artefact. Some studies have related this rectal activity to bladder dysfunction, an underlying neurological affection or old ageing. However, the significance of this rectal activity observed during urodynamic studies remains unclear. It has been suggested that rectal activity may be a marker for underlying conditions.
On the other hand, rectal phasic contractions using conventional manometry have been described for decades and consecutively coined rectal motor activity, periodic rectal motor activity and rectal motor complex. Recent data using High Resolution Manometry reports retrograde propagating cyclic motor patterns occurring with a frequency of 2 to 6 events per minute. In this study 59% of retrograde CMPs initiated in the sigmoid colon and rectum in the postprandial period suggesting a mechanism to limit rectal filling. This supports Rao and al.'s theory of a rectosigmoid brake. Modifications of CMP have also been shown in pathology such as slow transit constipation and fecal incontinence although results are conflicting.
Furthermore, rectum and bladder share a common embryological origin and innervation which has led in recent years to the development of the concept of a cross talk between rectum and bladder. Animal and human studies have assessed the effect of rectal distension on bladder sensation and motility. However, whether bladder filling factors affect rectal contraction parameters has not been specifically studied.
The primary aim of this study is to assess if bladder sensation and filling volume have any significant effect on rectal contraction parameters such as amplitude or frequency. Secondary objectives are to determine any significant change in rectal parameters depending on clinical and urodynamic factors or treatment.
This prospective observational study will be conducted in a Neuro-Urology department of a French university hospital. All the patients included are referred for multichannel urodynamic assessment to explore urinary disorders.
All patients referred for urodynamic assessment will be screened. All patients with a recording of rectal contractions as defined by the international continence society (ICS) during the urodynamic study will be included. Rectal contraction identified by a first investigator will have to be confirmed by a second investigator to be included for further analysis. The ICS defines rectal contractions as: temporary phasic increases in abdominal pressure without synchronous change in vesical pressure resulting in negative deflections of detrusor pressure. Based on previously published studies, rectal contractions resulting in a more than 5 cmH20 change of abdominal pressure will be included for analysis. Abdominal pressure will be measured using a T-doc air charged abdominal catheter inserted 10 cm from the anal margin. Patients will be informed on the procedure prior to the exam. Filling of the bladder will be carried out in a semi-seated position. Patients will be asked to report need to void; FSF, First Desire to Void (FDV) and SDV.
The following data will be collected: age, sex, body mass index, etiology of urinary disorders, type of urinary or bowel symptoms, use of treatment for urinary or bowel dysfunction, time of last meal, detrusor overactivity on urodynamics.
Amplitude and frequency of rectal contractions will be measured individually on the software used for the urodynamic study. The amplitude of each contraction will be measured as the difference between the peak of the contraction wave and the baseline preceding each contraction. Mean and maximum amplitude will be compared between time samples depending on bladder sensation and filling volume. The frequency will be calculate as (number of contraction on the studied period)/(time of the studied period). Absence of contraction on a sample will be counted as a frequency of 0. The occurrence of at least 2 contractions over a time sample will be necessary in order for an average frequency to be calculated. Frequency of contractions will be compared between beginning of cystometry to first desire to void (FDV) and FDV to end of bladder filling.
Secondary analysis to assess the impact of clinical and urodynamic data on rectal contraction parameters will be performed.
All data will be collected and analyzed without any identifying information.
- Conditions
- Bladder Dysfunction
- Being tested
- No intervention
- Keywords
- urodynamics, rectum / physiopathology, muscle contraction / physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational study, standard record of need to void during cystometry
| Study group | Role | What they receive |
|---|---|---|
| Patients included | Patients with lower urinary tract disorders assessed with multichannel cystometry and presence of rectal contractions.
Measure of amplitude and frequency of rectal contractions function of the bladder sensation and volume of bladder filling. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the amplitude of rectal contraction function of bladder sensation 1
Difference of mean amplitude of rectal contraction between beginning of cystometry to first desire to void (FDV) and FDV to end of bladder filling (maximal capacity)
Measured: One day
Secondary outcomes (6)
Variation of the amplitude of rectal contraction function of bladder sensation 2
Difference of mean amplitude of rectal contraction between beginning of cystometry to first desire to void (FDV) and FDV to Strong Desire to Void (SDV)
Measured: one day
Variation of the amplitude of rectal contraction function of bladder sensation 3
Difference of maximal amplitude of rectal contraction between beginning of cystometry to first desire to void (FDV) and FDV to end of bladder filling (maximal capacity)
Measured: One day
Variation of the amplitude of rectal contraction function of bladder sensation 4
Difference of maximal amplitude of rectal contraction between beginning of cystometry to first desire to void (FDV) and FDV to Strong Desire to Void (SDV)
Measured: One day
Frequency of rectal contraction function of bladder sensation
Difference of mean frequency of rectal contraction between beginning of cystometry to first desire to void (FDV) and FDV to end of bladder filling
Measured: One day
Variation of the amplitude of rectal contraction function of bladder filling
Difference of mean amplitude of rectal contraction between beginning of cystometry to 200mL of bladder filling and 200 to 400mL of bladder filling (maximal capacity)
Measured: One day
Rectal contraction parameters function of patients' characteristics
Difference of rectal contraction parameters (Mean amplitude, maximal amplitude and frequency) depending on demographic data (age, sex, BMI), underlying neurological disease, clinical symptoms, urodynamic status and treatments.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start10 Mar 2021
- Primary completion31 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder DysfunctionStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gérard Amarenco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gérard Amarenco, Pierre and Marie Curie University
- Investigators
- Gérard Amarenco, PUPH, Principal investigator, Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013541
- Sponsor's protocol ID
- GREENGRC01
- Status last verified
- Feb 2022
- First submitted
- 16 Aug 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bladder Filling on Rectal Contractions During Cystometry
- ClinicalTrials.gov ID
- NCT05013541
- Acronym / sponsor ID
- GREENGRC01
- Conditions
- Bladder Dysfunction
- Keywords
- urodynamics, rectum / physiopathology, muscle contraction / physiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gérard AmarencoUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 19 Aug 2021 (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.
Increasing knowledge on rectal motility and bladder-rectum cross-talk has been published in recent years. However, whether bladder filling factors during multichannel urodynamic studies affect rectal contraction (RC) parameters has not been studied.
The primary aim of this study is to assess the impact of bladder filling and desire to void on rectal contraction amplitude or frequency.
Secondary objectives are to determine any significant change in rectal parameters depending on clinical and urodynamic factors or treatment.
All patients referred for urodynamic assessment and with studies positive for rectal contractions as defined by the international continence society (ICS) will be included. Abdominal pressure will be measured using a T-doc air charged abdominal catheter inserted 10 cm from the anal margin. Standardized urodynamic evaluation will be conducted following ICS guidelines.
Mean amplitude, maximal amplitude (cmH20) and mean frequency of rectal contractions on all urodynamic studies will be visually measured on the recording software and compared depending on bladder sensation (First Desire to void (FDV), Strong Desire to Void (SDV) and filling volume (200ml, 400ml).
Demographic data (age, sex, BMI), underlying neurological disease, clinical symptoms, and scores (Neurogenic Bladder Symptom Score, Bristol Score, Cleveland Score), urodynamic parameters and treatments will be collected. Time since last defecation and meal will also be collected.
This prospective observational study will be conducted in a Neuro-Urology department of a French university hospital. All the patients included are referred for multichannel urodynamic assessment.
Detailed description
Studies have suggested multiple types of colonic motor patterns including rectal motor activity. This rectal activity has been described in conventional multichannel urodynamic studies and has been determined not be an artefact. Some studies have related this rectal activity to bladder dysfunction, an underlying neurological affection or old ageing. However, the significance of this rectal activity observed during urodynamic studies remains unclear. It has been suggested that rectal activity may be a marker for underlying conditions.
On the other hand, rectal phasic contractions using conventional manometry have been described for decades and consecutively coined rectal motor activity, periodic rectal motor activity and rectal motor complex. Recent data using High Resolution Manometry reports retrograde propagating cyclic motor patterns occurring with a frequency of 2 to 6 events per minute. In this study 59% of retrograde CMPs initiated in the sigmoid colon and rectum in the postprandial period suggesting a mechanism to limit rectal filling. This supports Rao and al.'s theory of a rectosigmoid brake. Modifications of CMP have also been shown in pathology such as slow transit constipation and fecal incontinence although results are conflicting.
Furthermore, rectum and bladder share a common embryological origin and innervation which has led in recent years to the development of the concept of a cross talk between rectum and bladder. Animal and human studies have assessed the effect of rectal distension on bladder sensation and motility. However, whether bladder filling factors affect rectal contraction parameters has not been specifically studied.
The primary aim of this study is to assess if bladder sensation and filling volume have any significant effect on rectal contraction parameters such as amplitude or frequency. Secondary objectives are to determine any significant change in rectal parameters depending on clinical and urodynamic factors or treatment.
This prospective observational study will be conducted in a Neuro-Urology department of a French university hospital. All the patients included are referred for multichannel urodynamic assessment to explore urinary disorders.
All patients referred for urodynamic assessment will be screened. All patients with a recording of rectal contractions as defined by the international continence society (ICS) during the urodynamic study will be included. Rectal contraction identified by a first investigator will have to be confirmed by a second investigator to be included for further analysis. The ICS defines rectal contractions as: temporary phasic increases in abdominal pressure without synchronous change in vesical pressure resulting in negative deflections of detrusor pressure. Based on previously published studies, rectal contractions resulting in a more than 5 cmH20 change of abdominal pressure will be included for analysis. Abdominal pressure will be measured using a T-doc air charged abdominal catheter inserted 10 cm from the anal margin. Patients will be informed on the procedure prior to the exam. Filling of the bladder will be carried out in a semi-seated position. Patients will be asked to report need to void; FSF, First Desire to Void (FDV) and SDV.
The following data will be collected: age, sex, body mass index, etiology of urinary disorders, type of urinary or bowel symptoms, use of treatment for urinary or bowel dysfunction, time of last meal, detrusor overactivity on urodynamics.
Amplitude and frequency of rectal contractions will be measured individually on the software used for the urodynamic study. The amplitude of each contraction will be measured as the difference between the peak of the contraction wave and the baseline preceding each contraction. Mean and maximum amplitude will be compared between time samples depending on bladder sensation and filling volume. The frequency will be calculate as (number of contraction on the studied period)/(time of the studied period). Absence of contraction on a sample will be counted as a frequency of 0. The occurrence of at least 2 contractions over a time sample will be necessary in order for an average frequency to be calculated. Frequency of contractions will be compared between beginning of cystometry to first desire to void (FDV) and FDV to end of bladder filling.
Secondary analysis to assess the impact of clinical and urodynamic data on rectal contraction parameters will be performed.
All data will be collected and analyzed without any identifying information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients included | – | Other: No interventionPatients with lower urinary tract disorders assessed with multichannel cystometry and presence of rectal contractions. Measure of amplitude and frequency of rectal contractions function of the bladder sensation and volume of bladder filling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- observational cohort of included patients
Key inclusion criteria (3 listed)
- age over 18
- lower urinary tract dysfunction requiring cystometry assessement
- rectal contraction during cystometry
Key exclusion criteria (4 listed)
- Colo-rectal inflammatory or oncological disease
- History of colo-rectal surgery
- Irritable bowel syndrome
- Probe expulsion (during urodynamic study).
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 |
|---|---|---|
| No interventionObservational study, standard record of need to void during cystometry | Other | Patients included |
Primary outcome
Variation of the amplitude of rectal contraction function of bladder sensation 1
Time frame: One day
Difference of mean amplitude of rectal contraction between beginning of cystometry to first desire to void (FDV) and FDV to end of bladder filling (maximal capacity)
6 secondary outcomes
Variation of the amplitude of rectal contraction function of bladder sensation 2
Time frame: one day
Variation of the amplitude of rectal contraction function of bladder sensation 3
Time frame: One day
Variation of the amplitude of rectal contraction function of bladder sensation 4
Time frame: One day
Frequency of rectal contraction function of bladder sensation
Time frame: One day
Variation of the amplitude of rectal contraction function of bladder filling
Time frame: One day
Rectal contraction parameters function of patients' characteristics
Time frame: One day
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 18 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
Gérard Amarenco, PUPH principal investigator
Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Dysfunction, run by Gérard Amarenco at 1 site in France.
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 3 inclusion and 4 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 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Variation of the amplitude of rectal contraction function of bladder sensation 1 (time frame: One day). 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 18 Feb 2022.