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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • department of Neuro-Urology, Hôpital Teno

    Paris, 75020

Other trials in France

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.

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 groups in NCT05013541
Study groupRoleWhat they receive
Patients includedPatients 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted19 Aug 2021
  2. Study start10 Mar 2021
  3. Primary completion31 Aug 2021
  4. Study completion30 Sep 2021

Resources

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)
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

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.

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