Effect of Bladder Filling on Rectal Contractions During Cystometry

NCT05013541 | Completed

• 1 other identifier: GREENGRC01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bladder Dysfunction

Keywords

urodynamics; rectum / physiopathology; muscle contraction / physiology

Outcome Measures

Primary Outcomes (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)

  One day

Secondary Outcomes (6)

• Variation of the amplitude of rectal contraction function of bladder sensation 2

  one day

• Variation of the amplitude of rectal contraction function of bladder sensation 3

  One day

• Variation of the amplitude of rectal contraction function of bladder sensation 4

  One day

• Frequency of rectal contraction function of bladder sensation

  One day

• Variation of the amplitude of rectal contraction function of bladder filling

  One day

Study Arms (1)

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.

Other: No intervention

Interventions

No intervention OTHER

Observational study, standard record of need to void during cystometry

Patients included

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

observational cohort of included patients

You may qualify if:

• age over 18
• lower urinary tract dysfunction requiring cystometry assessement
• rectal contraction during cystometry

You may not qualify if:

• Colo-rectal inflammatory or oncological disease
• History of colo-rectal surgery
• Irritable bowel syndrome
• Probe expulsion (during urodynamic study).

Sponsors & Collaborators

• Gérard Amarenco: lead

Study Sites (1)

department of Neuro-Urology, Hôpital Teno

Paris, 75020, France

Location

Study Officials

• Gérard Amarenco, PUPH

  Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Neuro-Urology department, Tenon Hospital

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 19, 2021
• Study Start: March 10, 2021
• Primary Completion: August 31, 2021
• Study Completion: September 30, 2021
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

FR (1)