Is Preoperative Urodynamics Essential for Women With Pelvic Organ Prolapse (urodynaemics)

Is Urodynamic Study an Essential Step in Preoperative Evaluation of Women With Pelvic Organ Prolapse With Urinary Tract Dysfunction: Prospective Comparative Study

urodynamic investigation when added in the diagnostic work-up of women with lower urinary tract dysfunction with POP is debatable.

This study was planned to determine the usefulness of preoperative urodynamic study in improving urological outcome following surgery in women with pelvic organ prolapse and urinary tract dysfunction.

Study Overview

• Status: Completed
• Conditions: Urogenital Prolapse
• Intervention / Treatment: Diagnostic test: urodynaemic studies

Detailed Description

60 patients, fulfilled the selection criteria were counseled and informed about the trial protocol and a written consent according to declaration of Helsinki was signed. Participants were randomly assigned following simple randomization procedures (computerized random numbers) to group (1) or group (2). Each group consisted of 30 patients. All participants had been thoroughly evaluated by history and examination. A standardized questionnaire was obtained to evaluate the symptoms of stress urinary incontinence, urge urinary incontinence and obstructive symptoms. Clinical staging of pelvic organ prolapse by POP Q Staging. Ultrasound examination had been also carried out to rule out any pelvic pathology. Patients had completed a 3-day bladder diary (frequency volume chart) to assist in arriving at an urodynamic diagnosis. Urinalysis was performed. Only patients allocated for group 1 were subjected to urodynamic studies before surgical intervention and then corrective procedures for POP had been done .The Urodynamic studies carried out were : uroflowmetry and cystometry. The Uroflowmetry was performed by the gravimeter method, where maximum flow rate, average flow rate, voided volume and residual urine was measured. Maximum flow rate ≤15 ml/sec, and/or residual urine of more than 50 ml or 10% of voided volume in a bladder filled with a minimum of 150 ml was taken as cut off to detect abnormal voiding. Cystometric parameters which indicated normal bladder function were first desire to void between 150 and 200 ml, capacity (taken as strong desire to void) of greater than 400 ml, detrusor pressure rise on filling of less than 15 mm H2O per 500 ml infused, absence of detrusor contractions, no leakage on coughing, no significant pain on filling and finally a detrusor pressure rises on voiding (maximum voiding pressure) of less than 50 cm H2O, with a peak flow rate of more than 15 ml/s for a voided volume over 150 ml. Urodynamic stress incontinence was diagnosed when urethral leakage was seen with increased abdominal pressure, in the absence of detrusor contractions. Detrusor over activity was diagnosed when the patient has involuntary detrusor contractions during filling with or without leakage which may be spontaneous or provoked. All participants were followed-up with same questionnaire and clinical examination after 12 weeks post operatively.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • El-Khartoum Square
    • Alexandria, El-Khartoum Square, Egypt, 21131
      • Shatby maternity university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

performed in Shatby Maternity University hospital, which is considered the largest hospital in Alexandria city in Egypt offering obstetrical and gynecological services for more than three millions females

Description

Inclusion Criteria:

- pelvic organ prolapse associated with lower urinary tract dysfunction.

Exclusion Criteria:

• are those who had previous surgery for urinary incontinence, or experienced neurological disorder such as multiple sclerosis or spinal cord injuries were not included. Or had complicated medical disease that made the patient unfit for anesthesia.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
(1) URODYNAEMICS GROUP; 30 patients allocated for group (1) had been thoroughly evaluated by history and examination. A standardized questionnaire was obtained to evaluate the symptoms of stress urinary incontinence, urge urinary incontinence and obstructive symptoms. Clinical staging of pelvic organ prolapse by POP Q Staging .Ultrasound examination had been also carried out to rule out any pelvic pathology. Patients had completed a 3-day bladder diary (frequency volume chart) to assist in arriving at an urodynamic diagnosis. Urinalysis was performed. And to urodynamic studies were performed before surgical intervention and then corrective procedures for POP had been done uroflowmetry and cystometry. All participants were followed-up with same questionnaire and clinical examination after 12 weeks post -operatively	Diagnostic test: urodynaemic studies; The Urodynamic studies carried out were : uroflowmetry and cystometry. The Uroflowmetry was performed by the gravimetric method Detrusor over activity was diagnosed when the patient has involuntary detrusor contractions during filling with or without leakage which may be spontaneous or provoked,
(2)NON URODYNAMICS GROUP; 30 patients allocated for group (2) had been thoroughly evaluated by history and examination. A standardized questionnaire was obtained to evaluate the symptoms of stress urinary incontinence, urge urinary incontinence and obstructive symptoms. Clinical staging of pelvic organ prolapse by POP Q Staging .Ultrasound examination had been also carried out to rule out any pelvic pathology. Patients had completed a 3-day bladder diary (frequency volume chart) to assist in arriving at an urodynamic diagnosis. Urinalysis was performed and then corrective procedures for POP had been done.All participants were followed-up with same questionnaire and clinical examination after 12 weeks post-- operatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urological outcome following surgery in women with pelvic organ prolapse and urinary tract dysfunction.	persistence of urinary incontinence	3months

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Mervat AM Elsersy, MD, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2020
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: July 18, 2021
• First Submitted That Met QC Criteria: July 18, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: July 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Urodynamics; pelvic organ prolapse,
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 0304824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all individual participant data that underlie results in a publication
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: Researcher of the same institution
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No