An observational study in Urogenital Prolapse, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to female participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-06.
Sponsored by Alexandria University · Observational
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.
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.
676 studies on the registry are indexed under Prolapse; 79 are open to participants now.
This study's enrollment of 60 is below the median of 126 across 222 observational studies indexed under Prolapse.
Browse Prolapse studies →Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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
Exclusion Criteria:
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
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
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,
urological outcome following surgery in women with pelvic organ prolapse and urinary tract dysfunction.
persistence of urinary incontinence
Time frame: 3months
Plan to share: Yes — all individual participant data that underlie results in a publication
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Alexandria University