Is Preoperative Urodynamics Essential for Women With Pelvic Organ Prolapse

NCT04980196 | Completed DMC

• 1 other identifier: 0304824
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urogenital Prolapse

Keywords

pelvic organ prolapse,; Urodynamics

Outcome Measures

Primary Outcomes (1)

• urological outcome following surgery in women with pelvic organ prolapse and urinary tract dysfunction.

  persistence of urinary incontinence

  3months

Study Arms (2)

(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

(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

Interventions

urodynaemic studies DIAGNOSTIC_TEST

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,

(1) URODYNAEMICS GROUP

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \- pelvic organ prolapse associated with lower urinary tract dysfunction.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Shatby Maternity University Hospital

Alexandria, El-Khartoum Square, 21131, Egypt

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mervat AM Elsersy, MD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: July 28, 2021
• Study Start: September 20, 2020
• Primary Completion: December 30, 2020
• Study Completion: May 1, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: Researcher of the same institution

Locations

EG (1)