Questionnaire of Lower Urinary Tract Symptoms Among Women Before and After Surgical Correction of Uterine Prolapse

Recruiting

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT06260436
• Lead Sponsor: Assiut University

Brief Summary

. The study will include patients who underwent Pelvic reconstructive surgery for advanced pelvic organ prolapse (POP-Q ≥ 3). Data regarding preoperative evaluation, surgical procedure, and post-operative management will be collected. women will receive a follow up questionnaire. . The baseline questionnaire included data on age, urinary incontinence, daytime frequency, nocturia, postmicturition dribble, straining, urgency, incomplete bladder emptying, and hesitancy. Women were asked about leakage caused by coughing or sneezing, moving, lifting, sleeping, sexual intercourse, urgency, and rest.

Detailed Description

Pelvic organs prolapse (POP) is defined as the downward descent of the pelvic organs resulting in protrusion of the vagina and/or uterine cervix. POP and overactive bladder (OAB) often co-exist. The International Continence Society defines OAB as "urgency with or without urge incontinence, usually with frequency and nocturia" Of women with symptomatic pelvic organ prolapse, 13-39% experience voiding dysfunction (VD).

The aim of the study is to determine the effect of prolapse surgery on voiding function. The study will include patients who underwent Pelvic reconstructive surgery for advanced pelvic organ prolapse (POP-Q ≥ 3). Data regarding preoperative evaluation, surgical procedure, and post-operative management will be collected. women will receive a follow up questionnaire.

Non-responders will send a reminder after three weeks and if the non-responders still failed to respond were eventually asked to complete a short form comprising questions on urgency and incontinence. This procedure followed guidelines outlined by the local ethical committee. The baseline questionnaire included data on age, urinary incontinence, daytime frequency, nocturia, postmicturition dribble, straining, urgency, incomplete bladder emptying, and hesitancy. Women were asked about leakage caused by coughing or sneezing, moving, lifting, sleeping, sexual intercourse, urgency, and rest. stress incontinence according to the International Continence Society defined as leakage caused by exertion (coughing or sneezing, moving, or lifting) and urge incontinence as leakage associated with urgency.

Study Timeline

• Study Start: 2021-05-30
• Status Verified: 2024-02
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

1. Age; greater than or equal to 18 years
2. women with urogenital prolapse grade 3 or more
3. indicated for surgical repair for pelvic organ prolapse
4. Willing and able to sign an informed consent
5. Willing to comply with the study protocol

Exclusion Criteria

1. Anti-incontinence surgery
2. Lower urinary tract anomaly
3. Active urinary tract infections
4. Bladder tumor.
5. Bladder stones

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
effect of surgical correction of pelvic organ prolapse on the lower urinary tract symptoms	3 months	the effect of surgical correction of pelvic organ prolapse on the lower urinary tract symptoms will be checked through a validated questionnaire before and after surgical correction

Secondary Outcome Measures

Name	Time	Method
effect of surgical correction of pelvic organ prolapse on the quality of life	3 months	the questionnaire will check the effect of surgical correction of pelvic organ prolapse on quality of life

Trial Locations

Locations (1)

Assuit University; 🇪🇬 Assiut, Assuit, Egypt