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

A

Assiut University

Status

Enrolling

Conditions

Pelvic Organ Prolapse

Study type

Observational

Funder types

Other

Identifiers

NCT06260436
Tharwat gamal Mohamed

Details and patient eligibility

About

. 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.

Full 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.

Enrollment

180 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

180 participants in 2 patient groups

pelvic organ prolapse patients with lower urinary tract symptoms
Description:
this group for patient who have pelvic organ prolapse and lower urinary tract symptoms
pelvic organ prolapse patients without lower urinary tract symptoms
Description:
this group for patient who have pelvic organ prolapse but do not have any lower urinary tract symptoms

Trial contacts and locations

1

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Central trial contact

tharwat gl mohammed; tharwat gl mohamed

Data sourced from clinicaltrials.gov

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