Clinical trial NCT06260436: Questionnaire of Lower Urinary Tract Symptoms Among Women Before and After Surgical Correction of Uterine Prolapse
Official title: Questionnaire About The Incidence of Lower Urinary Tract Symptoms Among a Sample of Women Before and After Surgical Correction of Uterine Prolapse and Impact on Quality of Life
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Organ Prolapse
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: female cases at women health hospital at assuit 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.

Eligibility criteria: 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

Primary outcomes:
measure: effect of surgical correction of pelvic organ prolapse on the lower urinary tract symptoms
timeFrame: 3 months
Secondary outcomes:
measure: effect of surgical correction of pelvic organ prolapse on the quality of life
timeFrame: 3 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University
state: Assuit
Study officials:
affiliation: Assiut University
name: tharwat gm mohamed
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Mustafa mb bahlool, professor
role: STUDY_DIRECTOR
References:
citation: Baessler K, O'Neill SM, Maher CF, Battistutta D. Australian pelvic floor questionnaire: a validated interviewer-administered pelvic floor questionnaire for routine clinic and research. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Feb;20(2):149-58. doi: 10.1007/s00192-008-0742-4. Epub 2008 Oct 29.