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

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06260436
• Other study ID #: Tharwat gamal Mohamed
• Status: Recruiting
• Start date: May 30, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: tharwat gl mohammed
• Phone: 01151166826
• Email: tharwat.fares3[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Pelvic Organ Prolapse
• Prolapse
• Uterine Prolapse

Locations

Country	Name	City	State
Egypt	Assuit University	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect of surgical correction of pelvic organ prolapse on the lower urinary tract symptoms	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	3 months
Secondary	effect of surgical correction of pelvic organ prolapse on the quality of life	the questionnaire will check the effect of surgical correction of pelvic organ prolapse on quality of life	3 months