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

NCT ID: NCT06260436

Last Updated: 2024-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-30

Study Completion Date

2024-12-30

Brief Summary

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. 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

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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.

Conditions

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Pelvic Organ Prolapse

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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pelvic organ prolapse patients with lower urinary tract symptoms

this group for patient who have pelvic organ prolapse and lower urinary tract symptoms

No interventions assigned to this group

pelvic organ prolapse patients without lower urinary tract symptoms

this group for patient who have pelvic organ prolapse but do not have any lower urinary tract symptoms

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Tharwat Gamal Mohammed Ibrahim

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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tharwat gm mohamed

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Mustafa mb bahlool, professor

Role: STUDY_DIRECTOR

Assiut University

Locations

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Assuit University

Asyut, Assuit, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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tharwat gl mohammed

Role: CONTACT

01151166826

tharwat gl mohamed

Role: CONTACT

01151166826

Facility Contacts

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tharwat gl mohamed

Role: primary

01151166826

tht tg mohamed

Role: backup

01017941889

References

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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.

Reference Type RESULT
PMID: 18958382 (View on PubMed)

Other Identifiers

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Tharwat gamal Mohamed

Identifier Type: -

Identifier Source: org_study_id

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