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

NCT06260436 | Recruiting

• 1 other identifier: Tharwat gamal Mohamed
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• effect of surgical correction of pelvic organ prolapse on the quality of life

  3 months

Study Arms (2)

pelvic organ prolapse patients with lower urinary tract symptoms

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

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: only female cases will be eligible to participate
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

female cases at women health hospital at assuit university

You may qualify if:

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

You may not qualify if:

• Anti-incontinence surgery
• Lower urinary tract anomaly
• Active urinary tract infections
• Bladder tumor.
• Bladder stones

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit University

Asyut, Assuit, 2063045, Egypt

RECRUITING

Related 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: 10.1007/s00192-008-0742-4. Epub 2008 Oct 29.

  PMID: 18958382 RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• tharwat gm mohamed

  Assiut University

  PRINCIPAL INVESTIGATOR

• Mustafa mb bahlool, professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

tharwat gl mohammed

CONTACT

01151166826; tharwat.fares3@gmail.com

tharwat gl mohamed

CONTACT

01151166826; tharwat.fares3@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: May 30, 2021
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)