Genetic predisposition in women with pelvic organ prolapse

Not Applicable

Recruiting

• Conditions: Pelvic Organ Prolapse; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12623000279628
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-15
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 1200

Inclusion Criteria

All participants (surgical and genome-only study):
1.Aged between 18 and 55
2. Women (including all people with female reproductive anatomy [but no history of male hormone therapy])
3.Able to give informed consent for participation

Prolapse group for both studies:
1. A previously or currently diagnosed POP-Q grade 3 or 4 pelvic organ prolapse

Surgical prolapse group:
1.Undergoing planned pelvic prolapse repair surgery

Surgical control group:
1. Undergoing a planned abdominal hysterectomy.

No further specific, inclusion criteria for the genome-only study

Exclusion Criteria

All participants:
1. Diagnosed primary genetic disorder affecting connective tissue or a secondary disorder that affects connective tissue such as autoimmune diseases

Control group for both surgical and genome-only studies:
1. First degree relative with a previously or currently diagnosed (prior to age 55) POP-Q grade 3 or 4 pelvic organ prolapse
2. Para 0

Surgical group (both prolapse and controls)
1.Taking anti-coagulant medications
2.Any medical condition that, in the assessment of the operating surgeon, contraindicates taking a tissue biopsy

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of participants (cases vs controls) with gene-altering, rare variants in genes relevant to pelvic floor connective tissue (identified in the surgical study) as analysed by whole genome sequencing of whole-blood DNA[ 1 year post-recruitment]

Secondary Outcome Measures

Name	Time	Method
Quantity of collagen breakdown-products in the urine of surgical cases vs controls, as measured by commercially available ELISA kits[ 2-months post sample collection];Expression of extracellular proteins in the connective tissue of the anterior vaginal wall, as measured by non-targeted mass-spec. [ 6-months post sample collection];Quantity of elastic-fibre breakdown-products in the urine of surgical cases vs controls, as measured by commercially available ELISA kits[ 2 months post-sample collection]