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Effect Of Intrapubocervical Fascia Platelet-Rich Plasma Injection to PDGF, VEGF and FGF Levels, IL-6 Levels, miRNA Levels, PFDI Score, POP-Q Grading and Quality Life Score in Patients With Cystocele: A Randomized Control Trial

Effect Of Intrapubocervical Fascia Platelet-Rich Plasma Injection to PDGF, VEGF and FGF Levels, IL-6 Levels, miRNA Levels, PFDI Score, POP-Q Grading and Quality Life Score in Patients With Cystocele: A Randomized Control Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250218006
Enrollment
66
Registered
2025-02-18
Start date
2024-03-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystocele Cystocele

Interventions

Participants undergo cystocele repair (anterior colporrhaphy) without any additional PRP injection. The pubocervical fascia is sutured using PGA sutures after the standard surgical procedure.,Particip
Experimental Procedure/Surgery,Experimental Procedure/Surgery
Control Group : anterior colporrhaphy alone,Intervention Group

Sponsors

Faculty of Medicine, Universitas Riau
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Menopausal women diagnosed with grade 3 or 4 cystocele (POP-Q) who provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with platelet disorders or severe thrombocytopenia 2. NSAID use within 48 hours prior to intervention 3. Corticosteroid use in the past month 4. Prior POP surgery 5. Inability/unwillingness to comply with study procedures.

Design outcomes

Primary

MeasureTime frame
Improvement in Pelvic Organ Prolapse Quantification (POP-Q) Stage Day 90 postoperatively POP-Q assessment performed by a trained clinician. Improvement is defined as a reduction in POP-Q stage compared to baseline.

Secondary

MeasureTime frame
Reduction in Urinary Distress Inventory (UDI-6) Score Day 28 and Day 90 postoperatively Change in UDI-6 score measured using a validated questionnaire. Lower scores indicate improvement in urinary symptoms.,Reduction in Pelvic Floor Distress Inventory (PFDI-20) Score Day 28 and Day 90 postoperatively Change in PFDI-20 score measured using a validated questionnaire. Lower scores indicate improvement in pelvic floor symptoms.,Improvement in Quality of Life (QoL) Score Day 28 and Day 90 postoperatively Change in QoL score assessed using a validated quality of life instrument specific to pelvic floor disorders. Higher scores indicate better quality of life.,Platelet-Derived Growth Factor (PDGF) Levels Preoperative (Day 0) and Day 3 postoperatively Serum levels of PDGF measured via laboratory analysis to assess PRP-related growth factor activity.

Countries

Indonesia

Contacts

Public ContactEdy Fakhrizal

Fakultas Kedokteran Universitas Riau

dr.edyfakhrizal@lecturer.unri.ac.id081322215319

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026