An interventional study of Platelet rich plasma (PRP) Injection and Placebo in Pelvic Organ Prolapse, sponsored by University of Alabama at Birmingham. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
The purpose of the study is to evaluate the surgical outcomes of injecting platelet-rich plasma (PRP) into the vaginal tissue as an adjunct therapy at the time of prolapse surgery
Platelet rich plasma (PRP) is an autologous product with high levels of platelets which are concentrated with bioactive growth factors responsible for accelerating tissue healing by stimulating the number of reparative cells to create collagen production, angiogenesis and neurogenesis. The overarching goal is to evaluate the effectiveness and safety of the adjunct application of PRP in the fibromuscular connective tissue (the site of anterior tissue plication) at the time of anterior colporrhaphy (the site of highest recurrence risk) in women undergoing native tissue vaginal prolapse repair, to promote tissue healing and regeneration, thus to improve surgical outcomes.
509 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 329 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Study Interventions: PRP will be injected in a systematic grid like fashion into the fibromuscular connective tissue of the anterior compartment following vaginal incision and dissection.
Procedure: Platelet rich plasma (PRP) Injection
Placebo: Normal saline will be injected in a systematic grid like fashion into the fibromuscular connective tissue of the anterior compartment following vaginal incision and dissection.
Procedure: Placebo
Randomly picked (like the flip of a coin) by a computer to receive either platelet-rich plasma (PRP) or normal saline. This is a double-blind study. During vaginal prolapse surgery, the surgeon will inject PRP into the vaginal tissue at the surgical site.
Normal saline Injection
Anterior wall descensus measured by the POP-Q System, Ba point
Anterior wall descensus measured by the POP-Q System, Ba point
Time frame: 12 month
Apical wall descensus measured by the POP-Q System, C point
Apical wall descensus measured by the POP-Q System, C point
Time frame: 12 months
Posterior wall descensus
Posterior wall descensus measured by the POP-Q System, Bp point
Time frame: 12 months
Leading edge
leading edge (Ba, C, or Bp) beyond the hymen (\>0)
Time frame: 12 months
Safety outcomes
operative time, blood loss, intra-, peri/postoperative adverse events
Time frame: 12 months
Subjective
Bothersome vaginal bulge symptoms (positive response to "usually have a bulge or something falling out that you can see or feel in your vaginal area" from the PFDI-20)
Time frame: 12 months
Retreatment
Retreatment for prolapse: pessary or surgery - dichotomous (failure: retreatment)
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham