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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Grant/Funding Number | UAB Center for Women's Reproductive Health (CWRH) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjunct Platelet rich plasma (PRP) therapy | Active Comparator | 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. |
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| Normal saline | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet rich plasma (PRP) Injection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior wall descensus measured by the POP-Q System, Ba point | Anterior wall descensus measured by the POP-Q System, Ba point | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Apical wall descensus measured by the POP-Q System, C point | Apical wall descensus measured by the POP-Q System, C point | 12 months |
| Posterior wall descensus | Posterior wall descensus measured by the POP-Q System, Bp point |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isuzu Meyer, MD, MSPH | The University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Masking: Participants and study examiners performing the postoperative assessment will remain masked to the intervention assignment for the study duration, unless a medical indication for unmasking is identified.
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| Placebo | Procedure | Normal saline Injection |
|
| 12 months |
| Leading edge | leading edge (Ba, C, or Bp) beyond the hymen (>0) | 12 months |
| Safety outcomes | operative time, blood loss, intra-, peri/postoperative adverse events | 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) | 12 months |
| Retreatment | Retreatment for prolapse: pessary or surgery - dichotomous (failure: retreatment) | 12 months |