Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery

Pelvic Organ Prolapse Clinical Trial

— PRP  

Official title:

Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05731284
• Other study ID #: IRB-300009943
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: Isuzu Meyer, MD. MSPH
• Phone: (205) 996-9580
• Email: imeyer[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2028
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Desire surgical treatment via a transvaginal native tissue approach.

• Completed child-bearing

Exclusion Criteria:

• Unable to follow-up, not willing to, or unable to participate in the proposed study

• Prior pelvic surgery within the past 12 months

• Prior anterior/apical suspension procedures

• Prior graft augmented prolapse surgery

• Pelvic/abdominal radiation

• Pelvic mass

• History of solid organ malignancy

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Platelet rich plasma (PRP) Injection
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.
• Placebo
Normal saline Injection

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior wall descensus measured by the POP-Q System, Ba point	Anterior wall descensus measured by the POP-Q System, Ba point	12 month
Secondary	Apical wall descensus measured by the POP-Q System, C point	Apical wall descensus measured by the POP-Q System, C point	12 months
Secondary	Posterior wall descensus	Posterior wall descensus measured by the POP-Q System, Bp point	12 months
Secondary	Leading edge	leading edge (Ba, C, or Bp) beyond the hymen (>0)	12 months
Secondary	Safety outcomes	operative time, blood loss, intra-, peri/postoperative adverse events	12 months
Secondary	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
Secondary	Retreatment	Retreatment for prolapse: pessary or surgery - dichotomous (failure: retreatment)	12 months