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

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05731284
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 58
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: Platelet rich plasma (PRP) Injection; Procedure: Placebo	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Adjunct Platelet rich plasma (PRP) therapy 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; 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 Comparator: Normal saline 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; Normal saline Injection

Outcome Measures

Primary Outcome Measures

1. Anterior wall descensus measured by the POP-Q System, Ba point [12 month]

   Anterior wall descensus measured by the POP-Q System, Ba point

Secondary Outcome Measures

1. Apical wall descensus measured by the POP-Q System, C point [12 months]

   Apical wall descensus measured by the POP-Q System, C point

2. Posterior wall descensus [12 months]

   Posterior wall descensus measured by the POP-Q System, Bp point

3. Leading edge [12 months]

   leading edge (Ba, C, or Bp) beyond the hymen (>0)

4. Safety outcomes [12 months]

   operative time, blood loss, intra-, peri/postoperative adverse events

5. Subjective [12 months]

   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)

6. Retreatment [12 months]

   Retreatment for prolapse: pessary or surgery - dichotomous (failure: retreatment)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35249

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Isuzu Meyer, MD, MSPH, The University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Isuzu Meyer, Associate Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT05731284
• Other Study ID Numbers: IRB-300009943
• First Posted: Feb 16, 2023
• Last Update Posted: Feb 16, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Feb 16, 2023