search
Back to results

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

Primary Purpose

Pelvic Organ Prolapse

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Platelet rich plasma (PRP) Injection
Placebo
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Adjunct Platelet rich plasma (PRP) therapy

Normal saline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Apical wall descensus measured by the POP-Q System, C point
Apical wall descensus measured by the POP-Q System, C point
Posterior wall descensus
Posterior wall descensus measured by the POP-Q System, Bp point
Leading edge
leading edge (Ba, C, or Bp) beyond the hymen (>0)
Safety outcomes
operative time, blood loss, intra-, peri/postoperative adverse events
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)
Retreatment
Retreatment for prolapse: pessary or surgery - dichotomous (failure: retreatment)

Full Information

First Posted
January 26, 2023
Last Updated
July 6, 2023
Sponsor
University of Alabama at Birmingham
search

1. Study Identification

Unique Protocol Identification Number
NCT05731284
Brief Title
Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery
Acronym
PRP
Official Title
Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
July 30, 2026 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjunct Platelet rich plasma (PRP) therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Platelet rich plasma (PRP) Injection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
Normal saline Injection
Primary Outcome Measure Information:
Title
Anterior wall descensus measured by the POP-Q System, Ba point
Description
Anterior wall descensus measured by the POP-Q System, Ba point
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Apical wall descensus measured by the POP-Q System, C point
Description
Apical wall descensus measured by the POP-Q System, C point
Time Frame
12 months
Title
Posterior wall descensus
Description
Posterior wall descensus measured by the POP-Q System, Bp point
Time Frame
12 months
Title
Leading edge
Description
leading edge (Ba, C, or Bp) beyond the hymen (>0)
Time Frame
12 months
Title
Safety outcomes
Description
operative time, blood loss, intra-, peri/postoperative adverse events
Time Frame
12 months
Title
Subjective
Description
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
Title
Retreatment
Description
Retreatment for prolapse: pessary or surgery - dichotomous (failure: retreatment)
Time Frame
12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isuzu Meyer, MD. MSPH
Phone
(205) 996-9580
Email
imeyer@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sunita Patel
Phone
2059960241
Email
sunitapatel@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isuzu Meyer, MD, MSPH
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isuzu Meyer, MD, MSPH
Phone
205-996-9580
Email
imeyer@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Sunita Patel
Phone
205-996-0241
Email
sunitapatel@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs