Pelvic Organ ProlapsePRPNCT05731284
Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery
A study testing Platelet rich plasma (PRP) Injection in people with Pelvic Organ Prolapse, run by University of Alabama at Birmingham at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Platelet rich plasma (PRP) Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Desire surgical treatment via a transvaginal native tissue approach.
- Completed child-bearing
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
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
Read the 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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Platelet rich plasma (PRP) Injection, Placebo
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasma (PRP) InjectionProcedure or surgery
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.
PlaceboProcedure or surgery
Normal saline Injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Platelet rich plasma (PRP) Injection |
| 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. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior wall descensus measured by the POP-Q System, Ba point
Anterior wall descensus measured by the POP-Q System, Ba point
Measured: 12 month
Secondary outcomes (6)
Apical wall descensus measured by the POP-Q System, C point
Apical wall descensus measured by the POP-Q System, C point
Measured: 12 months
Posterior wall descensus
Posterior wall descensus measured by the POP-Q System, Bp point
Measured: 12 months
Leading edge
leading edge (Ba, C, or Bp) beyond the hymen (>0)
Measured: 12 months
Safety outcomes
operative time, blood loss, intra-, peri/postoperative adverse events
Measured: 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)
Measured: 12 months
Retreatment
Retreatment for prolapse: pessary or surgery - dichotomous (failure: retreatment)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Jul 2023
- Primary completion1 Jul 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isuzu Meyer, University of Alabama at Birmingham
- Investigators
- Isuzu Meyer, MD, MSPH, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731284
- Sponsor's protocol ID
- IRB-300009943
- Other IDs
- UAB
- Acronym
- PRP
- Status last verified
- Jul 2026
- First submitted
- 26 Jan 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery
- ClinicalTrials.gov ID
- NCT05731284
- Acronym / sponsor ID
- PRP / IRB-300009943
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjunct Platelet rich plasma (PRP) therapy | Active comparator | Procedure: Platelet rich plasma (PRP) InjectionStudy 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. |
| Normal saline | Placebo comparator | Procedure: PlaceboPlacebo: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Desire surgical treatment via a transvaginal native tissue approach.
- Completed child-bearing
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich plasma (PRP) InjectionRandomly 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. | Procedure or surgery | Adjunct Platelet rich plasma (PRP) therapy |
| PlaceboNormal saline Injection | Procedure or surgery | Normal saline |
Primary outcome
Anterior wall descensus measured by the POP-Q System, Ba point
Time frame: 12 month
Anterior wall descensus measured by the POP-Q System, Ba point
6 secondary outcomes
Apical wall descensus measured by the POP-Q System, C point
Time frame: 12 months
Posterior wall descensus
Time frame: 12 months
Leading edge
Time frame: 12 months
Safety outcomes
Time frame: 12 months
Subjective
Time frame: 12 months
Retreatment
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isuzu Meyer, MD, MSPH principal investigator
The University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich plasma (PRP) Injection in people with Pelvic Organ Prolapse, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior wall descensus measured by the POP-Q System, Ba point (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.