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Biological

Platelet-Rich Plasma Injection for Stress Incontinence

N/A

Waitlist Available

Research Sponsored by Annah J. Vollstedt

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women aged 18 years or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months

Awards & highlights

Study Summary

This trial will study whether platelet-rich plasma (PRP) is an effective treatment for female stress urinary incontinence (SUI), compared to placebo. Subjects will be injected with PRP or placebo, and outcomes will be measured at 6 months.

Who is the study for?

This trial is for women over 18 with stress urinary incontinence, where stress symptoms are more frequent than urge symptoms. They must not be pregnant, trying to conceive, or breastfeeding and should have no history of certain cancers or pelvic surgeries. Women on anti-inflammatory, anti-platelet, or anticoagulant medications cannot participate.Check my eligibility

What is being tested?

The study tests the effectiveness of platelet-rich plasma injections versus a saline placebo in treating female stress urinary incontinence. Participants will receive an injection into the vaginal wall and will be monitored for improvements in urinary control and quality of life.See study design

What are the potential side effects?

Potential side effects may include discomfort at the injection site, minor bleeding or bruising, infection risk at the injection area, and possible allergic reactions to components within PRP.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman aged 18 or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Negative urinary stress test (no leakage noted on examination during cough or Valsalva maneuvers at a standardized bladder volume of 300 mL

Subjective outcome with improvement in the Patient Global Impression of Improvement (PGI-I), with positive response defined as "very much better" (1) or "much better" (2)

Secondary outcome measures

Female Sexual Function Index (FSFI) scores

Incontinence-Quality of Life (I-QOL) scores

Perception of Monetary Value

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Platelet-rich PlasmaExperimental Treatment1 Intervention

These subjects will have the active PRP injected into their anterior vaginal wall.

Group II: Placebo (saline)Placebo Group1 Intervention

These subjects will have a saline placebo injected into the anterior vaginal wall.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Platelet-rich plasma injection

2019

N/A

~40

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Annah J. VollstedtLead Sponsor

Media Library

Platelet-rich plasma (Biological) Clinical Trial Eligibility Overview. Trial Name: NCT05390970 — N/A

Stress Incontinence Research Study Groups: Platelet-rich Plasma, Placebo (saline)

Stress Incontinence Clinical Trial 2023: Platelet-rich plasma Highlights & Side Effects. Trial Name: NCT05390970 — N/A

Platelet-rich plasma (Biological) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05390970 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What principal goals is this medical study attempting to accomplish?

"The objective of this six-month evaluation is to measure the Patient Global Impression of Improvement (PGI-I) along with Female Sexual Function Index (FSFI), Incontinence Quality Of Life (I-QOL), and Questionnaire for Urinary Incontinence Diagnosis (QUID). A response deemed successful would be a 'very much better' or 'much better' rating on the PGI-I."

Answered by AI

Is eligibility open for enrollment in this trial?

"This trial is open to 50 individuals, aged 18 and above, with urinary incontinence. Women are the primary demographic of interest here. In order for a participant to qualify they must have pure or primarily stress-induced urinary issues as per MESA questionnaire scores, be observed leaking during a provocation test at bladder volume less than 300mL, and have post void residuals under 150 mL."

Answered by AI

Is this investigation accepting participants above the age of 75?

"This research is open to participants who are aged eighteen and above, but not exceeding ninety-nine years."

Answered by AI

Are there vacancies available to join this clinical trial?

"Clinicaltrials.gov confirms that this medical experiment is not actively recruiting patients, with initial posting having taken place on May 23rd and the most recent update being made on November 2nd 2022. Fortunately, there are currently 151 other trials open to volunteers right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Platelet-Rich Plasma for Stress Urinary Incontinence

Annah J. Vollstedt 2022. "Platelet-Rich Plasma for Stress Urinary Incontinence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05390970.

All > Urinary Incontinence