Urinary Incontinence,StressPhase 3NCT05390970
Platelet-Rich Plasma for Stress Urinary Incontinence
A Phase 3 study testing Platelet-rich plasma injection in people with Urinary Incontinence,Stress and Urinary Incontinence, run by Annah J. Vollstedt at 1 site in United States.
Trial summary
The aim of this randomized controlled trial study is to evaluate the efficacy and safety of platelet-rich plasma (PRP) in the treatment of female stress urinary incontinence (SUI), compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence,Stress, Urinary Incontinence
- What is being tested?
- Platelet-rich plasma 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
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2022to 13 Dec 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 18 years or older
- Pure or stress-predominant urinary incontinence with the Medical, Epidemiologic, and Social Aspects of Aging questionnaire (MESA) stress incontinence symptom score greater than MESA urge incontinence symptom score
- Observation of leakage by provocative stress test at bladder volume £ 300 mL [15]
- Post void residual < 150 mL
Who cannot join
- Currently pregnant or trying to conceive
- Currently breastfeeding
- Interstitial cystitis
- Urgency urinary incontinence predominance or currently being treated for overactive bladder with medication, percutaneous tibial nerve stimulation, bladder chemodenervation, or sacral neuromodulation
- Currently being treated for a sexually transmitted disease
- Pelvic organ prolapse greater than stage 2 according to the Pelvic Organ Prolapse Quantification System
Show all 15Show fewer
- Periurethral mass
- Active gynecologic, urologic or colorectal cancer
- History of pelvic radiation
- Psychological disorder making the patient unable to provide consent
- Undiagnosed abnormal uterine bleeding
- Genitourinary fistula
- Prior SUI surgery
- Use of anti-platelet or anti-coagulant medication
- Regular use of non-steroidal anti-inflammatorie
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Platelet-Rich Plasma Injection for the Treatment of Female Stress Urinary Incontinence: A Randomized Placebo-Controlled Study
The aim of this randomized controlled trial study is to evaluate the efficacy and safety of platelet-rich plasma (PRP) in the treatment of female stress urinary incontinence (SUI), compared to placebo. Subjects will undergo an injection of PRP (or injectable saline placebo) into the anterior vaginal wall in the office. Primary outcomes will include a negative urinary stress test plus improvement with the Patient Global Impression of Improvement (PGI-I) at 6-months. Secondary outcomes will include the Female Sexual Function Index (FSFI), the Incontinence Quality of life (I-QOL), Questionnaire for Urinary Incontinence Diagnosis (QUID), and the visual analog scale for pain.
Read the detailed description
Platelet-rich plasma (PRP) is an autologous solution of human plasma with a high concentration of platelets. While the preparation and injection of PRP is not a new technology, it has not been well-studied in the field of urogynecology. Small case series have suggested PRP may be used in the treatment of stress urinary incontinence (SUI). The aim of this randomized controlled trial study is to evaluate the efficacy and safety of PRP in the treatment of female SUI, compared to placebo. Adult females with SUI or with stress-predominant mixed urinary incontinence will be eligible. Subjects will undergo an injection of PRP (or injectable saline) into the anterior vaginal wall in the office. At baseline and at time points of 1, 3, and 6 months, subjects will complete the validated questionnaires. A pelvic exam with a stress test will be performed by a blinded provider at the 3 and 6-month visits. Primary outcomes will include a negative urinary stress test plus improvement with the Patient Global Impression of Improvement (PGI-I) at 6-months. Secondary outcomes will include the Female Sexual Function Index (FSFI), the Incontinence Quality of life (I-QOL), Questionnaire for Urinary Incontinence Diagnosis (QUID), and the visual analog scale for pain.
- Conditions
- Urinary Incontinence,Stress, Urinary Incontinence
- Being tested
- Platelet-rich plasma injection
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich plasma injectionProcedure or surgery
Injection of autologous platelet-rich plasma into the anterior vaginal wall
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich Plasma | Experimental | These subjects will have the active PRP injected into their anterior vaginal wall. Receives: Procedure: Platelet-rich plasma injection |
| Placebo (saline) | Placebo comparator | These subjects will have a saline placebo injected into the anterior vaginal wall. Receives: Procedure: Platelet-rich plasma injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Negative Urinary Stress Test (no Leakage Noted on Examination During Cough or Valsalva Maneuvers at a Standardized Bladder Volume of 300 mL)
Negative urinary stress test (no leakage noted on examination during cough or Valsalva maneuvers at a standardized bladder volume of 300 mL
Measured: 6-months
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)
Answered "very much better" or "much better" on the Patient Global Impression of Improvement (PGI-I)
Measured: 6-months
Secondary outcomes (6)
Female Sexual Function Index (FSFI) Scores
6-months FSFI score in the PRP group versus the saline group. Score range is 0-36, the higher the value the greater the level of sexual functioning. Scale ranges from 0 "No sexual activity", 1 "Almost never or never" to 5 "Almost always or always" OR 0 "No sexual activity", 1 "Extremely difficult or impossible" to 5 "Not difficult".
Measured: 6-months
Incontinence-Quality of Life (I-QOL) Scores
How the subject's quality of life is different related to urinary leakage after the procedure based on their I-QOL score. Score ranges from 22-110, the higher the score the better their quality of life. Scale goes from 1 "Extremely' to 5 "Not at all".
Measured: 6-months
Questionnaire for Urinary Incontinence Diagnosis (QUID)
How severe the urinary leakage is after the procedure based on the QUID score. Score ranges from 0-30. Scale ranges from 0 "None of the time" to 5 "All of the time".
Measured: 6-months
Perception of Monetary Value
How much money the subject would be willing to pay for the procedure; this was a free text question
Measured: 6-months
Visual Analog Scale (VAS) for Patient Pain/Discomfort
How painful the procedure itself is from 0 to 10 with 0 being no pain and 10 being "pain as bad as it could be"
Measured: after injection
Visual Analog Scale (VAS) for Procedure Difficulty (by Provider)
how difficult the procedure is for the patient on a scale from 0 to 10 with 0 being not difficult at all and 10 being the most difficult procedure to perform
Measured: after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start23 May 2022
- Primary completion13 Dec 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Incontinence,StressStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Annah J. Vollstedt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Annah J. Vollstedt, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390970
- Sponsor's protocol ID
- 202112270
- Status last verified
- Aug 2024
- First submitted
- 12 May 2022
- Last updated
- 29 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-Rich Plasma Injection for the Treatment of Female Stress Urinary Incontinence: A Randomized Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT05390970
- Acronym / sponsor ID
- 202112270
- Conditions
- Urinary Incontinence,Stress, Urinary Incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Annah J. VollstedtUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Posted 29 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized controlled trial study is to evaluate the efficacy and safety of platelet-rich plasma (PRP) in the treatment of female stress urinary incontinence (SUI), compared to placebo. Subjects will undergo an injection of PRP (or injectable saline placebo) into the anterior vaginal wall in the office. Primary outcomes will include a negative urinary stress test plus improvement with the Patient Global Impression of Improvement (PGI-I) at 6-months. Secondary outcomes will include the Female Sexual Function Index (FSFI), the Incontinence Quality of life (I-QOL), Questionnaire for Urinary Incontinence Diagnosis (QUID), and the visual analog scale for pain.
Detailed description
Platelet-rich plasma (PRP) is an autologous solution of human plasma with a high concentration of platelets. While the preparation and injection of PRP is not a new technology, it has not been well-studied in the field of urogynecology. Small case series have suggested PRP may be used in the treatment of stress urinary incontinence (SUI). The aim of this randomized controlled trial study is to evaluate the efficacy and safety of PRP in the treatment of female SUI, compared to placebo. Adult females with SUI or with stress-predominant mixed urinary incontinence will be eligible. Subjects will undergo an injection of PRP (or injectable saline) into the anterior vaginal wall in the office. At baseline and at time points of 1, 3, and 6 months, subjects will complete the validated questionnaires. A pelvic exam with a stress test will be performed by a blinded provider at the 3 and 6-month visits. Primary outcomes will include a negative urinary stress test plus improvement with the Patient Global Impression of Improvement (PGI-I) at 6-months. Secondary outcomes will include the Female Sexual Function Index (FSFI), the Incontinence Quality of life (I-QOL), Questionnaire for Urinary Incontinence Diagnosis (QUID), and the visual analog scale for pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich Plasma | Experimental | Procedure: Platelet-rich plasma injectionThese subjects will have the active PRP injected into their anterior vaginal wall. |
| Placebo (saline) | Placebo comparator | Procedure: Platelet-rich plasma injectionThese subjects will have a saline placebo injected into the anterior vaginal wall. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged 18 years or older
- Pure or stress-predominant urinary incontinence with the Medical, Epidemiologic, and Social Aspects of Aging questionnaire (MESA) stress incontinence symptom score greater than MESA urge incontinence symptom score
- Observation of leakage by provocative stress test at bladder volume £ 300 mL [15]
- Post void residual < 150 mL
Key exclusion criteria (15 listed)
- Currently pregnant or trying to conceive
- Currently breastfeeding
- Interstitial cystitis
- Urgency urinary incontinence predominance or currently being treated for overactive bladder with medication, percutaneous tibial nerve stimulation, bladder chemodenervation, or sacral neuromodulation
- Currently being treated for a sexually transmitted disease
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 injectionInjection of autologous platelet-rich plasma into the anterior vaginal wall | Procedure or surgery | Placebo (saline), Platelet-rich Plasma |
Primary outcome
Number of Participants With Negative Urinary Stress Test (no Leakage Noted on Examination During Cough or Valsalva Maneuvers at a Standardized Bladder Volume of 300 mL)
Time frame: 6-months
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)
Time frame: 6-months
Answered "very much better" or "much better" on the Patient Global Impression of Improvement (PGI-I)
6 secondary outcomes
Female Sexual Function Index (FSFI) Scores
Time frame: 6-months
Incontinence-Quality of Life (I-QOL) Scores
Time frame: 6-months
Questionnaire for Urinary Incontinence Diagnosis (QUID)
Time frame: 6-months
Perception of Monetary Value
Time frame: 6-months
Visual Analog Scale (VAS) for Patient Pain/Discomfort
Time frame: after injection
Visual Analog Scale (VAS) for Procedure Difficulty (by Provider)
Time frame: after injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platelet-rich plasma injection in people with Urinary Incontinence,Stress and Urinary Incontinence, run by Annah J. Vollstedt 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 4 inclusion and 15 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: finished, as of the sponsor's last update on 29 Aug 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Negative Urinary Stress Test (no Leakage Noted on Examination During Cough or Valsalva Maneuvers at a Standardized Bladder Volume of 300 mL) (time frame: 6-months). The study lists 2 primary outcomes in all. 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 29 Aug 2024.