Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet-rich Plasma | Experimental | These subjects will have the active PRP injected into their anterior vaginal wall. |
|
| Placebo (saline) | Placebo Comparator | These subjects will have a saline placebo injected into the anterior vaginal wall. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet-rich plasma injection | Procedure | Injection of autologous platelet-rich plasma into the anterior vaginal wall |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 6-months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
Not provided
Recruitment occurred from May 2022 to April 2023 in a large academic medical institution.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Platelet-rich Plasma | These subjects will have the active PRP injected into their anterior vaginal wall. |
| FG001 | Placebo (Saline) | These subjects will have a saline placebo injected into the anterior vaginal wall. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Platelet-rich Plasma | These subjects will have the active PRP injected into their anterior vaginal wall. Platelet-rich plasma injection: Injection of autologous platelet-rich plasma into the anterior vaginal wall |
| BG001 | Placebo (Saline) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 6-months |
|
Adverse events were collected for 6 months after the procedure was performed.
All participants were at risk for serious adverse events
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Platelet-rich Plasma | These subjects will have the active PRP injected into their anterior vaginal wall. Platelet-rich plasma injection: Injection of autologous platelet-rich plasma into the anterior vaginal wall |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal spotting | Surgical and medical procedures | Clavien-Dindo | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Annah J. Vollstedt | University of Iowa Healthcare | 712-253-1627 | annah-vollstedt@uiowa.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2022 | May 14, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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". | 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". | 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 | 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" | 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 | after injection |
These subjects will have a saline placebo injected into the anterior vaginal wall. Platelet-rich plasma injection: Injection of autologous platelet-rich plasma into the anterior vaginal wall |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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) | Posted | Count of Participants | Participants | 6-months |
|
|
|
| Secondary | 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". | Posted | Median | Inter-Quartile Range | score on a scale | 6-months |
|
|
|
| Secondary | 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". | Posted | Median | Inter-Quartile Range | score on a scale | 6-months |
|
|
|
| Secondary | 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". | Posted | Median | Inter-Quartile Range | score on a scale | 6-months |
|
|
|
| Secondary | Perception of Monetary Value | How much money the subject would be willing to pay for the procedure; this was a free text question | Posted | Median | Inter-Quartile Range | US dollars | 6-months |
|
|
|
| Secondary | 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" | Posted | Median | Standard Deviation | units on a scale | after injection |
|
|
|
| Secondary | 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 | Posted | Number | units on a scale | after injection |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 23 |
| 25 |
| EG001 | Placebo (Saline) | These subjects will have a saline placebo injected into the anterior vaginal wall. Platelet-rich plasma injection: Injection of autologous platelet-rich plasma into the anterior vaginal wall | 0 | 25 | 0 | 25 | 23 | 25 |
| Heavy Vaginal bleeding | Reproductive system and breast disorders | Clavien-Dindo | Systematic Assessment |
|
| Burning with urination | Renal and urinary disorders | Clavien-Dindo | Systematic Assessment |
|
| Blood in urine | Renal and urinary disorders | Clavien-Dindo | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Clavien-Dindo | Systematic Assessment |
|
| Vaginal discomfort | General disorders | Clavien-Dindo | Systematic Assessment |
|
| vaginal pain | General disorders | Clavien-Dindo | Systematic Assessment |
|
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |