Urinary Incontinence,Stress, Urinary Incontinence
Conditions
Brief 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. 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.
Interventions
PROCEDUREPlatelet-rich plasma injection
Injection of autologous platelet-rich plasma into the anterior vaginal wall
Sponsors
Annah J. Vollstedt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
1. Women aged 18 years or older 2. 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 3. Observation of leakage by provocative stress test at bladder volume £ 300 mL \[15\] 4. Post void residual \< 150 mL
Exclusion criteria
1. Currently pregnant or trying to conceive 2. Currently breastfeeding 3. Interstitial cystitis 4. Urgency urinary incontinence predominance or currently being treated for overactive bladder with medication, percutaneous tibial nerve stimulation, bladder chemodenervation, or sacral neuromodulation 5. Currently being treated for a sexually transmitted disease 6. Pelvic organ prolapse greater than stage 2 according to the Pelvic Organ Prolapse Quantification System 7. Periurethral mass 8. Active gynecologic, urologic or colorectal cancer 9. History of pelvic radiation 10. Psychological disorder making the patient unable to provide consent 11. Undiagnosed abnormal uterine bleeding 12. Genitourinary fistula 13. Prior SUI surgery 14. Use of anti-platelet or anti-coagulant medication 15. Regular use of non-steroidal anti-inflammatorie
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) | 6-months | Answered very much better or much better on the Patient Global Impression of Improvement (PGI-I) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire for Urinary Incontinence Diagnosis (QUID) | 6-months | 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. |
| Perception of Monetary Value | 6-months | How much money the subject would be willing to pay for the procedure; this was a free text question |
| Female Sexual Function Index (FSFI) Scores | 6-months | 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. |
| Visual Analog Scale (VAS) for Procedure Difficulty (by Provider) | after injection | 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 |
| Visual Analog Scale (VAS) for Patient Pain/Discomfort | after injection | 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 |
| Incontinence-Quality of Life (I-QOL) Scores | 6-months | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred from May 2022 to April 2023 in a large academic medical institution.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| 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 | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Placebo (Saline) | Total | Platelet-rich Plasma |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 50 Participants | 25 Participants |
| Age, Continuous | 45 years | 47 years | 48 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 47 Participants | 23 Participants |
| Region of Enrollment United States | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 23 / 25 | 23 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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
Time frame: 6-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Platelet-rich Plasma | 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) | 15 Participants |
| Placebo (Saline) | 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) | 16 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)
Time frame: 6-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Platelet-rich Plasma | 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) | 4 Participants |
| Placebo (Saline) | 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) | 1 Participants |
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.
Time frame: 6-months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Platelet-rich Plasma | Female Sexual Function Index (FSFI) Scores | 27 score on a scale |
| Placebo (Saline) | Female Sexual Function Index (FSFI) Scores | 25 score on a scale |
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.
Time frame: 6-months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Platelet-rich Plasma | Incontinence-Quality of Life (I-QOL) Scores | 87 score on a scale |
| Placebo (Saline) | Incontinence-Quality of Life (I-QOL) Scores | 88 score on a scale |
Secondary
Perception of Monetary Value
How much money the subject would be willing to pay for the procedure; this was a free text question
Time frame: 6-months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Platelet-rich Plasma | Perception of Monetary Value | 100 US dollars |
| Placebo (Saline) | Perception of Monetary Value | 50 US dollars |
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.
Time frame: 6-months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Platelet-rich Plasma | Questionnaire for Urinary Incontinence Diagnosis (QUID) | 10.0 score on a scale |
| Placebo (Saline) | Questionnaire for Urinary Incontinence Diagnosis (QUID) | 10.0 score on a scale |
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
Time frame: after injection
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Platelet-rich Plasma | Visual Analog Scale (VAS) for Patient Pain/Discomfort | 2.25 units on a scale | Standard Deviation 1.45 |
| Placebo (Saline) | Visual Analog Scale (VAS) for Patient Pain/Discomfort | 2.87 units on a scale | Standard Deviation 2.07 |
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
Time frame: after injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Platelet-rich Plasma | Visual Analog Scale (VAS) for Procedure Difficulty (by Provider) | 2 units on a scale |
| Placebo (Saline) | Visual Analog Scale (VAS) for Procedure Difficulty (by Provider) | 2.54 units on a scale |