Trial Outcomes & Findings for Platelet-Rich Plasma for Stress Urinary Incontinence (NCT NCT05390970)

NCT ID: NCT05390970

Last Updated: 2024-08-29

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 50 participants
• Primary outcome timeframe: 6-months
• Results posted on: 2024-08-29

Participant Flow

Recruitment occurred from May 2022 to April 2023 in a large academic medical institution.

Participant milestones

Measure	Platelet-rich Plasma These subjects will have the active PRP injected into their anterior vaginal wall.	Placebo (Saline) These subjects will have a saline placebo injected into the anterior vaginal wall.
Overall Study STARTED	25	25
Overall Study COMPLETED	24	23
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Platelet-Rich Plasma for Stress Urinary Incontinence

Baseline characteristics by cohort

Measure	Platelet-rich Plasma n=25 Participants 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	Placebo (Saline) n=25 Participants 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	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	48 years n=5 Participants	45 years n=7 Participants	47 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 6-months

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

Outcome measures

Measure	Platelet-rich Plasma n=24 Participants 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	Placebo (Saline) n=25 Participants 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
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	16 Participants

PRIMARY outcome

Timeframe: 6-months

Answered "very much better" or "much better" on the Patient Global Impression of Improvement (PGI-I)

Outcome measures

Measure	Platelet-rich Plasma n=25 Participants 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	Placebo (Saline) n=24 Participants 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
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	1 Participants

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Platelet-rich Plasma n=25 Participants 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	Placebo (Saline) n=25 Participants 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
Female Sexual Function Index (FSFI) Scores	27 score on a scale Interval 22.0 to 31.0	25 score on a scale Interval 17.0 to 31.0

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Platelet-rich Plasma n=25 Participants 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	Placebo (Saline) n=23 Participants 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
Incontinence-Quality of Life (I-QOL) Scores	87 score on a scale Interval 75.0 to 102.0	88 score on a scale Interval 62.0 to 94.0

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Platelet-rich Plasma n=25 Participants 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	Placebo (Saline) n=23 Participants 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
Questionnaire for Urinary Incontinence Diagnosis (QUID)	10.0 score on a scale Interval 7.0 to 13.0	10.0 score on a scale Interval 6.0 to 14.5

SECONDARY outcome

Timeframe: 6-months

How much money the subject would be willing to pay for the procedure; this was a free text question

Outcome measures

Measure	Platelet-rich Plasma n=25 Participants 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	Placebo (Saline) n=25 Participants 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
Perception of Monetary Value	100 US dollars Interval 50.0 to 200.0	50 US dollars Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 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"

Outcome measures

Measure	Platelet-rich Plasma n=25 Participants 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	Placebo (Saline) n=25 Participants 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
Visual Analog Scale (VAS) for Patient Pain/Discomfort	2.25 units on a scale Standard Deviation 1.45	2.87 units on a scale Standard Deviation 2.07

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Platelet-rich Plasma n=25 Participants 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	Placebo (Saline) n=25 Participants 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
Visual Analog Scale (VAS) for Procedure Difficulty (by Provider)	2 units on a scale	2.54 units on a scale

Adverse Events

Platelet-rich Plasma

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo (Saline)

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Platelet-rich Plasma n=25 participants at risk 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	Placebo (Saline) n=25 participants at risk 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
Surgical and medical procedures Vaginal spotting	24.0% 6/25 • Number of events 6 • Adverse events were collected for 6 months after the procedure was performed. All participants were at risk for serious adverse events	24.0% 6/25 • Number of events 6 • Adverse events were collected for 6 months after the procedure was performed. All participants were at risk for serious adverse events
Reproductive system and breast disorders Heavy Vaginal bleeding	4.0% 1/25 • Number of events 1 • Adverse events were collected for 6 months after the procedure was performed. All participants were at risk for serious adverse events	8.0% 2/25 • Number of events 2 • Adverse events were collected for 6 months after the procedure was performed. All participants were at risk for serious adverse events
Renal and urinary disorders Burning with urination	4.0% 1/25 • Number of events 1 • Adverse events were collected for 6 months after the procedure was performed. All participants were at risk for serious adverse events	4.0% 1/25 • Number of events 1 • Adverse events were collected for 6 months after the procedure was performed. All participants were at risk for serious adverse events
Renal and urinary disorders Blood in urine	16.0% 4/25 • Number of events 4 • Adverse events were collected for 6 months after the procedure was performed. All participants were at risk for serious adverse events	0.00% 0/25 • Adverse events were collected for 6 months after the procedure was performed. All participants were at risk for serious adverse events
Renal and urinary disorders Urinary Tract Infection	4.0% 1/25 • Number of events 1 • Adverse events were collected for 6 months after the procedure was performed. All participants were at risk for serious adverse events	16.0% 4/25 • Number of events 4 • Adverse events were collected for 6 months after the procedure was performed. All participants were at risk for serious adverse events
General disorders Vaginal discomfort	28.0% 7/25 • Number of events 7 • Adverse events were collected for 6 months after the procedure was performed. All participants were at risk for serious adverse events	36.0% 9/25 • Number of events 9 • Adverse events were collected for 6 months after the procedure was performed. All participants were at risk for serious adverse events
General disorders vaginal pain	12.0% 3/25 • Number of events 3 • Adverse events were collected for 6 months after the procedure was performed. All participants were at risk for serious adverse events	24.0% 6/25 • Number of events 6 • Adverse events were collected for 6 months after the procedure was performed. All participants were at risk for serious adverse events

Additional Information

Dr. Annah J. Vollstedt

University of Iowa Healthcare

Phone: 712-253-1627

Email: annah-vollstedt@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place