Trial Outcomes & Findings for ProVee Urethral Expander System IDE Study (ProVIDE) (NCT NCT05186740)
NCT ID: NCT05186740
Last Updated: 2025-12-01
Results Overview
This includes the rate of device or procedure related serious adverse events
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
221 participants
Primary outcome timeframe
Procedure - 12 months
Results posted on
2025-12-01
Participant Flow
All primary endpoint results are now entered. This Clinical Study Protocol and Statistical Analysis Plan has been redacted in accordance with the regulations at 42 CFR 11.48(a)(5). All SAEs reported have been adjudicated by CEC as not device or procedural related.
Participant milestones
| Measure |
Device: The ProVee Urethral Expander System
The ProVee Urethral Expander System consists of two components: a nitinol Expander implant and a 19Fr Delivery System designed to allow the Expander to be deployed under direct vision for the treatment arm.
ProVee Urethral Expander System: ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
|
Sham: Ureteroscope and Urethral Access Sheath
An ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure.
Urethral Access Sheath: The Urethral Access Sheath is introduced into the prostatic urethra to simulate the placement of the ProVee Expander.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
71
|
|
Overall Study
Sham Participants Crossed Over to Device at 3 Month Follow-up
|
0
|
64
|
|
Overall Study
COMPLETED
|
150
|
71
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ProVee Urethral Expander System IDE Study (ProVIDE)
Baseline characteristics by cohort
| Measure |
Device: The ProVee Urethral Expander System
n=150 Participants
The ProVee Urethral Expander System consists of two components: a nitinol Expander implant and a 19Fr Delivery System designed to allow the Expander to be deployed under direct vision for the treatment arm.
ProVee Urethral Expander System: ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
|
Sham: Ureteroscope and Urethral Access Sheath
n=71 Participants
An ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure.
Urethral Access Sheath: The Urethral Access Sheath is introduced into the prostatic urethra to simulate the placement of the ProVee Expander.
|
Total
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
64.0 Years
STANDARD_DEVIATION 8.7 • n=121 Participants
|
64.5 Years
STANDARD_DEVIATION 8.2 • n=122 Participants
|
64.2 Years
STANDARD_DEVIATION 8.4 • n=243 Participants
|
|
Sex/Gender, Customized
Male
|
150 Participants
n=121 Participants
|
71 Participants
n=122 Participants
|
221 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=121 Participants
|
6 Participants
n=122 Participants
|
25 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
128 Participants
n=121 Participants
|
63 Participants
n=122 Participants
|
191 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
5 Participants
n=243 Participants
|
PRIMARY outcome
Timeframe: Procedure - 12 monthsPopulation: At 3 month follow-up visit, 64 subjects were crossed over from Sham (Uretheroscope and urethral access sheath) to Device (The ProVee Urethral Expander System)
This includes the rate of device or procedure related serious adverse events
Outcome measures
| Measure |
Device: The ProVee Urethral Expander System
n=150 Participants
The ProVee Urethral Expander System consists of two components: a nitinol Expander implant and a 19Fr Delivery System designed to allow the Expander to be deployed under direct vision for the treatment arm.
ProVee Urethral Expander System: ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
|
Sham: Ureteroscope and Urethral Access Sheath
n=71 Participants
An ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure.
Urethral Access Sheath: The Urethral Access Sheath is introduced into the prostatic urethra to simulate the placement of the ProVee Expander.
|
Crossover ProVee Urethral Expander System
n=64 Participants
All subjects shall be unblinded following the 3 month follow-up visit. Those subjects randomized to the Sham Arm will be given the opportunity to "crossover" to the ProVee Urethral Expander System.
ProVee Urethral Expander System: ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
|
|---|---|---|---|
|
Safety: Number of Device or Procedure Related Serious Adverse Events (Time Frame: Procedure to 12 Months)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 7 days post treatment through to 12 monthsPopulation: At 3-month follow up, 64 subject were crossed over from Sham (Ureteroscope and Urethral Access Sheath) to Device (The ProVee Urethral Expander System).
The rate of extended post-operative urinary catheterization for inability to void among patients treated with the ProVee device.
Outcome measures
| Measure |
Device: The ProVee Urethral Expander System
n=150 Participants
The ProVee Urethral Expander System consists of two components: a nitinol Expander implant and a 19Fr Delivery System designed to allow the Expander to be deployed under direct vision for the treatment arm.
ProVee Urethral Expander System: ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
|
Sham: Ureteroscope and Urethral Access Sheath
n=71 Participants
An ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure.
Urethral Access Sheath: The Urethral Access Sheath is introduced into the prostatic urethra to simulate the placement of the ProVee Expander.
|
Crossover ProVee Urethral Expander System
n=64 Participants
All subjects shall be unblinded following the 3 month follow-up visit. Those subjects randomized to the Sham Arm will be given the opportunity to "crossover" to the ProVee Urethral Expander System.
ProVee Urethral Expander System: ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
|
|---|---|---|---|
|
Safety: Number of Participants With Need for Urinary Catheterization (Time Frame: >7 Days Post Procedure)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Procedure to 3 monthsPopulation: Following the 3 month follow up, 64 subjects were crossed over from sham (ureteroscope and urethral access sheath) to device (the ProVee ureteral expander system)
The ProVee Treatment Group will be considered superior to the Sham Treatment Group when the mean 3-month improvement from baseline score for the IPSS symptom questionnaire demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for the Sham Treatment Group alone.
Outcome measures
| Measure |
Device: The ProVee Urethral Expander System
n=150 Participants
The ProVee Urethral Expander System consists of two components: a nitinol Expander implant and a 19Fr Delivery System designed to allow the Expander to be deployed under direct vision for the treatment arm.
ProVee Urethral Expander System: ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
|
Sham: Ureteroscope and Urethral Access Sheath
n=71 Participants
An ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure.
Urethral Access Sheath: The Urethral Access Sheath is introduced into the prostatic urethra to simulate the placement of the ProVee Expander.
|
Crossover ProVee Urethral Expander System
n=64 Participants
All subjects shall be unblinded following the 3 month follow-up visit. Those subjects randomized to the Sham Arm will be given the opportunity to "crossover" to the ProVee Urethral Expander System.
ProVee Urethral Expander System: ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
|
|---|---|---|---|
|
Effectiveness: Number of Participants With Reduction in BPH Symptoms Compared to Sham (Time Frame: Procedure to 3 Months)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Procedure to 12 monthsPopulation: Following the 3 month follow up, 64 subjects from sham (ureteroscope and urethral access sheath) crossed over to device (the ProVee urethral expander system)
The mean percent change in IPSS in the treatment arm is at least 30% improvement over the patient's pre-treatment baseline score.
Outcome measures
| Measure |
Device: The ProVee Urethral Expander System
n=150 Participants
The ProVee Urethral Expander System consists of two components: a nitinol Expander implant and a 19Fr Delivery System designed to allow the Expander to be deployed under direct vision for the treatment arm.
ProVee Urethral Expander System: ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
|
Sham: Ureteroscope and Urethral Access Sheath
n=71 Participants
An ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure.
Urethral Access Sheath: The Urethral Access Sheath is introduced into the prostatic urethra to simulate the placement of the ProVee Expander.
|
Crossover ProVee Urethral Expander System
n=64 Participants
All subjects shall be unblinded following the 3 month follow-up visit. Those subjects randomized to the Sham Arm will be given the opportunity to "crossover" to the ProVee Urethral Expander System.
ProVee Urethral Expander System: ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
|
|---|---|---|---|
|
Effectiveness: Number of Participants With Symptoms Improvements (Time Frame: Procedure to 12 Months)
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Device: The ProVee Urethral Expander System
Serious events: 8 serious events
Other events: 1 other events
Deaths: 1 deaths
Sham: Ureteroscope and Urethral Access Sheath
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Crossover ProVee Urethral Expander System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Device: The ProVee Urethral Expander System
n=150 participants at risk
The ProVee Urethral Expander System consists of two components: a nitinol Expander implant and a 19Fr Delivery System designed to allow the Expander to be deployed under direct vision for the treatment arm.
ProVee Urethral Expander System: ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
|
Sham: Ureteroscope and Urethral Access Sheath
n=71 participants at risk
An ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure.
Urethral Access Sheath: The Urethral Access Sheath is introduced into the prostatic urethra to simulate the placement of the ProVee Expander.
|
Crossover ProVee Urethral Expander System
n=64 participants at risk
All subjects shall be unblinded following the 3 month follow-up visit. Those subjects randomized to the Sham Arm will be given the opportunity to "crossover" to the ProVee Urethral Expander System.
ProVee Urethral Expander System: ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.67%
1/150 • Number of events 1 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/71 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/64 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small bowel obstruction
|
0.67%
1/150 • Number of events 1 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/71 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/64 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.67%
1/150 • Number of events 1 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/71 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/64 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebrovascular accident
|
0.67%
1/150 • Number of events 1 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/71 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/64 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
|
Infections and infestations
Cellulitis
|
0.67%
1/150 • Number of events 1 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/71 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/64 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
|
Infections and infestations
Sepsis
|
0.67%
1/150 • Number of events 1 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/71 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/64 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.67%
1/150 • Number of events 1 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/71 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/64 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.67%
1/150 • Number of events 1 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/71 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/64 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
Other adverse events
| Measure |
Device: The ProVee Urethral Expander System
n=150 participants at risk
The ProVee Urethral Expander System consists of two components: a nitinol Expander implant and a 19Fr Delivery System designed to allow the Expander to be deployed under direct vision for the treatment arm.
ProVee Urethral Expander System: ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
|
Sham: Ureteroscope and Urethral Access Sheath
n=71 participants at risk
An ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure.
Urethral Access Sheath: The Urethral Access Sheath is introduced into the prostatic urethra to simulate the placement of the ProVee Expander.
|
Crossover ProVee Urethral Expander System
n=64 participants at risk
All subjects shall be unblinded following the 3 month follow-up visit. Those subjects randomized to the Sham Arm will be given the opportunity to "crossover" to the ProVee Urethral Expander System.
ProVee Urethral Expander System: ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
|
|---|---|---|---|
|
General disorders
Dry Mouth
|
0.67%
1/150 • Number of events 1 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/71 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
0.00%
0/64 • All subjects are followed for 3 months until the co-primary effectiveness endpoints are evaluated. After their 3-month visit, all subjects are unblinded to their treatment assignment. Subjects assigned to the ProVee Device will continue to be followed up to 60 months post implantation. Following unblinding, subjects assigned to the control arm may (crossover to the active treatment). After being treated, Crossover Subjects will be followed using the same schedule used with the ProVee Device.
Same
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place