Trial Outcomes & Findings for Optilume™ BPH Catheter System in Men With Symptomatic BPH (NCT NCT04131907)
NCT ID: NCT04131907
Last Updated: 2025-04-09
Results Overview
The primary efficacy endpoint was the improvement in International Prostate Symptom Score (IPSS) at 12 months in the Optilume BPH arm compared to the improvement in IPSS at 3 months in the Sham arm with a super-superiority margin on 25%. The IPSS contains the well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH symptoms. The first seven questions in the IPSS address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency, and scored on a 6-point scale (0 to 5). The IPSS can be interpreted as follows: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic. The IPSS also includes an eighth question that is designed to assess the degree of "bother" associated with the subject's urinary symptoms. Answers range from "delighted" to "terrible" (0-6). This question is not included in the calculation of the main IPSS score.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
162 participants
Primary outcome timeframe
12 months
Results posted on
2025-04-09
Participant Flow
162 subjects will be randomized and/or treated in the study at up to 30 clinical sites in the United States and Canada. Up to 625 subjects will be enrolled (i.e. consented) in the study in order to identify 162 eligible subjects to be randomized and/or treated. All subjects treated with the Optilume BPH Catheter System will be followed annually through 5 years. Study duration is approximately 8 years.
Any required procedures performed before obtaining informed consent as part of the standard of care may be used in lieu of the study tests. Subjects who require a washout period should have these evaluations, with the exception of informed consent, conducted following completion of the washout period. Subjects who cannot tolerate a drug washout or are considered high risk from the drug washout should be excluded from the study.
Participant milestones
| Measure |
TEST ARM - Optilume™ BPH Catheter Treatment in Men With Symptomatic BPH System
Subjects randomized to the Test arm were treated with the Optilume™ BPH Catheter System.
Subjects were evaluated at baseline, immediately post-procedure, at Foley removal, 14 days, 30 days, 3 months, 6 months, 12 months and annually through 5 years post-procedure.
Randomized subjects were blinded to the treatment assignment through the 12-month Follow-up Visit.
|
CONTROL ARM - Sham Treatment in Men With Symptomatic BPH.
Subjects randomized to the Control arm received a sham procedure. A cystoscopy was performed followed by insertion of the sham device (21 Fr Optilume BPH, Prostatic Pre-dilation Catheter with a modified catheter hub to prevent inflation of the balloon) within the sheath.
Subjects were evaluated at baseline, immediately post-procedure, at Foley removal, 14 days, 30 days, 3 months, 6 months and 12 months.
Randomized subjects were blinded to the treatment assignment through the 12-month Follow-up Visit.
Subjects randomized to the Control arm were allowed to crossover to the Test arm (treated with Optilume BPH) if they met the eligibility criteria after completing the 3-Month Follow-up Visit and prior to the close of the 12-Month visit window. Data for these subjects is reported seperately as the Crossover Cohort.
|
Pharmacokinetic (PK) Arm
Subjects in the Pharmacokinetic (PK) arm of the study were not randomized and were treated with the Optilume BPH Catheter System.
Small amounts of blood, urine and semen were collected for pharmacokinetic testing and sperm quality testing. Subjects are followed through 5-years post-procedure.
A total of 15 subjects were included in the PK arm, with one of those subjects also being included in the Crossover cohort. For this summary of the study results, 14 subjects will be indicated as participating in the PK arm to prevent the PK Crossover subject from being counted twice in the numbers.
A central core laboratory was utilized for analysis of the PK samples.
|
|---|---|---|---|
|
Overall Study
STARTED
|
100
|
48
|
14
|
|
Overall Study
Crossover Cohort
|
0
|
25
|
0
|
|
Overall Study
COMPLETED
|
90
|
26
|
12
|
|
Overall Study
NOT COMPLETED
|
10
|
22
|
2
|
Reasons for withdrawal
| Measure |
TEST ARM - Optilume™ BPH Catheter Treatment in Men With Symptomatic BPH System
Subjects randomized to the Test arm were treated with the Optilume™ BPH Catheter System.
Subjects were evaluated at baseline, immediately post-procedure, at Foley removal, 14 days, 30 days, 3 months, 6 months, 12 months and annually through 5 years post-procedure.
Randomized subjects were blinded to the treatment assignment through the 12-month Follow-up Visit.
|
CONTROL ARM - Sham Treatment in Men With Symptomatic BPH.
Subjects randomized to the Control arm received a sham procedure. A cystoscopy was performed followed by insertion of the sham device (21 Fr Optilume BPH, Prostatic Pre-dilation Catheter with a modified catheter hub to prevent inflation of the balloon) within the sheath.
Subjects were evaluated at baseline, immediately post-procedure, at Foley removal, 14 days, 30 days, 3 months, 6 months and 12 months.
Randomized subjects were blinded to the treatment assignment through the 12-month Follow-up Visit.
Subjects randomized to the Control arm were allowed to crossover to the Test arm (treated with Optilume BPH) if they met the eligibility criteria after completing the 3-Month Follow-up Visit and prior to the close of the 12-Month visit window. Data for these subjects is reported seperately as the Crossover Cohort.
|
Pharmacokinetic (PK) Arm
Subjects in the Pharmacokinetic (PK) arm of the study were not randomized and were treated with the Optilume BPH Catheter System.
Small amounts of blood, urine and semen were collected for pharmacokinetic testing and sperm quality testing. Subjects are followed through 5-years post-procedure.
A total of 15 subjects were included in the PK arm, with one of those subjects also being included in the Crossover cohort. For this summary of the study results, 14 subjects will be indicated as participating in the PK arm to prevent the PK Crossover subject from being counted twice in the numbers.
A central core laboratory was utilized for analysis of the PK samples.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
|
Overall Study
Physician Decision
|
4
|
22
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
|
Overall Study
Treatment failure
|
2
|
0
|
1
|
Baseline Characteristics
PK Arm added to Measure Analysis Population
Baseline characteristics by cohort
| Measure |
Optilume™ BPH Catheter System
n=100 Participants
The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy. The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel.
Optilume BPH Catheter System: The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy. The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel.
|
Sham Device
n=48 Participants
The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath.
Optilume Sham Device: 21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation)
|
Pharmacokinetic (PK) Arm
n=14 Participants
A single arm of 14 non-randomized subjects will be treated in the pharmacokinetics (PK) arm.
The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy.
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.5 Years
STANDARD_DEVIATION 6.4 • n=100 Participants • PK Arm added to Measure Analysis Population
|
65.5 Years
STANDARD_DEVIATION 5.6 • n=48 Participants • PK Arm added to Measure Analysis Population
|
65.6 Years
STANDARD_DEVIATION 7.4 • n=14 Participants • PK Arm added to Measure Analysis Population
|
64.8 Years
STANDARD_DEVIATION 6.2 • n=162 Participants • PK Arm added to Measure Analysis Population
|
|
Sex: Female, Male
Female
|
0 Participants
n=98 Participants • Endpoints will be analyzed using the Intent To Treat (ITT) population
|
0 Participants
n=48 Participants • Endpoints will be analyzed using the Intent To Treat (ITT) population
|
0 Participants
n=14 Participants • Endpoints will be analyzed using the Intent To Treat (ITT) population
|
0 Participants
n=160 Participants • Endpoints will be analyzed using the Intent To Treat (ITT) population
|
|
Sex: Female, Male
Male
|
98 Participants
n=98 Participants • Endpoints will be analyzed using the Intent To Treat (ITT) population
|
48 Participants
n=48 Participants • Endpoints will be analyzed using the Intent To Treat (ITT) population
|
14 Participants
n=14 Participants • Endpoints will be analyzed using the Intent To Treat (ITT) population
|
160 Participants
n=160 Participants • Endpoints will be analyzed using the Intent To Treat (ITT) population
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=100 Participants
|
3 Participants
n=48 Participants
|
0 Participants
n=14 Participants
|
16 Participants
n=162 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
87 Participants
n=100 Participants
|
45 Participants
n=48 Participants
|
14 Participants
n=14 Participants
|
146 Participants
n=162 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=100 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=162 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=100 Participants • Demographics for PK Arm
|
0 Participants
n=48 Participants • Demographics for PK Arm
|
0 Participants
n=14 Participants • Demographics for PK Arm
|
0 Participants
n=162 Participants • Demographics for PK Arm
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=100 Participants • Demographics for PK Arm
|
0 Participants
n=48 Participants • Demographics for PK Arm
|
1 Participants
n=14 Participants • Demographics for PK Arm
|
3 Participants
n=162 Participants • Demographics for PK Arm
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=100 Participants • Demographics for PK Arm
|
0 Participants
n=48 Participants • Demographics for PK Arm
|
0 Participants
n=14 Participants • Demographics for PK Arm
|
0 Participants
n=162 Participants • Demographics for PK Arm
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=100 Participants • Demographics for PK Arm
|
5 Participants
n=48 Participants • Demographics for PK Arm
|
1 Participants
n=14 Participants • Demographics for PK Arm
|
9 Participants
n=162 Participants • Demographics for PK Arm
|
|
Race (NIH/OMB)
White
|
94 Participants
n=100 Participants • Demographics for PK Arm
|
43 Participants
n=48 Participants • Demographics for PK Arm
|
12 Participants
n=14 Participants • Demographics for PK Arm
|
149 Participants
n=162 Participants • Demographics for PK Arm
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=100 Participants • Demographics for PK Arm
|
0 Participants
n=48 Participants • Demographics for PK Arm
|
0 Participants
n=14 Participants • Demographics for PK Arm
|
1 Participants
n=162 Participants • Demographics for PK Arm
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=100 Participants • Demographics for PK Arm
|
0 Participants
n=48 Participants • Demographics for PK Arm
|
0 Participants
n=14 Participants • Demographics for PK Arm
|
0 Participants
n=162 Participants • Demographics for PK Arm
|
|
Region of Enrollment
United States
|
94 participants
n=100 Participants
|
46 participants
n=48 Participants
|
14 participants
n=14 Participants
|
154 participants
n=162 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=100 Participants
|
2 participants
n=48 Participants
|
0 participants
n=14 Participants
|
8 participants
n=162 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe primary efficacy endpoint was the improvement in International Prostate Symptom Score (IPSS) at 12 months in the Optilume BPH arm compared to the improvement in IPSS at 3 months in the Sham arm with a super-superiority margin on 25%. The IPSS contains the well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH symptoms. The first seven questions in the IPSS address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency, and scored on a 6-point scale (0 to 5). The IPSS can be interpreted as follows: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic. The IPSS also includes an eighth question that is designed to assess the degree of "bother" associated with the subject's urinary symptoms. Answers range from "delighted" to "terrible" (0-6). This question is not included in the calculation of the main IPSS score.
Outcome measures
| Measure |
Optilume™ BPH Catheter System
n=100 Participants
The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy. The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel.
Optilume BPH Catheter System: The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy. The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel.
|
Sham Device
n=48 Participants
The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath.
Optilume Sham Device: 21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation)
|
|---|---|---|
|
Number of Participants With >30% Improvement in the International Prostate Symptom Score (IPSS)
|
89 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: 12 monthsRate of major device-related serious complications. A major device-related serious complication is defined as any of the following events through 12 months: * Device-related rectal fistula or GI fistula * Device-related formation of fistula between the rectum and urethra * Device-related new onset severe urinary retention lasting \> 14 consecutive days post-healing * Device-related unresolved new onset stress urinary incontinence by 90 days * Device-related bleeding requiring transfusion * Device-related urethra or prostatic capsule rupture requiring surgical intervention
Outcome measures
| Measure |
Optilume™ BPH Catheter System
n=100 Participants
The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy. The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel.
Optilume BPH Catheter System: The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy. The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel.
|
Sham Device
n=48 Participants
The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath.
Optilume Sham Device: 21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation)
|
|---|---|---|
|
Number of Participants With Major Device Related Serious Complications
|
89 Participants
|
26 Participants
|
Adverse Events
Optilume™ BPH Catheter Treatment in Men With Symptomatic BPH System
Serious events: 14 serious events
Other events: 81 other events
Deaths: 1 deaths
Sham BPH Catheter Treatment in Men With Symptomatic BPH.
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Crossover Cohort
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Pharmacokinetic(PK)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Optilume™ BPH Catheter Treatment in Men With Symptomatic BPH System
n=98 participants at risk
Subjects were randomized to treatment with the Optilume™ BPH Catheter System prior to study procedure.
|
Sham BPH Catheter Treatment in Men With Symptomatic BPH.
n=48 participants at risk
Subjects randomized are blinded to the treatment assignment through the 12-month Follow-up Visit.
|
Crossover Cohort
n=25 participants at risk
Subjects randomized to Sham who had ongoing or recurrent LUTS elected to receive the Optilume BPH Catheter System. Crossover to receive Optilume BPH was allowed before the close of the 12-month follow up period from randomization.
|
Pharmacokinetic(PK)
n=14 participants at risk
Subjects enrolled in the Pharmacokinetics arm of the study were be treated with the Optilume BPH Catheter System.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
1.0%
1/98 • Number of events 1 • 1 year
|
0.00%
0/48 • 1 year
|
0.00%
0/25 • 1 year
|
0.00%
0/14 • 1 year
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/98 • 1 year
|
2.1%
1/48 • Number of events 1 • 1 year
|
0.00%
0/25 • 1 year
|
0.00%
0/14 • 1 year
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/98 • 1 year
|
2.1%
1/48 • Number of events 1 • 1 year
|
0.00%
0/25 • 1 year
|
0.00%
0/14 • 1 year
|
|
Cardiac disorders
Myocardial Infarction
|
1.0%
1/98 • Number of events 1 • 1 year
|
0.00%
0/48 • 1 year
|
0.00%
0/25 • 1 year
|
0.00%
0/14 • 1 year
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.0%
1/98 • Number of events 1 • 1 year
|
0.00%
0/48 • 1 year
|
0.00%
0/25 • 1 year
|
0.00%
0/14 • 1 year
|
|
General disorders
Chest Pain (non cardiac
|
1.0%
1/98 • Number of events 1 • 1 year
|
0.00%
0/48 • 1 year
|
0.00%
0/25 • 1 year
|
0.00%
0/14 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple Myeloma
|
1.0%
1/98 • Number of events 1 • 1 year
|
0.00%
0/48 • 1 year
|
0.00%
0/25 • 1 year
|
0.00%
0/14 • 1 year
|
|
Nervous system disorders
Cervical Radiculopathy
|
1.0%
1/98 • Number of events 1 • 1 year
|
0.00%
0/48 • 1 year
|
0.00%
0/25 • 1 year
|
0.00%
0/14 • 1 year
|
|
Psychiatric disorders
Suicidal Depression
|
1.0%
1/98 • Number of events 1 • 1 year
|
0.00%
0/48 • 1 year
|
0.00%
0/25 • 1 year
|
0.00%
0/14 • 1 year
|
|
Renal and urinary disorders
Bladder Perforation
|
1.0%
1/98 • Number of events 1 • 1 year
|
0.00%
0/48 • 1 year
|
0.00%
0/25 • 1 year
|
0.00%
0/14 • 1 year
|
|
Renal and urinary disorders
Post Procedural Hematuria
|
4.1%
4/98 • Number of events 4 • 1 year
|
0.00%
0/48 • 1 year
|
0.00%
0/25 • 1 year
|
0.00%
0/14 • 1 year
|
|
Renal and urinary disorders
Urethral False Passage
|
1.0%
1/98 • Number of events 1 • 1 year
|
0.00%
0/48 • 1 year
|
0.00%
0/25 • 1 year
|
0.00%
0/14 • 1 year
|
|
Vascular disorders
Atherosclerosis
|
0.00%
0/98 • 1 year
|
2.1%
1/48 • Number of events 1 • 1 year
|
0.00%
0/25 • 1 year
|
0.00%
0/14 • 1 year
|
|
Vascular disorders
Pulmonary Embolism
|
1.0%
1/98 • Number of events 1 • 1 year
|
0.00%
0/48 • 1 year
|
0.00%
0/25 • 1 year
|
0.00%
0/14 • 1 year
|
Other adverse events
| Measure |
Optilume™ BPH Catheter Treatment in Men With Symptomatic BPH System
n=98 participants at risk
Subjects were randomized to treatment with the Optilume™ BPH Catheter System prior to study procedure.
|
Sham BPH Catheter Treatment in Men With Symptomatic BPH.
n=48 participants at risk
Subjects randomized are blinded to the treatment assignment through the 12-month Follow-up Visit.
|
Crossover Cohort
n=25 participants at risk
Subjects randomized to Sham who had ongoing or recurrent LUTS elected to receive the Optilume BPH Catheter System. Crossover to receive Optilume BPH was allowed before the close of the 12-month follow up period from randomization.
|
Pharmacokinetic(PK)
n=14 participants at risk
Subjects enrolled in the Pharmacokinetics arm of the study were be treated with the Optilume BPH Catheter System.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Hemorrhoids
|
5.1%
5/98 • Number of events 5 • 1 year
|
2.1%
1/48 • Number of events 1 • 1 year
|
0.00%
0/25 • 1 year
|
0.00%
0/14 • 1 year
|
|
Infections and infestations
Urinary Tract Infection
|
17.3%
17/98 • Number of events 17 • 1 year
|
12.5%
6/48 • Number of events 6 • 1 year
|
8.0%
2/25 • Number of events 2 • 1 year
|
0.00%
0/14 • 1 year
|
|
Investigations
Elevated Prostate Specific Antigen (PSA)
|
6.1%
6/98 • Number of events 6 • 1 year
|
2.1%
1/48 • Number of events 1 • 1 year
|
0.00%
0/25 • 1 year
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Bladder Spasm
|
6.1%
6/98 • Number of events 6 • 1 year
|
0.00%
0/48 • 1 year
|
0.00%
0/25 • 1 year
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Dysuria
|
9.2%
9/98 • Number of events 9 • 1 year
|
2.1%
1/48 • Number of events 1 • 1 year
|
0.00%
0/25 • 1 year
|
14.3%
2/14 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
14.3%
14/98 • Number of events 14 • 1 year
|
4.2%
2/48 • Number of events 2 • 1 year
|
0.00%
0/25 • 1 year
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Lower Urinary Tract
|
5.1%
5/98 • Number of events 5 • 1 year
|
2.1%
1/48 • Number of events 1 • 1 year
|
8.0%
2/25 • Number of events 2 • 1 year
|
0.00%
0/14 • 1 year
|
|
Renal and urinary disorders
Post Procedural Hematuria
|
30.6%
30/98 • Number of events 30 • 1 year
|
0.00%
0/48 • 1 year
|
24.0%
6/25 • Number of events 6 • 1 year
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Stress Urinary Incontinence
|
7.1%
7/98 • Number of events 7 • 1 year
|
0.00%
0/48 • 1 year
|
4.0%
1/25 • Number of events 1 • 1 year
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary Incontinence (Urge/Mixed)
|
8.2%
8/98 • Number of events 8 • 1 year
|
2.1%
1/48 • Number of events 1 • 1 year
|
16.0%
4/25 • Number of events 4 • 1 year
|
14.3%
2/14 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Urinary Urgency
|
6.1%
6/98 • Number of events 6 • 1 year
|
0.00%
0/48 • 1 year
|
0.00%
0/25 • 1 year
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Pelvic Pain
|
6.1%
6/98 • Number of events 6 • 1 year
|
2.1%
1/48 • Number of events 1 • 1 year
|
0.00%
0/25 • 1 year
|
0.00%
0/14 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place