Who is sponsoring NCT01383018?

NCT01383018 is sponsored by Boston Scientific Corporation.

What drugs are being tested in NCT01383018?

Interventions in NCT01383018: AMS Penile Prosthesis Devices.

What condition does NCT01383018 study?

NCT01383018 studies Erectile Dysfunction, Impotence.

Is NCT01383018 still recruiting?

NCT01383018 is currently completed. Last updated 12 February 2021.

Are results published for NCT01383018?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-02-12 · How we verify

NCT01383018: PROPPER

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PROPPER Prospective Registry of Outcomes With Penile Prosthesis

Completed Results posted Last updated 12 February 2021

What this trial tests

trial testing AMS Penile Prosthesis Devices in Erectile Dysfunction in 1,457 participants. Completed in 25 July 2018.

Timeline

13 June 2011

Primary endpoint
30 November 2017

25 July 2018

Quick facts

Lead sponsor	Boston Scientific Corporation
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,457
Start date	13 June 2011
Primary completion	30 November 2017
Estimated completion	25 July 2018
Sites	11 locations across Canada, United States

Drugs / interventions tested

AMS Penile Prosthesis Devices

Conditions studied

Erectile Dysfunction — all drugs for Erectile Dysfunction →
Impotence — all drugs for Impotence →

Sponsor

Boston Scientific Corporation — full company profile →

Who can join

18 and older, male only, with Erectile Dysfunction or Impotence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Penile Prosthesis Overall Subject Satisfaction Primary · 1 year, post-implantation

Penile prosthesis overall subject satisfaction (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	34
AMS 700	34
AMS Ambicor	0
Spectra	0
All AMS Penile Prosthesis Recipients - Total Reponses	37
AMS 700	35
AMS Ambicor	2
Spectra	0
All AMS Penile Prosthesis Recipients - Total Reponses	71
AMS 700	68
AMS Ambicor	2
Spectra	1
All AMS Penile Prosthesis Recipients - Total Reponses	297
AMS 700	286
AMS Ambicor	5
Spectra	6

Number of Participants With Penile Prosthesis That Are Using the Device Primary · 1 year, post implantation

Number of subjects using penile prosthesis at 1 year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	984
AMS 700	956
AMS Ambicor	18
Spectra	10

Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is. Primary · 1 year, post implantation

Penile prosthesis use at year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	58
AMS 700	56
AMS Ambicor	1
Spectra	1
All AMS Penile Prosthesis Recipients - Total Reponses	837
AMS 700	811
AMS Ambicor	17
Spectra	9

Number of Times Per Month Participants With Penile Prosthesis Are Using the Device. Primary · 1 year, post implantation

Penile prosthesis use at 1 year measured in number of times per month (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	6.3	± 5.5
AMS 700	6.3	± 5.6
AMS Ambicor	5.4	± 3.3
Spectra	5.2	± 4.3

Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use Primary · 1 year, post implantation

Penile prosthesis reasons for non-use at 1 year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	8
AMS 700	7
AMS Ambicor	1
Spectra	0
All AMS Penile Prosthesis Recipients - Total Reponses	9
AMS 700	8
AMS Ambicor	1
Spectra	0
All AMS Penile Prosthesis Recipients - Total Reponses	8
AMS 700	8
AMS Ambicor	0
Spectra	0
All AMS Penile Prosthesis Recipients - Total Reponses	17
AMS 700	17
AMS Ambicor	0
Spectra	0

Number of Participants With Penile Prosthesis Using the Device But Not as Often as Desired Primary · 1 year, post implantation

Number of penile prosthesis subjects using the device but indicated that they were not using as often as desired (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	109
AMS 700	96
AMS Ambicor	9
Spectra	4

Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied Primary · 1 year, post implantation

Reason why subject is using penile prosthesis less than desired or dissatisfied (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	4
AMS 700	4
AMS Ambicor	0
Spectra	0
All AMS Penile Prosthesis Recipients - Total Reponses	9
AMS 700	8
AMS Ambicor	0
Spectra	1
All AMS Penile Prosthesis Recipients - Total Reponses	6
AMS 700	5
AMS Ambicor	1
Spectra	0
All AMS Penile Prosthesis Recipients - Total Reponses	14
AMS 700	14
AMS Ambicor	0
Spectra	0

Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years Secondary · Baseline through 5 years

Penile prosthesis International Index of Erectile Function (IIEF-5) score (effectiveness objective 2) measured using a validated, multi-dimensional, self-administered questionnaire. Overall responses are reported. A higher score demonstrates an improvement in erectile function while a lower score indicates a loss of erectile function. The 5-question International Index of Erectile Function (IIEF-5) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical tria

Baseline

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	6.4	± 5.2

1 year

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	20.6	± 6.4

2 year

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	20.4	± 6.6

3 year

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	21.2	± 6.1

4 year

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	20.6	± 6.8

5 year

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	21.2	± 6.2

Erection Hardness Scale Over Five Years Secondary · Baseline through 5 years

The Erection Hardness Scale (EHS), an easy-to-use, four-point scale for erectile dysfunction, provides a reliable measure of erection hardness and an indicator of other health and wellbeing outcomes, according to new data reported at the European Association of Urology. EHS rates the hardness of erection on a scale of zero to four, with four being the maximal score. A higher score indicates a harder penis while a lower score indicates greater dysfunction.

Baseline

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	1.0	± 1.1

1 year

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	3.4	± 1.0

2 year

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	3.5	± 1.0

3 year

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	3.5	± 0.9

4 year

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	3.5	± 1.0

5 year

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	3.5	± 0.9

American Urology Association - Symptom Index Over Five Years Secondary · Baseline through 5 years

The AUA-SI contains seven symptoms questions which include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total score of maximum 35 points from "non-missing" items. The lower score means a better quality of life.

Baseline

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	9.0	± 6.9

1 year

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	7.9	± 6.6

2 year

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	8.8	± 7.0

3 year

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	8.2	± 6.5

4 year

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	8.1	± 6.3

5 year

Group	Value	95% CI
All AMS Penile Prosthesis Recipients - Total Reponses	8.1	± 5.7

UCLA Prostate Cancer Index Over Five Years Secondary · Baseline through 5 years

The University of California Los Angeles-Prostate Cancer Index -UCLA-PCI is a validated, twenty question questionnaire to asses impact of treatment for early stage prostate cancer on quality of life. The UCLA-PCI is analyzed in six sections, Sexual Function and Sexual Bother, Urinary Function and Urinary Bother, and Bowel Function and Bowel Bother. This is to measure not just the impact on function but also the quality of life impact. The UCLA PCI domain is scored on a scale of 0-100 points with higher values representing better outcomes.

Baseline

Group	Value	95% CI
UCLA-PCI Sexual Function	21.5	± 16.9
UCLA-PCI Urinary Function	79.9	± 24.3
UCLA-PCI Bowel Function	85.0	± 15.5
UCLA-PCI Sexual Bother	10.8	± 22.8
UCLA-PCI Urinary Bother	76.7	± 31.6
UCLA-PCI Bowel Bother	85.5	± 24.1

1 year

Group	Value	95% CI
UCLA-PCI Sexual Function	70.9	± 20.9
UCLA-PCI Urinary Function	82.6	± 20.9
UCLA-PCI Bowel Function	88.4	± 14.3
UCLA-PCI Sexual Bother	77.3	± 32.7
UCLA-PCI Urinary Bother	81.1	± 26.6
UCLA-PCI Bowel Bother	87.3	± 22.3

2 year

Group	Value	95% CI
UCLA-PCI Sexual Function	70.0	± 21.6
UCLA-PCI Urinary Function	83.4	± 20.8
UCLA-PCI Bowel Function	87.8	± 15.9
UCLA-PCI Sexual Bother	77.9	± 33.2
UCLA-PCI Urinary Bother	80.5	± 27.3
UCLA-PCI Bowel Bother	86.5	± 23.5

3 year

Group	Value	95% CI
UCLA-PCI Sexual Function	71.7	± 20.8
UCLA-PCI Urinary Function	83.8	± 21.2
UCLA-PCI Bowel Function	87.5	± 17.1
UCLA-PCI Sexual Bother	78.8	± 32.2
UCLA-PCI Urinary Bother	79.0	± 28.3
UCLA-PCI Bowel Bother	86.8	± 23.7

4 year

Group	Value	95% CI
UCLA-PCI Sexual Function	70.3	± 22.2
UCLA-PCI Urinary Function	86.0	± 19.6
UCLA-PCI Bowel Function	87.8	± 17.3
UCLA-PCI Sexual Bother	80.7	± 31.9
UCLA-PCI Urinary Bother	79.9	± 27.3
UCLA-PCI Bowel Bother	86.6	± 24.3

5 year

Group	Value	95% CI
UCLA-PCI Sexual Function	71.2	± 21.3
UCLA-PCI Urinary Function	85.9	± 21.5
UCLA-PCI Bowel Function	86.7	± 19.3
UCLA-PCI Sexual Bother	83.1	± 29.4
UCLA-PCI Urinary Bother	80.5	± 28.3
UCLA-PCI Bowel Bother	84.8	± 26.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AMS Penile Prosthesis Receipients

Serious: 36/1380 (3%)

Deaths: 44/1380

Serious adverse events (23 terms)

Reaction	System	AMS Penile Prosthesis Rece…
Device Infection	Infections and infestations	—
Erosion	Injury, poisoning and procedural complications	—
Reservoir Herniation	Injury, poisoning and procedural complications	—
Abscess	Infections and infestations	—
Hematoma	Injury, poisoning and procedural complications	—
Urinary Retention	Renal and urinary disorders	—
Pain/Discomfort	Injury, poisoning and procedural complications	—
Cardiac Event - Non-specific	Vascular disorders	—
Cellulitis	Infections and infestations	—
Cylinder Crossover	Injury, poisoning and procedural complications	—
Device Cylinder Aneruysm/Bulge	Product Issues	—
Edema - Scrotal	Skin and subcutaneous tissue disorders	—
Extrusion	Injury, poisoning and procedural complications	—
Pain/Discomfort - Penile	General disorders	—
Perforation - Other	Injury, poisoning and procedural complications	—
Peyronie's Disease	Reproductive system and breast disorders	—
Proximal Corporal Perforation	Injury, poisoning and procedural complications	—
Pulmonary Embolus	Vascular disorders	—
Urethral Obstruction	Product Issues	—
Would Dehiscence	Skin and subcutaneous tissue disorders	—
Other - Substernal Chest Pain	Cardiac disorders	—
Pain/Discomfort	General disorders	—
Other - Decreased Oxygen Saturation	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (58 terms — click to expand)

Reaction	System	AMS Penile Prosthesis Rece…
Device Infection	Infections and infestations	—
Erosion	Injury, poisoning and procedural complications	—
Reservoir Herniation	Injury, poisoning and procedural complications	—
Superficial Wound Infection	Infections and infestations	—
Urinary Retention	Injury, poisoning and procedural complications	—
Device Cylinder Aneurysm/Bulge	Product Issues	—
Urethral Trauma	Injury, poisoning and procedural complications	—
Urinary Retention	Renal and urinary disorders	—
Pain/Discomfort	General disorders	—
Extrusion	Injury, poisoning and procedural complications	—
Malposition	Product Issues	—
Hematoma	Injury, poisoning and procedural complications	—
Pain/Discomfort - Testicular	Product Issues	—
Hematoma	Injury, poisoning and procedural complications	—
Migration (pump)	General disorders	—
Pain/Discomfort - Groin	General disorders	—
Priapism	Reproductive system and breast disorders	—
Adhesion of the Pump/Scrotum	Skin and subcutaneous tissue disorders	—
Allergic reaction/Hypersensitivity Reaction	Immune system disorders	—
Auto Inflation	Product Issues	—
Bladder Neck Obstruction	Renal and urinary disorders	—
Cellulitis	Infections and infestations	—
Device Placement Failure	Injury, poisoning and procedural complications	—
Edema - Penile	Skin and subcutaneous tissue disorders	—
Fever	Investigations	—
Fibrosis	Product Issues	—
Fibrous Capsule Formation	Injury, poisoning and procedural complications	—
Hematospermia	Reproductive system and breast disorders	—
Hematuria	Renal and urinary disorders	—
Incorrect Size - Cylinders too Large	Product Issues	—
Increased Blood Loss	Vascular disorders	—
Inguinal Hernia Formation	Musculoskeletal and connective tissue disorders	—
Pain/Discomfort - Other	General disorders	—
Pain/Discomfort - Penile	General disorders	—
Pain/Discomfort With Erections	General disorders	—
Patient Dissatisfaction	General disorders	—
Perforation - Other	Injury, poisoning and procedural complications	—
Peyronie's Disease	Reproductive system and breast disorders	—
Proximal Corporal Perforation	Injury, poisoning and procedural complications	—
Urinary Tract Infection - UTI	Infections and infestations	—

Most-reported serious reactions: Device Infection, Erosion, Reservoir Herniation, Abscess, Hematoma, Urinary Retention, Pain/Discomfort, Cardiac Event - Non-specific.

Data from ClinicalTrials.gov NCT01383018 adverse events section.

Sponsor's own description

The purpose of this observational registry is to collect and better understand "real-world" outcomes for men undergoing penile implant surgery to treat erectile dysfunction.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

2018 Canadian Urological Association guideline for Peyronie's disease and congenital penile curvature.
Bella AJ, Lee JC, Grober ED, Carrier S, et al · · 2018 · cited 44× · PMID 29792593 · DOI 10.5489/cuaj.5255
Inflatable penile prosthesis implant length with baseline characteristic correlations: preliminary analysis of the PROPPER study.
Bennett N, Henry G, Karpman E, Brant W, et al · · 2017 · cited 5× · PMID 29354506 · DOI 10.21037/tau.2017.12.01
2014 CUA Abstracts
Mason R, Tanguay S, Liu Z, Kapoor A, et al · · 2014
2013 NS-AUA Abstracts
Brawer M, Cuzick J, Cooperberg M, Swanson G, et al · · 2013

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01383018 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boston Scientific Corporation
Last refreshed: 12 February 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01383018.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01383018: PROPPER

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (23 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Erectile Dysfunction

Other Boston Scientific Corporation trials

Verify against primary sources