NCT03817216 — Prostatic Urethral Lift (PUL) Pre-/Post-Radiation Treatment for Prostate Cancer · CancerIndex

Clinical trial · Interventional

Prostatic Urethral Lift (PUL) Pre-/Post-Radiation Treatment for Prostate Cancer

Prostatic Urethral Lift (PUL) Pre-/Post-Radiation Treatment for Prostate Cancer: Prospective Analysis of Outcomes in Patients With Obstructive Urinary Symptoms

NCT03817216CI-TRIAL-00043993withdrawnN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): re-written and submitted as a new study

Summary

Brief summary (as posted)

The purpose of this study is to test the use of the Prostatic Urethral Lift (PUL), Urolift®, in prostate cancer (Pca) participants seeking or undergoing radiotherapy for relief of urinary obstructive symptoms.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Benign Prostatic Hyperplasia (BPH)	Benign Prostatic Hyperplasia	ALIAS	0.90
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Prostatic Urethral Lift (PUL)	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
Prostatic Urethral Lift (PUL) post-EBRT
description
Prostatic Urethral Lift (PUL) following External Beam Radiotherapy (EBRT)
interventionNames
1. Device: Prostatic Urethral Lift (PUL)
type
EXPERIMENTAL
label
Prostatic Urethral Lift (PUL) pre-BT
description
Prostatic Urethral Lift (PUL) preceding Brachytherapy (BT)
interventionNames
1. Device: Prostatic Urethral Lift (PUL)
type
ACTIVE_COMPARATOR
label
Prostatic Urethral Lift (PUL) post-BT
description

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 51 Years

Show eligibility criteria text

Inclusion Criteria:

* International Prostate Symptom Score ≥ 12.
* Peak flow rate ≤ 12 ml/sec with at least 125 ml voided urine.
* Prostate volume ≤ 80 cc as measured either by trans-rectal ultrasound (US) or Magnetic Resonance Imaging (MRI).

Exclusion Criteria:

* Obstructive median lobe of the prostate.
* Active urinary tract infection.
* Neurogenic non-obstructive voiding dysfunction.
* Obstructive symptoms secondary to prostate cancer (via cystoscopy).
* Patients with prior Transurethral resection of the prostate (TURP).
* Patients with prior history of urethral stricture.

References

Publications (0)

Data not yet available

No reference posted for this study.

Primary outcomes (2)

measure
Mean change in International Prostate Symptom Score (IPSS) - Arms: PUL placement post-EBRT and PUL placement post-BT
timeFrame
3 months post-PUL placement
description
IPSS is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia. A mean change in International Prostate Symptom Score (IPSS) will be considered effective if the following condition is met: ≥ 30% or ≥ 4 point IPSS reduction 3 months after PUL.
measure
Mean change in International Prostate Symptom Score (IPSS) - Arm: PUL placement pre-BT.
timeFrame
3 months post-BT
description
IPSS is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia. A mean change in International Prostate Symptom Score (IPSS) will be considered effective if the following condition is met: * 30% or ≥ 4 point IPSS reduction 3 months after BT from pre-PUL baseline.

Secondary outcomes (10)

measure
Mean change in International Prostate Symptom Score (IPSS)
timeFrame
6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description
IPSS is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia. Mean change in IPSS score will be reported
measure
Mean change in peak urinary flow rate (Qmax)
timeFrame
6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description
Qmax is the quantity of urine measured over a specified period of time. A significant outcome would be a greater than 50% change in Qmax.
measure
Quality of life scores from last question on IPSS questionnaire
timeFrame
6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description
QOL score (last question in the IPSS questionnaire): If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? With answer options on a 0-6 scale with 0 being delighted and 6 being terrible.
measure
Mean change in Benign Prostatic Hyperplasia Impact Index (BPHII) scores
timeFrame
6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description
The Benign Prostatic Hyperplasia Impact Index (BPHII) is a self-administered questionnaire with four questions about urinary problems during the past month regarding physical discomfort, worry about health, how bothersome symptoms are, and whether the symptoms are interfering with doing usual activities. Mean change in BPHII score will be reported.
measure
Mean change in the MSHQ total score
timeFrame
6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description
Men's Sexual Health Questionnaire (MSHQ) is a 18-item questionnaire focused on assessing three core function domains (erection, ejaculation and satisfaction). Mean change in the MSHQ ejaculation total score will be reported.
measure
Urinary incontinence measured by number of pads used
timeFrame
6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description
Assessment of urinary incontinence associated with the procedure measured by change number of pads used per day.
measure
Urinary incontinence measured by quality of stress or urge
timeFrame
6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description
Assessment of urinary incontinence associated with the procedure as measured by quality: stress or urge.
measure
Urinary incontinence measured by cough stress test
timeFrame
6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description
Assessment of urinary incontinence associated with the procedure as measured by cough test.
measure
Urinary incontinence measured by time to resolve
timeFrame
6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description
Assessment of urinary incontinence associated with the procedure as measured by time to resolve.
measure
Mean change in post-void residual (PVR)
timeFrame
3, 6, and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms
description
Assessment of PVR, the amount of urine left in the bladder after urination.