Phase
Condition
Prostate Disorders
Bladder Disorders
Treatment
Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts
Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohorts
Clinical Study ID
Ages > 50 Male
Study Summary
Eligibility Criteria
Inclusion
● The PUL and TURP/LASER cohorts:
Inclusion criteria:
male patient aged over 50 years
patient who experienced a PUL or TURP/Laser surgery in first line of treatment for asymptomatic BPH, with an International Prostatic Symptom Score > 13, a Peak urineflow rate < 12ml/sec on a voided volume >150ml a Prostate volume >30cc to <80 cc perultrasound.
patient affiliated to a French health insurance system
Exclusion
Exclusion criteria:
Patient with current urinary retention, post void residual urine > 250ml,
Patient with active urinary tract infection at time of treatment,
Patient with previous Benign Prostatic Hyperplasia procedure,
Patient with urethral conditions that may prevent insertion and delivery of devicesystem into bladder,
Patient with previous pelvic surgery or irradiation,
Patient with history of neurogenic or atonic bladder,
Patient with biopsy of the prostate within the past 6 weeks,
Patient with life expectancy estimated to be less than 1 year,
Patient with history of prostate or bladder cancer,
Patient with PSA>10ng/ml unless prostate biopsy is negative,
Patient under guardianship or curatorship,
Patient intending to move abroad within 1 year after inclusion will not be includedeither,
Patient participating to another interventional study on benign prostatichyperplasia during the study.
The SNDS cohort:
Inclusion criteria:
male patient affiliated to a French health insurance system
patient aged over 50 years
patient who experienced a TURP/Laser surgery in first line of treatment for asymptomatic BPH in the same period as patients of the PUL and TURP/LASER cohorts.
Exclusion criteria:
Patients hospitalized in one of the 6 investigational centers and patients with aprevious BPH procedure,
patient with a previous pelvic surgery or irradiation,
patient with history of prostate or bladder cancer within the 2 previous years,
patient with a biopsy of the prostate within the past 6 weeks,
patient with a short life expectancy will not be included in the cohort.
Study Design
Study Description
Connect with a study center
Hôpital Claude Huriez
Lille, 59037
FranceSite Not Available
CHU de Montpellier
Montpellier,
FranceSite Not Available
Hôpital Cochin
Paris,
FranceSite Not Available
Hôpital Lyon Sud HCL
Pierre-Bénite,
FranceSite Not Available
Centre Hospitalier Universitaire de Bordeaux
Talence,
FranceSite Not Available
CHRU Hopitaux de Tours
Tours,
FranceSite Not Available
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