Economic Evaluation of Prostatic Urethral Lift

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-08

Study Completion Date

2025-12-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prostatic urethral lift (Urolift) has been developed as a minimally invasive alternative to transurethral resection of the prostate with no need of general anaesthesia, less need of urinary catheter and less exposure to post-operative complication. Its efficacy and safety have been assessed by 2 clinical randomized trials with evidence of urinary symptom improvement remaining inferior to TURP but durable for 5 years. Urolift preserved overall quality of life better than TURP. Urolift has been recommended by the European Association of Urology guidelines and recognized by French authorities but cannot be financed by the hospital itself. Reimbursement of the implants by healthcare system is therefore needed for the distribution of Urolift in France.

The additional cost of the implants could be compensated by a reduced length of hospital stay and a lower rate of post-operative complications inducing healthcare expenditures. This study aims to assess if Urolift could be a cost-effective therapeutic strategy compared to transurethral surgery with 2 phases design: a field study comparing patients treated with Urolift to those treated with TURP/laser during 1 year follow-up, and an additional study comparing healthcare consumptions during 3 years follow-up between each group using data of the French National Claims Database (SNDS database).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prostatic Urethral Lift in Subject With Acute Urinary Retention

NCT03194737

Acute Urinary Retention Benign Prostatic Hyperplasia

COMPLETED NA

Innovative Minimally Invasive Options in Treatment of Urinary Problems Related to Prostate Enlargement (BPH) in Men

NCT03043222

Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia Urinary Frequency/Urgency +3 more

WITHDRAWN NA

Office Based Transperineal Laser Ablation for Benign Prostatic Hyperplasia HYPERPLASIA

NCT04760483

Male Urogenital Diseases Genital Diseases, Male Prostatic Disease +1 more

ACTIVE_NOT_RECRUITING PHASE1

Registry: TPLA for LUTS

NCT03776006

Lower Urinary Tract Symptoms Benign Prostate Hyperplasia Benign Prostatic Hypertrophy With Outflow Obstruction

NOT_YET_RECRUITING

Efficacy of Prostatic Artery Embolization (PAE) in Patients With Severe Benign Prostatic Hyperplasia (BPH)

NCT02167919

Benign Prostatic Hyperplasia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Transurethral surgery such as transurethral resection of the prostate (TURP), laser enucleation or laser vaporisation, is the first line surgical treatment for bladder outlet obstruction secondary to benign prostatic hyperplasia. Even if bipolar and laser surgery have improved surgical outcomes in terms of length of hospital stay and post-operative complications, these procedures remain associated with a significant amount of infectious and bleeding complications, as well as with some persistent side effects such as sexual dysfunction and urinary incontinence.

Prostatic urethral lift (Urolift) has been developed as a minimally invasive alternative to TURP with no need of general anaesthesia, less need of urinary catheter and less exposure to post-operative complication. Its efficacy and safety have been assessed by 2 clinical randomized trials with evidence of urinary symptom improvement remaining inferior to TURP but durable for 5 years. Urolift preserved overall quality of life better than TURP. Urolift has been recommended by the European Association of Urology guidelines and recognized by French authorities but cannot be financed by the hospital itself. Reimbursement of the implants by healthcare system is therefore needed for the distribution of Urolift in France.

The additional cost of the implants could be compensated by a reduced length of hospital stay and a lower rate of post-operative complications inducing healthcare expenditures. This study aims to assess if Urolift could be a cost-effective therapeutic strategy compared to transurethral surgery with 2 phases design: a field study comparing patients treated with Urolift to those treated with TURP/laser during 1 year follow-up, and an additional study comparing healthcare consumptions during 3 years follow-up between each group using data of the French National Claims Database (SNDS database).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Benign Prostatic Hyperplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Urolift cohort

80 patients with prostatic urethral lift surgery will be included

Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohorts

Intervention Type PROCEDURE

Comparison between the PUL and the TURP/Laser cohorts will be performed after 1 year and 3 years of follow-up in a intention-to-treat analysis using:

* a linear regression model when it involves quantitative variables,
* a logistic regression model adjusted on potential confounding when it involves qualitative variables.

Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts

Intervention Type PROCEDURE

Comparison between the PUL and the SNDS cohorts will be performed after 1 year and 3 years of follow-up in a intention-to-treat analysis using:

* a linear regression model when it involves quantitative variables,
* a logistic regression model adjusted on potential confounding when it involves qualitative variables.

Transurethral Resection of the Prostate/laser cohort

80 patients with a transurethral resection of the prostate or laser surgery (enucleation or vaporisation) will be included.

Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohorts

Intervention Type PROCEDURE

Comparison between the PUL and the TURP/Laser cohorts will be performed after 1 year and 3 years of follow-up in a intention-to-treat analysis using:

* a linear regression model when it involves quantitative variables,
* a logistic regression model adjusted on potential confounding when it involves qualitative variables.

National healthcare insurance system database (SNDS) cohort

1200 patients with any transurethral surgery (TURP/laser) will be included and randomly matched to patients of the Urolift cohort with ratio 5:1.

Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts

Intervention Type PROCEDURE

Comparison between the PUL and the SNDS cohorts will be performed after 1 year and 3 years of follow-up in a intention-to-treat analysis using:

* a linear regression model when it involves quantitative variables,
* a logistic regression model adjusted on potential confounding when it involves qualitative variables.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohorts

Comparison between the PUL and the TURP/Laser cohorts will be performed after 1 year and 3 years of follow-up in a intention-to-treat analysis using:

* a linear regression model when it involves quantitative variables,
* a logistic regression model adjusted on potential confounding when it involves qualitative variables.

Intervention Type PROCEDURE

Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts

Comparison between the PUL and the SNDS cohorts will be performed after 1 year and 3 years of follow-up in a intention-to-treat analysis using:

* a linear regression model when it involves quantitative variables,
* a logistic regression model adjusted on potential confounding when it involves qualitative variables.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* male patient aged over 50 years
* patient who experienced a PUL or TURP/Laser surgery in first line of treatment for a symptomatic BPH, with an International Prostatic Symptom Score \> 13, a Peak urine flow rate \< 12ml/sec on a voided volume \>150ml a Prostate volume \>30cc to \<80 cc per ultrasound.
* patient affiliated to a French health insurance system

* 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 a symptomatic BPH in the same period as patients of the PUL and TURP/LASER cohorts.

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 device system 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 included either,
* Patient participating to another interventional study on benign prostatic hyperplasia during the study.

* The SNDS cohort:

* Patients hospitalized in one of the 6 investigational centers and patients with a previous 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.

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No