Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Economic Evaluation of Prostatic Urethral Lift (ECOLIFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04726748
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : February 7, 2022
Sponsor:
Collaborator:
Bordeaux PharmacoEpi
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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).


Condition or disease Intervention/treatment
Benign Prostatic Hyperplasia Procedure: Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohorts Procedure: Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts

Detailed Description:

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).

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1360 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Economic Evaluation of Prostatic Urethral Lift (Urolift)
Actual Study Start Date : April 8, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Urolift cohort
80 patients with prostatic urethral lift surgery will be included
 Procedure: 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.

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.
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.
 Procedure: 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.
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.
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incremental cost per avoided complication [ Time Frame: 4 months after the date of surgical procedure ]
    Incremental cost per avoided complication (based on Clavien Dindo classification) of Prostatic Urethral Lift compared with classic transurethral surgery (TURP/laser) 4 months after the surgical procedure.


Secondary Outcome Measures :
  1. Incremental cost per Quality adjusted life year [ Time Frame: 12 months after the date of surgical procedure ]
    The incremental cost per Quality adjusted life year of Prostatic Urethral Lift compared with classic transurethral surgery at 12 months.

  2. Overall and specific urogenital healthcare consumptions [ Time Frame: during 3 years after surgical procedure date ]

    Description of the overall and specific urogenital healthcare consumptions during the 3 years of follow-up.

    Means will be compared between two independent groups using Student's t-test when normal distribution is followed (or Mann-Whitney's test when normal distribution is not followed)


  3. Benign prostatic hyperplasia retreatment [ Time Frame: 12 months after surgical procedure date ; 36 months after surgical porcedure date ]
    Any dispensing of the following medications at 1 and 3 years after surgical procedure: alpha-blockers or 5-alpha-reductase inhibitors.

  4. Urinary incontinence evolution [ Time Frame: Inclusion date (date of the surgical procedure completion) ; 4 months after surgical procedure ]
    Urinary incontinence evolution between inclusion and 4 months after surgical procedure (Incontinence Severity Index (ISI)).

  5. Sexual quality of life evolution [ Time Frame: Inclusion date (date of the surgical procedure completion) ; 4 months, 12 months after surgical procedure ]
    Sexual quality of life evolution between inclusion, 4 months and 12 months after surgical procedure (IIEF5, Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Sampling Method:   Non-Probability Sample
Study Population
Patients of the PUL and TURP/LASER cohorts will be identified in the SNDS through their NIR national identifier (if possible) or using a probabilistic linkage with age, hospital identifier (FINESS), date of hospitalization for the procedure and International Classification of Diseases-10 discharge diagnosis. Only patients with a 2-year history before the procedure and a 3-year follow-up after the procedure will be analysed.
Criteria

● 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 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

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:

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 a symptomatic 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 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04726748


Contacts
Layout table for location contacts
Contact: Grégoire Robert 05.57.82.06.87 gregoire.robert@chu-bordeaux.fr
Contact: Meric BENBOUJEMA 05.57.82.06.87 meric.ben-boujema@chu-bordeaux.fr

Locations
Layout table for location information
France
Hôpital Claude Huriez Recruiting
Lille, France, 59037
Contact: Arnauld VILLERS    03 20 44 42 35    arnauldvillers@me.com   
CHU de Montpellier Recruiting
Montpellier, France
Contact: Thibaut MUREZ       t-murez@chu-montpellier.fr   
Hôpital Cochin Recruiting
Paris, France
Contact: Nicolas BARY DELONGCHAMPS    0158412783    nicolas.barrydelongchamps@aphp.fr   
Hôpital Lyon Sud HCL Recruiting
Pierre-Bénite, France
Contact: Alain RUFFION       alain.ruffion@chu-lyon.fr   
Centre Hospitalier Universitaire de Bordeaux Recruiting
Talence, France
Contact: Grégoire ROBERT    05.57.82.06.87      
Contact: Meric BEN BOUJEMA    05.57.82.06.87    meric.ben-boujema@chu-bordeaux.fr   
CHRU Hopitaux de Tours Recruiting
Tours, France
Contact: Franck BRUYERE    0247473917    F.BRUYERE@chu-tours.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
Bordeaux PharmacoEpi
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04726748    
Other Study ID Numbers: CHUBX 2019/12
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases