UNBLOCS: UriNary oBstruction relieved by Laser Or Conventional Surgery

Conditions

Bothersome voiding lower urinary tract symptoms, or urinary retention, secondary to benign prostatic obstruction Urological and Genital Diseases Hyperplasia of prostate

Jo Worthington, J. Athene Lane, Hilary Taylor, Grace Young, Sian Noble et al. (15 authors)

Health Technology Assessment2020-09-0114 citations

10.3310/hta24410

Thulium laser transurethral vaporesection of the prostate versus transurethral resection of the prostate for men with lower urinary tract symptoms or urinary retention (UNBLOCS): a randomised controlled trial.

Hashim H, Worthington J, Abrams P, Young G, Taylor H, Noble SM, Brookes ST, Cotterill N, Page T, Swami KS, Lane JA, UNBLOCS Trial Group.

2020-07-0121 citations

10.1016/s0140-6736(20)30537-7

A randomised controlled trial to determine the clinical and cost effectiveness of thulium laser transurethral vaporesection of the prostate (ThuVARP) versus transurethral resection of the prostate (TURP) in the National Health Service (NHS) - the UNBLOCS trial: a study protocol for a randomised controlled trial.

Worthington J, Taylor H, Abrams P, Brookes ST, Cotterill N, Noble SM, Page T, Swami KS, Lane JA, Hashim H.

2017-04-1711 citations

10.1186/s13063-017-1916-5

Interventions

ThuVARP versus TURP in men with BPO. The trial compares conventional TURP, the current gold standard, to the new laser technique of ThuVARP. All eligible men referred for consideratio

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Adult men over the age of 18 suitable for TURP, either in urinary retention or with bothersome lower urinary tract symptoms (LUTS), secondary to BPO.

Exclusion criteria

Exclusion criteria: Patients with: 1. Neurogenic lower urinary tract dysfunction (LUTS) 2. Prostate cancer 3. Previous prostate or urethral surgery Added 08/12/2017: 4. A PSA outside of the normal age-related range and who have not had prostate cancer excluded 5. Men who are unable to give informed consent or complete trial documentation

Design outcomes

Primary

Measure	Time frame
Clinical effectiveness of ThuVARP and TURP in improving patient reported lower urinary tract symptoms (LUTS) as measured by the IPSS patient reported questionnaire and the objective measure of Qmax, 12 months after surgery.	—

Secondary

Measure	Time frame
All patient reported outcomes (PROs) will be recorded at baseline, 6 weeks (by post), 3 months and 12 months. 1. What is the cost-effectiveness of ThuVARP as compared to TURP in terms of the two primary outcomes and quality-adjusted-life-years (QALYs)? Measured using EQ-5D-5L (preference based general quality of life measure) 2. What is the comparative impact of each treatment on patient-reported LUTS, erectile function, quality of life and general health at 6 weeks after randomisation/surgery, 3 months and 12 months? Measured using the ICIQ-MLUTS (for symptom bother), International Index of Erectile Function (IIEF), ICIQ-MLUTSsex (measures of erectile function), ICIQ-LUTSqol (condition specific quality of life score), EQ-5D-5L (preference based general quality of life measure) and ICIQ-Satisfaction (measures satisfaction with surgery outcomes) to assess the full impact of the intervention on patients and the NHS. 3. What is the comparative satisfaction of men with each type of surgery? Measured using ICIQ-Satisfaction (measures satisfaction with surgery outcomes) to assess the full impact of the intervention on patients and the NHS. 4. What is the comparative effectiveness of these operations in men who present with LUTS as opposed to urinary retention? Measured using the ICIQ-MLUTS (for symptom bother), International Index of Erectile Function (IIEF), ICIQ-MLUTSsex (measures of erectile function) and ICIQ-LUTSqol (condition specific quality of life score)? 5. What are men?s experiences of both procedures, including those presenting with LUTS or urinary retention? Added 08/12/2017: Additional secondary outcomes: 1. Surgical complications is measured using Clavien-Dindo classification to 12 months post surgery 2. Length of hospital stay is measured using medical notes 3. Blood transfusion rate is measured using medical not	—

Measure

Time frame

All patient reported outcomes (PROs) will be recorded at baseline, 6 weeks (by post), 3 months and 12 months. 1. What is the cost-effectiveness of ThuVARP as compared to TURP in terms of the two primary outcomes and quality-adjusted-life-years (QALYs)? Measured using EQ-5D-5L (preference based general quality of life measure) 2. What is the comparative impact of each treatment on patient-reported LUTS, erectile function, quality of life and general health at 6 weeks after randomisation/surgery, 3 months and 12 months? Measured using the ICIQ-MLUTS (for symptom bother), International Index of Erectile Function (IIEF), ICIQ-MLUTSsex (measures of erectile function), ICIQ-LUTSqol (condition specific quality of life score), EQ-5D-5L (preference based general quality of life measure) and ICIQ-Satisfaction (measures satisfaction with surgery outcomes) to assess the full impact of the intervention on patients and the NHS. 3. What is the comparative satisfaction of men with each type of surgery? Measured using ICIQ-Satisfaction (measures satisfaction with surgery outcomes) to assess the full impact of the intervention on patients and the NHS. 4. What is the comparative effectiveness of these operations in men who present with LUTS as opposed to urinary retention? Measured using the ICIQ-MLUTS (for symptom bother), International Index of Erectile Function (IIEF), ICIQ-MLUTSsex (measures of erectile function) and ICIQ-LUTSqol (condition specific quality of life score)? 5. What are men?s experiences of both procedures, including those presenting with LUTS or urinary retention? Added 08/12/2017: Additional secondary outcomes: 1. Surgical complications is measured using Clavien-Dindo classification to 12 months post surgery 2. Length of hospital stay is measured using medical notes 3. Blood transfusion rate is measured using medical not

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Countries

United Kingdom

Outcome results

None listed