Interventional procedure consultation document

Insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia

Prostatic urethral lift implants to treat lower urinary tract symptoms in benign prostatic hyperplasia

Benign prostatic hyperplasia is a condition that causes the prostate to increase in size. It can lead to the prostate squeezing the tube that carries urine from the bladder to the tip of the penis (the urethra). This can cause problems with passing urine. Prostatic urethral lift implants are permanently fitted in the prostate to open up the narrowed or blocked urethra by lifting or holding the enlarged prostate out of the way.

The National Institute for Health and Care Excellence (NICE) is examining insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of specialist advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

·       comments on the provisional recommendations

·       the identification of factual inaccuracies

·       additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

·       The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.

·       The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website.

Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 20 September 2013

Target date for publication of guidance: January 2014

 

 

 

1                      Provisional recommendations

 

1.1                  Current evidence on the efficacy and safety of insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit.

 

1.2                  During the consent process clinicians should, in particular, advise patients about the range of possible treatment options and the possible need for further procedures if symptoms recur.

 

1.3                  The procedure should only be carried out by clinicians with specific training in the insertion of prostatic urethral lift implants.

 

1.4                  NICE encourages further research and publication of results from consecutive case series of patients having this procedure. Details of patient selection should be clearly documented. Reported outcomes should include the effects of the procedure on symptoms and quality of life, the duration of benefits, and the need for further procedures. All complications should be reported. NICE may review this procedure in the light of longer-term outcomes.

 

2                      Indications and current treatments

 

2.1                  Benign prostatic hyperplasia is a common condition that affects older men. It is characterised by an increase in the size of the prostate, which is caused by an increased number of stromal and epithelial cells. Benign prostatic hyperplasia can cause lower urinary tract symptoms including hesitancy during micturition, interrupted or decreased urine stream, nocturia, incomplete voiding and urinary retention.

 

2.2                  Mild symptoms are usually managed conservatively. Drugs such as alpha blockers and anti-androgens can be used. If symptoms are more severe, then surgical treatments may be used including transurethral resection of the prostate (TURP), transurethral vaporisation of the prostate, or holmium laser enucleation of the prostate (see The management of lower urinary tract symptoms in men [NICE clinical guideline 97]).

 

3                      The procedure

3.1                  The aim of insertion of prostatic urethral lift implants for lower urinary tract symptoms secondary to benign prostatic hyperplasia is to widen the lumen of the urethra by retracting the enlarged prostate lobes. The procedure is designed to cause less tissue injury than surgical resection or thermal ablation, and it is claimed to reduce the risk of complications such as sexual dysfunction and incontinence.

 

3.2                  The procedure is undertaken transurethrally with the patient under local or general anaesthesia. A pre-loaded delivery device is passed through a rigid sheath under cystoscopic visualisation. The delivery device is used to compress 1 lateral lobe of the prostate in an anterolateral direction towards the prostatic capsule. A needle is then advanced through the lobe and capsule, and a monofilament implant with 2 end pieces is deployed. One end of the implant is anchored in the urethra and the other on the outer surface of the prostatic capsule, retracting the prostatic lobe away from the urethral lumen. Multiple implants are usually inserted during the same procedure.

4                      Efficacy

 

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

 

4.1                  In a randomised controlled trial (RCT) of 206 patients, 140 patients treated by prostatic urethral lift (PUL) compared against 66 patients treated by a sham procedure, there was a significant difference in mean change in American Urological Association Symptom Index (AUASI) score (scores range from 0 to 35; higher score indicating greater severity) at 3-month follow-up. The mean score decreased by 11 points at follow-up from a baseline score of 22 in patients treated by PUL and by 6 points at follow-up from a baseline score of 24 in patients treated by the sham procedure (p=0.003 difference between the groups).

 

4.2                  A case series of 64 patients reported a significant improvement in International Prostate Symptom Score (scale 0 to 35; higher score indicating more severe symptoms) between 2 weeks and 24 months after treatment. The mean score improved from 22 at baseline to 13 at 2 year follow up (n=33; p<0.001).

 

4.3                  The RCT of 206 patients reported a significant difference in change in AUASI quality of life scores (scale 0 to 5; higher score indicating lower quality of life) at 3 months. The mean quality of life score decreased from 5 to 2 in patients treated by PUL and from 5 to 4 in patients treated by the sham procedure (p<0.001 difference between the groups).

 

4.4                  The case series of 64 patients reported Sexual Health Inventory for Men scores (scale assesses erectile dysfunction, with scores ranging from 1 to 25, with 1 being the most severe and 25 being healthy). There was a statistically significant improvement in score in 26 patients (for whom results were reported), from 18 at baseline to 20 at 1 year follow up (p=0.01).

 

4.5                  The RCT of 206 patients reported a significant improvement in mean urinary flow rate at 3 months. The mean improvement in urinary flow was 4 ml/s in patients treated by PUL and 2 ml/s in patients treated by the sham procedure (from 8 ml/s at baseline for both groups; p=0.005 difference between the groups).

 

4.6                  A case series of 19 patients reported a significant reduction in mean post-voiding residual volume, from 147 ml at baseline to 46 ml at 3 month follow up (n=11; p=0.01).

 

4.7                  The RCT of 206 patients reported retreatment at 1 year in 5% (7/140) of patients treated by PUL. Five patients underwent further PUL treatment because of insufficient response and 2 patients were treated by transurethral prostate resection (TURP) or laser vaporisation (reasons for retreatment not reported). The case series of 64 patients reported that 20% (13/64) of patients had further procedures. Four patients had TURP or photoselective vaporisation of the prostate within 7 months. Nine patients with symptomatic improvement after the initial procedure had TURP (n=4), photoselective vaporisation (n=4) or PUL (n=1) (at a mean of 13 months after the procedure) because of recurrent lower urinary tract symptoms.

 

4.8                  The specialist advisers listed key efficacy outcomes to be symptom improvement, improvement in quality of life, reducing or stopping medical therapy, flow improvement, reduction in post void residual volume and maintenance of sexual and ejaculatory function.

 

5                      Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

 

5.1                  Urinary tract infections (within 3 months of the procedure) were reported in 3% (4/140) of patients treated by prostatic urethral lift (PUL) and 2% (1/66) of patients treated by a sham procedure in the randomised controlled trial (RCT) of 206 patients (level of significance not reported).

 

5.2                  Orchitis was reported in 3% (3/102) of patients in a case series of 102 patients (duration and timing not reported).

 

5.3                  Symptoms of prostatitis (penile and perineal discomfort, pain on erection and ejaculation) were reported in 1 patient in the case series of 64 patients (treated with antibiotics).

 

5.4                  Urinary retention (within 30 days of the procedure) was reported in 16% (3/19) of patients in the case series of 19 patients (reported as lasting median 3.5 days; no further details given).

 

5.5                  Transient urge incontinence was reported in 8% (5/64) of patients in the case series of 64 patients (resolved within 8 days).

 

5.6                  Incomplete voiding (within 30 days of the procedure) was reported in 1 patient in the case series of 19 patients (lasting 42 days).

 

5.7                  Erectile dysfunction was reported within 30 days of the procedure in 11% (2/19) of patients in the case series of 19 patients. This spontaneously resolved after 23 days in 1 patient and 127 days in the other patient.

 

5.8                  The specialist advisers listed bleeding, prostatic swelling, and retention (needing catheterisation) as anecdotal adverse events. The specialist advisers considered vascular and rectal injury to be theoretical adverse events.

 

6                      Committee comments

 

6.1              The Committee recognised that implantation of prostatic urethral lift implants is not likely to offer permanent relief of symptoms, but that some patients may prefer it to other procedures which have a greater risk of causing sexual dysfunction. Certain patients may also prefer this procedure to prolonged drug therapy.

 

7                      Further information

 

7.1                  For related NICE guidance see the NICE website.

 

_{Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.}

 _{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}

 

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

August 2013