This post is for readers who are considering FLA and HoLEP.
Due to my ignorance of FLA, I have previously made comments that may be misleading. My apology. Below is new info that I have found which will correct my misleading comments.
Based on my experience, when choosing a surgical technique for BPH treatments, the important factors to consider are:
(1) retrograde ejaculation (caused by damaging tissues responsible for ejaculation located inside the prostatic urethra, such as tissues near the verumontanum, the ejaculation ducks, etc.)
(2) erectile dysfunction (controlled by two nerve bundles on the outer surface of the prostate shell)
(3) incontinence (controlled by both the internal and external sphincters, uncontrollable urination greatly affect the quality of life) ,
(4) how much it will reduce the BPH symptoms (efficacy) (the objective measures are Qmax and PVR, the subjective measures are IPSS and QoL) (for example, Urolift, FLA, RESUM will give moderate symptom relief whereas simple open prostatectomy and HoLEP will give max symptom relief, TURP is near maximum.)
(5) how long it will last(durability for example HoLEP will last 10 years and Urolift a couple of years ),
(6) scar formation (has two forms: bladder neck contracture (also called stenosis)I, urethral stricture). Both will narrow the urine channel and will block urine flow again, and
(7) other serious complications specific to the chosen technique.
BPH is caused by overgrown tissues inside the prostate. These tissues compress the prostatic urethra making it so narrow that urine can not or hard to pass through. The purpose of any BPH surgery is to open up the urethra either by removing all or a portion of the overgrown tissues(example: holep, TURP, GLL) or using mechanical means to push open the urethra (for example Urolift)
Below is my current understanding of FLA. FLA uses the same principle of REZUM: it uses heat to cause cell death in those overgrown tissues (adenoma) surrounding the prostatic urethra. However, the prostatic urethra is preserved. The dead cells do are absorbed by the body, but not right away. The treated areas are first inflamed before being absorbed. The symptoms therefore become first before they become better. After absorption, the voids, where the dead cells once were, release the compression on the urethra. This the urethra expands and as a result the diameter of urethra widens increasing the urine flow rate.
Both FLA and RESUM have a unique feature: Unlike other tranurethral procedures such as TURP, HoLEP and GLL, both FLA and REZUM do not remove the prostatic urethra, they only remove tissues located outside of the urethra. So in theory, they do not damage or injure tissues inside the urethra that are responsible for ejaculation that is no retrograde ejeculation . RESUM’s steam enters the adenoma from the urethra and does not see then nerve bundles which are located on the prostate wall whereas FLA , under MRI guidance, claims it will avoid hitting the nerve bundle. Thus, in theory, they should not cause erectile dysfunction as well. RE and ED are the major concerns for some patients seeking surgical relief. As will be given below for RESUM each is 3.1% and not zero, together is 6.2% as oppose to Urolift’s zero % for each.
I could not find any results on FLA. Since RESUM uses the same mechanism to relieve BPH, study the RESUM results will give us some idea what to expect from FLA.
I found the following most current surgical result (2018) for RESUM.
Convective radiofrequency water vapor thermal therapy for benign prostatic hyperplasia: a single office experience
Daniel Mollengarden, Kenneth Goldberg, Daniel Wong & Claus Roehrborn
Prostate Cancer and Prostatic Diseases
volume 21, pages 379–385 (2018) | Download Citation
Only 3 sections: adverse events (complications), discussion and conclusion will be given below.
“Adverse events
The most common event was UTI with rates higher with a (23.7%) than a standard urethral catheters (14.6%) (p = 0.307). These were never febrile UTIs, and it is difficult to differentiate how many of these positive cultures represent true symptomatic infections vs. postoperative LUTS with bacteriuria (Table 3).
[modified] Table 3 Adverse events following Rezūm
[Total number of patients in this study is 129
Format: n/%, n is the number of patients, % is the number of patients in percent.
UTI=urinary track infection
spanner means a stent was put in.]
UTI............................................22/17.1%
...Spanner patients...................13/23.1%
...Catheter patients.....................9/14.4%
Cystoscopic LUTS evaluation..10/7.8%
Urinary retention.......................18/14.0%
...from blood clots......................4/3.1%
...from UTI..................................1/0.8%
...from prostate edema..............13/10.1%
Urethral stricture.........................5/3.9%
Postvoid dribbling.......................5/3.9%
Urinary incontinence...................5/3.9%
Erectile dysfunction....................4/3.1%
Retrograde ejaculation...............4/3.1%
Additional BPH surgery..............3/2.3%
Prostate tissue sloughing...........2/1.6%
Epididymo-orchitis......................2/1.6%
...Bladder stone..........................1/0.8%
...Bladder neck contracture........1/0.8%
[Note by DL:
About 60% of patients suffer complications. UTI 17.1% and urinary retention 14% are very high. Urethral stricture 5% and bladder neck contracture 1%, together is 6% is also high. Post Postvoid dribbling 3.9 % and Urinary incontinence 3.9%, together is 7.8%, which is also very high. Retrograde ejaculation 3.1% and erectile dysfunction 3.1%, together is 6.2% which is not a small percentage. I was expecting both to be zero just like Urolift.］
A total of 18 patients (14.0%) had episodes of urinary retention following catheter or Spanner removal. There was no correlation between the rate of retention and either number of treatments delivered or treatment to the median lobe. Of the retention events, four patients had clot retention, one patient had a UTI, and the remaining 13 patients (10.1%) had retention presumably from postoperative prostate edema. Retention from postoperative edema occurred in 1/39 patients discharged with a Spanner (2.6%) and 12 out of 90 patients discharged with a urethral catheter (14.0%), p = 0.107.
Four patients (3.1%) required an anesthetic event after their treatment. These include a cystoscopic clot evacuation, urethral stricture balloon dilation, bladder neck contracture resection, and cystolithalopaxy. Three patients (2.3%) underwent an additional BPH surgery for persistent LUTS—two repeat Rezūm treatments and one photovaporization of the prostate. There was no strict criteria for who was offered a second Rezūm treatment.
Discussion
This patient population includes a wide range of LUTS and prostate sizes that well represents a typical urology office practice. Unlike the two prior prospective trials, the majority of these patients did not undergo medication washout periods (except the 25 patients in the Rezūm II study), and thus their results are likely more representative of usual practice patterns.
Overall, our treatment results are in line with those previously published in the two prior prospective trials [9, 10]. Those studies both demonstrated that patients reach their maximum benefit by 3 months after treatment which was confirmed in our data. Our absolute IPSS improvement of 11.6 points is slightly less than the 13.1 and 12.2 point improvements seen in the Rezūm pilot and Rezūm II pivotal studies. This is likely due to our lower initial IPSS scores and lack of medication washout periods. These are similar to results seen in meta-analyses of TUMT [11] and TUNA [12]. Notably, we found greater improvement in voiding symptoms than storage symptoms.
Our 5.9 mL/s improvement in Qmax compares to Rezūm pilot and Rezūm II pivotal trial results of 4.3 and 5.5 mL/s improvements, respectively. Our higher baseline Qmax of 10.8 mL/s likely explains the slightly higher absolute improvements compared to baselines of 8.0 and 9.9 mL/s in the other trials.
We saw no difference in outcomes based on preoperative LUTS category, median lobe treatment, or notably prostate size. This suggests a possible role in treating larger glands and merits further investigation.
Some novel information gathered was changes to prostate volume. We found a 17% prostate volume reduction based on TRUS and 14% based on PSA. The only other source of volume data comes from MRI data performed in 65 patients [8]. In that study, volumes 6 months postoperatively had decreased by a mean of 28.9% compared to volumes 1 week postoperatively. However, no data was available regarding preoperative volume, so we must question whether these 1 week volume measurements are exaggerated by postoperative edema. As expected, this is far below that expected from a TURP where the GOLIATH study a 56% reduction in prostate volume and 62% reduction in PSA at 6 months in 133 patients in its TURP arm [13]. A meta-analysis of TUNA results has shown a similar 14% volume reduction compared to our data [12].
While prior data confirms improvement in symptom scores 2 weeks out from treatment [9], anecdotally patient’s symptoms tend to worsen initially, particularly their storage symptoms. With that in mind, a Spanner Prostatic Stent was used in 35% of our patients to try and bridge past this inflammatory, edematous stage of prostate healing. Comparing patients who received a Spanner vs. a urethral catheter, there was no significant differences in IPSS or Qmax at the 91–180 day interval. There was noted a non-statistically significant increase in the UTI rate with a Spanner (23.7%) vs. a catheter (14.6%) (p = 0.31). The Spanner did result in a lower rate of retention of 2.6% compared to 14.0% with a catheter (p = 0.11), but this does not include the six patients who had the device removed prior to leaving the office for either urinary retention with the device in place. Including these patients would render a retention rate of 13.6%. Immediate retention with the Spanner may have resulted from small blood clots or postoperative prostate edema resulting in an undersized Spanner device. Ultimately, use of the Spanner was stopped due to concern for higher UTI rates and difficulties with reimbursement.
Regarding sexual function, 4 patients (3.1%) reported erectile dysfunction and 4 patients (3.1%) reported anejaculation after treatment. The anejaculation rate is in line with that reported by McVary in his subanalysis of the Rezūm II trial population where the rate was 2.9% [6]. Their group did not report any new instances of erectile dysfunction. As no assessment of baseline erectile function was performed in our patients, it is unclear whether these cases of erectile dysfunction were secondary to the treatment or simply brought to the provider’s attention at a time following the procedure.
We report a low retreatment rate with 2.3% of patients undergoing a secondary BPH surgery, though this only represents 4–12 months of follow up. Two year data from the Rezūm II and crossover populations reported a 4.3% rate (8/188 subjects) of secondary BPH surgery; however, six of their eight patients had untreated median lobes during their Rezūm procedure [5]. Treatment of all median lobes may lower that rate. Longer follow up data is still required, but so far these results are better than the retreatment rates seen in TUMT (13% in 1 year) and TUNA (20% overall) [12, 14]. [Note by DL, a reoperation rate of 4.3% over two years is very high. HoLEP reoperation rate is about 5% over 10 years.]
The main limitations of this study are its retrospective nature and the lack of a standardized follow up leading to incomplete data collection. However, the large number of patients treated and the grouping of data over time intervals allowed us to obtain sufficient data points to form meaningful conclusions.
Conclusion
To our knowledge, this represents the third data set of patients who have undergone the Rezūm convective thermotherapy treatment of the prostate. Our results mimic those seen in the prior studies with an 11.6 point improvement in IPSS and 5.9 mL/s improvement in Qmax with a reasonable side effect profile. There is a notable rate of early postoperative urinary retention which patients should be aware of. Convective radiofrequency thermotherapy of the prostate is a viable option in BPH management which is well tolerated, offers moderate symptom improvement, and may have lower retreatment rates than other available minimally invasive surgeries.”
[Note by DL: a Qmax improvement of 5.9 mL/s is considered moderate. HoLEP’s Qmax improvement is about 15 mL/s.]
DL, thanks for this informative summary.
I have had a TUMT and HoLEP. The TUMT seems to be similar to the Rezūm treatment in terms of outcomes and the lack of side effects. They both are ablative techniques. The TUMT did not produce immediate results but I personally found it very acceptable. However it only lasted 13 years.
I am not surprised about the lack of information on FLA since it is currently undergoing the first clinical trial. The report from that trial is not due until 2019-2020.
Thank you for your for all of your time and effort researching this topic.
I found the 3.1% of patients after RESUM (FLA may have the same complication) have erectile dysfunction disturbing. ED (no erection) is way more serious than RE. So I did a google search on hoLEP erectile dysfunction and found this latest study (2017). Below is the key result.
[some papers reported that HoLEP has no ED. But for this paper, studying ED was the main goal.]
Table: ED severity
Total number of patients: 459
Format: Number of patients (%)
..........................Before HoLEP .........After HoLEP
No ED.................270 (58.8%)............263 (57.3%)
Mild ED.................41 (8.9%)................63 (13.7%)
Moderate ED........24 (5.9%)................36 (7.8%)
Severe ED..........108 (23.5%)...............97 (21.1%)
[Comment by DL: (1) for the 270 patients who had no ED before HoLEP, 263 remained no ED, that is only 1.5% has ED, which could be mild, moderate or severe. For the categories of Mild, Moderate and Severe ED, actually after HoLEP, some patients became less severe that is symptom had improved.]
Free access:
jurology.com/article/S0022-5347(17)31295-8/pdf
Vol. 197, No. 4S, Supplement, Saturday, May 13, 2017
THE JOURNAL OF UROLOGY" e449
PD23-07
EFFECT OF HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) ON THE SEXUAL FUNCTION
Petr Glybochko, Yuriy Alyaev, Leonid Rapoport, Mikhail Enikeev, Dmitry Enikeev*, Nikolay Sorokin, Roman Sukhanov, Alim Dymov, Otabek Khamraev, Denis Davydov, Mark Taratkin, Moscow, Russian Federation
INTRODUCTION AND OBJECTIVES: The surgical intervention in patients with the lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH) may affect the sexual function; however modern approaches to treatment (enucleation techniques) may preserve sexual function. Holmium laser enucleation of the prostate (HoLEP) is one of them. The aim of the study was to evaluate the sexual and erectile function in patients with benign prostatic hyperplasia who were subjected to HoLEP.
METHODS: Four hundred and fifty-nine patients with benign prostatic hyperplasia (mean age 68.7 years) who experienced holmium laser enucleation of the prostate participated in the study. All the pa- tients were tested according to the International Index of Erectile Function (IIEF) to assess their sexual function, and the IPSS ? QoL scores were also determined for all the patients to evaluate the results of the operation.
RESULTS: The patient’s erectile function, ejaculation, sexual desire, and the general satisfaction with sexual intercourse were evaluated according to the IIEF. All the patients were examined both before surgery and 6 and 12 months after the operation. It is important to note that most parameter values remained virtually unchanged, although the ejaculation quality score decreased due to retrograde ejaculation in 297 patients (64.7%). Note that all the patients reported better satisfaction with sexual intercourse (from 22.1 to 23.3) that correlated with an improvement in the QoL and IPSS scores. The number of patients with complaints of erectile disorders was not increased. The effect of this surgical intervention was more pronounced in the group of patients with more severe pre-existing erectile dysfunction.
CONCLUSIONS: HoLEP results in a significant improvement in the IPSS, QoL and does not influence the values pertaining to the erectile function (IIEF). Despite the occurrence of postoperative retro- grade ejaculation in a large percentage of patients, most of them did not regard this complication as significant, which was evidenced by higher QoL and IIEF scores in the postoperative period compared with the preoperative findings. These facts allow us to characterize HoLEP as a technique that helps to preserve and, in certain cases, to improve the erectile and sexual function in patients with benign prostatic hyperplasia.
I remember that u prostate grew back to 215cc(?), but it is still excellent result.
I hope by now readers have more data to decide what is the best for them. RESUM, FLA or HoLEP?
I will be interested in following the clinical study for FLA-BPH. It looks like that technique is much more precise, in that it uses real-time MRI imaging to guide the doctor during the procedure.
Another thing that is different is that FLA-BPH is performed by an interventional radiologist not a urologist.
RESUM is done in the urologist office under local anesthesia whereas HoLEP is done in the hospital under general anesthesia and most likely FLA is same as HoLEP.
Catheter time:
For RESUM, “Postoperatively, patients were monitored with regular clinic visits. Catheters were typically removed within a week of the procedure and PVRs were monitored closely. If patients were not emptying sufficiently, a catheter would be replaced. If a Spanner was placed, it was typically continued for 2–5 weeks until the inflammatory phase of healing had passed. BPH medications were stopped once patients demonstrated adequate recovery.”
The catheter time for RESUM is about 5 days, sometime the inflamation is so bad that a stent has to be put in for 2-5 weeks, whereas for HoLEP, hospital time and catheter time together is less than a day. Don’t know about FLA, but remember a reader said he stayed in the hospital for 4-5 days after FLA and the total cost is more than $12,000.
Convective radiofrequency water vapor thermal therapy for benign prostatic hyperplasia: a single office experience
Daniel Mollengarden, Kenneth Goldberg, Daniel Wong & Claus Roehrborn
Summary of Results
“Maximal effects were noted at the 91–180 day interval. IPSS improved from a baseline of 18.3 to 6.9 and Qmax from 10.5 to 16.8 mL/s. Improvements were independent of starting symptom score, median lobe treatment, and prostate size. There was a 17% prostate volume reduction based on TRUS and 14% based on PSA. The most common adverse events were urinary tract infections (17%) and transient urinary retention (14%). In total 90% of patients were able to come off their BPH medications and 86% of patients would recommend the procedure to a friend.
....... treatments were performed on both lateral lobes starting 1 cm distal to the bladder neck and treating every 1 cm down to the level of the verumontanum, creating a contiguous zone of treatment on each lateral lobe. One to two treatments were performed on any prominent median lobes. The steam for each treatment is delivered over 9 s through a retractable needle with total procedural times generally in the 2–4 min range. Patients were discharged home with either a standard urethral catheter or a temporary Spanner Prostatic Stent (“Spanner”). The Spanner was attempted in all patients not on anti-coagulation for a period of time; however, due to difficulties properly sizing the device and concern about potentially increased urinary tract infection rates, the provider chose to return to standard urethral catheters post-procedurally. If a Spanner was placed, a voiding trial was performed prior to a patient’s discharge from clinic. If a patient was unable to void the Spanner was replaced with a urethral catheter......
.....
Of the 27 patients who had their prostate sizes measured before and six or more months after treatment, prostate size decreased from an average of 49.9 ± 17.0 SD cc to 41.0 ± 15.0 SD cc. This represents a 17.9% volume reduction from baseline. Of the 67 patients with PSA values available before and six or months after treatment, PSA decreased from an average of 2.43 ± 1.91 to 2.08 ± 1.65 SD, equaling a 14.0% decrease.”
Also I read in another sister RESUM study that the improvement in PVR is about -50 mL. This together with the Qmax improvement of 17 mL/s and the 17% prostate volume reduction based on TRUS (14% based on PSA) suggest that RESUM gives moderate relief to BPH symptoms, probably for FLA as well.
"Transurethral Resection of Prostate is Still the Gold Standard for Small to Moderate Sized Prostates
Nandan R Pujari
Department of Urology, MGM Medical College, Kamothe, Navi Mumbai, Maharashtra, India"
Year : 2016 | Volume : 3 | Issue : 2 | Page : 68-69
".........
Holmium laser enucleation of the prostate (HoLEP) has emerged as a surgical alternative to TURP. Gilling and Fraundorfer first reported about HoLEP in 1998. [7] The HoLEP technique is a method of removing the entire prostatic adenoma endoscopically. The HoLEP procedure is composed of enucleation of the prostate adenoma and morcellation of the adenoma within the bladder.
A major disadvantage of HoLEP concerns overcoming the steep learning curve. There is a higher incidence of stress urinary incontinence after HoLEP (10-15%) as compared to TURP, especially in patients with larger prostates (100 g). Surgical technique of HoLEP tends to induce a higher rate of incontinence than does TURP with the condition lasting longer. [8],[9] The duration of postoperative incontinence is usually 3-6 months. Some surgeons reported permanent incontinence. The operating time is considerably longer in HoLEP. [10] Urgency symptoms were more pronounced after HoLEP compared to TURP in a meta-analysis (5.6% vs. 2.2%). [11] The most dangerous complication that can develop in HoLEP is bladder injury during morcellation. In general, its frequency is around 10% depending on the experience of the surgeon. Other postoperative complications are transient incontinence (8.5%), urinary retention (4.3%), urinary tract infection (1.2%), and urethral stricture (0.6%). HoLEP has been around for more than 17 years but has not been able to replace TURP as the procedure of choice for small to medium sized prostates."
Found this comment on HoLEP sexual function.
Holmium laser enucleation of the prostate: surgical, functional, and quality-of-life outcomes upon extended follow-up
Ilter Alkan1
Int. braz j urol. vol.42 no.2 Rio de Janeiro Mar./Apr. 2016
dx.doi.org/10.1590/S1677-5538.IBJU.2014.0561
scielo.br/scielo.php?script=sci_arttext&pid=S1677-55382016000200293
Functional results reflected another benefit of HoLEP. Sexual functioning was neither assisted nor worsened by HoLEP. Klett et al. found that HoLEP did not adversely affect sexual function in the long-term (19). Jeong et al. reported a slight decrease in sexual functioning after operation, but this had improved 12 months later (20). However, the probability of retrograde ejaculation is 75% after operation (21). Our findings were similar with these studies (19–21). The HoLEP procedure helped to preserve sexual functions, but retrograde ejaculation still remains a problem. Improvements in voiding and sexual activity caused QoL scores to rise. Elmansy et al. reported long-term follow-up data after HoLEP (22). However, although good surgical and functional results were noted, QoL was not addressed. We have shown here that QoL improved upon long-term follow-up after HoLEP. Additionally, all improvements were maintained during long-term follow-up. Preserved functional results and improved voiding parameters are the principal findings of our present study, and constitute clinical proof of the utility of HoLEP. We strongly believe that the improvements that we recorded in various parameters reflect real clinical benefits of HoLEP.
As you have noted RE remains to be a major issue. My experience is that I no longer have much intensity.