Ignite Creation Date:
2024-05-06 @ 8:24 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02737241
Status:
COMPLETED
Last Update Posted:
2018-04-03
First Post:
2016-03-27
Brief Title:
HoLEP 50W vs HoLEP 100W for Treatment of BPH
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Randomized Clinical Trial Comparing Low Power 50W Holmium Laser Enucleation of the Prostate HoLEP Versus High Power 100W HoLEP
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HoLEP Holmium laser enucleation of the prostate entails dissection of the whole median and lateral prostatic lobes off the surgical capsule via a retrograde approach starting at the apex The enucleated lobes were pushed to the bladder followed by hemostasis of the prostate bed then intravesical morcellation of the enucleated adenoma
The investigators are going to compare safety and efficacy of low power LP-HoLEP vs high power HP-HoLEP in treatment of infra-vesical obstruction secondary to BPH Benign prostate Hyperplasia
The investigators are going to compare safety and efficacy of low power LP-HoLEP vs high power HP-HoLEP in treatment of infra-vesical obstruction secondary to BPH Benign prostate Hyperplasia
Detailed Description:
Introduction
Benign prostatic hyperplasia BPH is a pathologic process that contributes to but is not the sole cause of lower urinary tract symptoms LUTS in aging men
The decision to intervene is frequently used as an end point after failure of different medical therapies These medications are able to delay this point Failed medical treatment either due to refractory LUTS or in patients who are not willing to make a lifetime commitment to medical therapy represents one indication to intervene
Urine retention secondary to BPH with failed voiding trial without catheter is an indication for intervention in healthy individuals as well as recurrent hematuria secondary vesical stones and recurrent urinary tract infection Renal deterioration secondary to BPH is an indication of intervention after proper evaluation of the bladder function
For years surgical treatment for BPH was transurethral resection of the prostate TURP for small to moderate sized prostate and open prostatectomy OP for markedly enlarged one
Laser prostatectomy was introduced as a less invasive modality for treatment of BPH overcoming the disadvantages and limitations of the traditional standard TURP and OP It seems to be advantageous as it is less invasive than OP Furthermore using physiological saline as an irrigant with higher safety profile in morbid patients who have to be on anticoagulants or antiplatelet during surgery It is used to tackle larger prostate glands beyond the limits of TURP It is not infrequent to be done as day surgery with shortened catheterization time
Eventually it seems to be cost effective however the remaining concern as in all minimally invasive surgeries MIS is the durability and reoperation rates Despite the significant advantages known with laser prostatectomy techniques particularly HoLEP adoption of these procedures in urologic community is limited and one of the causes is the high initial cost investment for laser capital equipment
HoLEP entails dissection of the whole median and lateral prostatic lobes off the surgical capsule via a retrograde approach starting at the apex The enucleated lobes were pushed to the bladder followed by hemostasis of the prostate bed then intravesical morcellation of the enucleated adenoma
Over the past 15 years different technical modifications have come out to the procedure However all the current reports use 100 watt laser power High power HoLEP HP-HoLEP for the laser assisted enucleation technique
Khan et al 2015 reported on the feasibility of using low power LP-HoLEP for safe and effective HoLEP The authors cut significantly on the initial cost of laser capital equipment They used 50-watt holmium laser machine to accomplish the enucleation procedure with reasonable efficacy Nevertheless there are no randomized studies assessing safety efficacy and cost saving associated with LP-HoLEP
Aim of the Work
This study aims to compare safety and efficacy of LP-HoLEP vs HP-HoLEP in treatment of infra-vesical obstruction secondary to BPH
Patients and Methods
Study design Randomized Controlled Trial RCT
Study population
BPH surgical candidates presented to the outpatient clinic of the prostate unit in the urology department Urology nephrology center Mansoura University will be assessed to evaluate if these patients are eligible to the study inclusion criteria
BPH surgical candidates are patients presented with LUTS secondary to BOO bladder outlet obstruction due to BPH who failed medical treatment IPSS international prostate symptom score score 15 peak urinary flow rate Qmax 15 mlsec recurrent attacks of urine retention with failed trial voiding patients with hematuria of prostatic origin with failed medical treatment and patients with vesical stone secondary to BPH
Preoperative work up
All patients will be thoroughly evaluated by medical history and physical exam digital rectal exam DRE prostate specific antigen PSA urinalysis and urine culture international index of prostate symptom score IPSS transrectal ultrasound TRUS measurement of prostatic volume and biopsy whenever indicated measurement of post-void residual assessment PVR and maximum urinary flow rate Qmax Patients with positive urine culture will be treated accordingly
Randomization
Patients will be randomly assigned to the study groups on the day of the surgery after signing the informed consent for participation in the study The randomization process will be performed using computer-generated random tables in a 11 ratio A stratified-blocked randomization across two strata derived from predetermined size grouping 40-80 ml and more than 80 ml and two strata derived from preoperative indication catheterized and non-catheterized were done This method ensures parity among the two treatment groups In each stratum given two possible block lengths of four and eight respectively with a random number generator giving numbers uniformly distributed between 0 and 1 the investigators selected a block length of four for random numbers lower than 05 or a block length of eight otherwise Variation of the block sizes prevented the surgeon from guessing what the next treatment will be it makes it difficult although not impossible to break the treatment code
Eligible patients will be randomized into one of two groups
Group 1 50 patients Patients will be managed with HP-HoLEP Group 2 50 patients Patients will be managed with LP-HoLEP
Procedure
In case of coexisting urinary bladder stone Holmium laser cystolithotripsy will be done first
Laser setting
HP-HoLEP Energy2 Joule Rate50 Hertz for adenoma enucleation reduced to Energy15 Rate30 for apical dissection hemostasis
LP-HoLEP Energy2 Joule Rate25 throughout the whole procedure
Surgical Technique
HoLEP can be divided into four phases inspection enucleation hemostasis and morcellation Briefly a plane was created between the adenoma and the surgical capsule early after the first incision of the gland from the bladder neck to the level of the verumontanum The gland was enucleated in two or three lobes depending on the anatomy and the prominence of the grooves on either side of the middle lobe
The Two-lobe technique starts with a 5- or 7-Oclock incision in a groove between the median lobe and one lateral lobe the deeper groove with enucleation of one lateral lobe followed by the median and the remaining lateral lobe as a single unit
The three-lobe technique involves a 5- and 7- Oclock incisions with enucleation of the median lobe and subsequent enucleation of one lateral lobe followed by the other lateral lobe
If bleeding is encountered the laser fiber can be defocused slightly from the bleeding point to achieve hemostasis
Furosemide 20 mghour intravenously is administered after one hour of surgery to correct for any fluid absorption and to enhance urine flow After hemostasis the morcellator is introduced and the prostatic lobes are morcellated and removed
Follow-up
Patients will be seen in follow-up at 2-4 weeks 4 months and 12 months
Validated questionnaires will be utilized to assess the patients sexual function both at base line and at different follow-up visits Different aspects of the sexual function will be analyzed
In patients who may have no symptomatic improvement after the procedure or who may have subsequent deterioration cystoscopy will be performed to rule out the development of a urethral stricture or bladder neck contracture Treatment will be planned accordingly for the present finding
Outcome measures
Primary outcomes
The primary outcomes of this clinical trial will be operative outcome measures including
Operative time which is the time from insertion of the resectoscope till the time of catheterization operative efficacy which is the number or grams of the resected prostate tissue weight divided by operative time enucleation efficacy study endpoint which is the number of grams of the resected prostate tissue divided by enucleation time laser prostate ratio which is the amount of the joules of laser energy spent to remove one gram of the prostate tissue and the peri-procedure blood changes Hg deficit Hct deficit Na changes
Secondary outcomes
These parameters include time to catheter removal duration of hospital stay and complications intraoperative early postoperative during first 30 days after the procedure late postoperative
Furthermore urinary outcome measures IPSS international prostate symptoms score QOL quality of life Q-max peak flow rate PVR post voiding residual and sexual outcome measures Changes in the IIEF-15 international index of erectile function-15 will be depicted and compared
Tertiary outcome
The cumulative health resources related cost analysis of both procedures from a local institutional perspective actual cost Costs linked to the medical staff will not be included because they were assumed to be identical between the 2 groups similarly routine clinic visits will not be included
Participants flow diagram CONSORT CHART
For each group the numbers of participants who will be randomly assigned receive intended treatment and will be analyzed for the primary outcome Losses and exclusions will be described in each group
Sample size and statistical analysis
In this study the investigators will test the non-inferiority of LP-HoLEP to HP-HoLEP in accomplishing the transurethral enucleation procedure with comparable enucleation efficacy pertaining the advantages of lower cost and potential minimal postoperative dysuria
Type 1 statistical error less than 5 and type 2 statistical error less than 20 were considered Furthermore based on previous report enucleation efficacy using LP-HoLEP was reported as 068 04 95CI 061-075 gmmin 7 with an acceptable non-inferiority margin of 02gmmin was considered
Considering the previous factors a sample size of 100 patients 50 in each group was estimated
Benign prostatic hyperplasia BPH is a pathologic process that contributes to but is not the sole cause of lower urinary tract symptoms LUTS in aging men
The decision to intervene is frequently used as an end point after failure of different medical therapies These medications are able to delay this point Failed medical treatment either due to refractory LUTS or in patients who are not willing to make a lifetime commitment to medical therapy represents one indication to intervene
Urine retention secondary to BPH with failed voiding trial without catheter is an indication for intervention in healthy individuals as well as recurrent hematuria secondary vesical stones and recurrent urinary tract infection Renal deterioration secondary to BPH is an indication of intervention after proper evaluation of the bladder function
For years surgical treatment for BPH was transurethral resection of the prostate TURP for small to moderate sized prostate and open prostatectomy OP for markedly enlarged one
Laser prostatectomy was introduced as a less invasive modality for treatment of BPH overcoming the disadvantages and limitations of the traditional standard TURP and OP It seems to be advantageous as it is less invasive than OP Furthermore using physiological saline as an irrigant with higher safety profile in morbid patients who have to be on anticoagulants or antiplatelet during surgery It is used to tackle larger prostate glands beyond the limits of TURP It is not infrequent to be done as day surgery with shortened catheterization time
Eventually it seems to be cost effective however the remaining concern as in all minimally invasive surgeries MIS is the durability and reoperation rates Despite the significant advantages known with laser prostatectomy techniques particularly HoLEP adoption of these procedures in urologic community is limited and one of the causes is the high initial cost investment for laser capital equipment
HoLEP entails dissection of the whole median and lateral prostatic lobes off the surgical capsule via a retrograde approach starting at the apex The enucleated lobes were pushed to the bladder followed by hemostasis of the prostate bed then intravesical morcellation of the enucleated adenoma
Over the past 15 years different technical modifications have come out to the procedure However all the current reports use 100 watt laser power High power HoLEP HP-HoLEP for the laser assisted enucleation technique
Khan et al 2015 reported on the feasibility of using low power LP-HoLEP for safe and effective HoLEP The authors cut significantly on the initial cost of laser capital equipment They used 50-watt holmium laser machine to accomplish the enucleation procedure with reasonable efficacy Nevertheless there are no randomized studies assessing safety efficacy and cost saving associated with LP-HoLEP
Aim of the Work
This study aims to compare safety and efficacy of LP-HoLEP vs HP-HoLEP in treatment of infra-vesical obstruction secondary to BPH
Patients and Methods
Study design Randomized Controlled Trial RCT
Study population
BPH surgical candidates presented to the outpatient clinic of the prostate unit in the urology department Urology nephrology center Mansoura University will be assessed to evaluate if these patients are eligible to the study inclusion criteria
BPH surgical candidates are patients presented with LUTS secondary to BOO bladder outlet obstruction due to BPH who failed medical treatment IPSS international prostate symptom score score 15 peak urinary flow rate Qmax 15 mlsec recurrent attacks of urine retention with failed trial voiding patients with hematuria of prostatic origin with failed medical treatment and patients with vesical stone secondary to BPH
Preoperative work up
All patients will be thoroughly evaluated by medical history and physical exam digital rectal exam DRE prostate specific antigen PSA urinalysis and urine culture international index of prostate symptom score IPSS transrectal ultrasound TRUS measurement of prostatic volume and biopsy whenever indicated measurement of post-void residual assessment PVR and maximum urinary flow rate Qmax Patients with positive urine culture will be treated accordingly
Randomization
Patients will be randomly assigned to the study groups on the day of the surgery after signing the informed consent for participation in the study The randomization process will be performed using computer-generated random tables in a 11 ratio A stratified-blocked randomization across two strata derived from predetermined size grouping 40-80 ml and more than 80 ml and two strata derived from preoperative indication catheterized and non-catheterized were done This method ensures parity among the two treatment groups In each stratum given two possible block lengths of four and eight respectively with a random number generator giving numbers uniformly distributed between 0 and 1 the investigators selected a block length of four for random numbers lower than 05 or a block length of eight otherwise Variation of the block sizes prevented the surgeon from guessing what the next treatment will be it makes it difficult although not impossible to break the treatment code
Eligible patients will be randomized into one of two groups
Group 1 50 patients Patients will be managed with HP-HoLEP Group 2 50 patients Patients will be managed with LP-HoLEP
Procedure
In case of coexisting urinary bladder stone Holmium laser cystolithotripsy will be done first
Laser setting
HP-HoLEP Energy2 Joule Rate50 Hertz for adenoma enucleation reduced to Energy15 Rate30 for apical dissection hemostasis
LP-HoLEP Energy2 Joule Rate25 throughout the whole procedure
Surgical Technique
HoLEP can be divided into four phases inspection enucleation hemostasis and morcellation Briefly a plane was created between the adenoma and the surgical capsule early after the first incision of the gland from the bladder neck to the level of the verumontanum The gland was enucleated in two or three lobes depending on the anatomy and the prominence of the grooves on either side of the middle lobe
The Two-lobe technique starts with a 5- or 7-Oclock incision in a groove between the median lobe and one lateral lobe the deeper groove with enucleation of one lateral lobe followed by the median and the remaining lateral lobe as a single unit
The three-lobe technique involves a 5- and 7- Oclock incisions with enucleation of the median lobe and subsequent enucleation of one lateral lobe followed by the other lateral lobe
If bleeding is encountered the laser fiber can be defocused slightly from the bleeding point to achieve hemostasis
Furosemide 20 mghour intravenously is administered after one hour of surgery to correct for any fluid absorption and to enhance urine flow After hemostasis the morcellator is introduced and the prostatic lobes are morcellated and removed
Follow-up
Patients will be seen in follow-up at 2-4 weeks 4 months and 12 months
Validated questionnaires will be utilized to assess the patients sexual function both at base line and at different follow-up visits Different aspects of the sexual function will be analyzed
In patients who may have no symptomatic improvement after the procedure or who may have subsequent deterioration cystoscopy will be performed to rule out the development of a urethral stricture or bladder neck contracture Treatment will be planned accordingly for the present finding
Outcome measures
Primary outcomes
The primary outcomes of this clinical trial will be operative outcome measures including
Operative time which is the time from insertion of the resectoscope till the time of catheterization operative efficacy which is the number or grams of the resected prostate tissue weight divided by operative time enucleation efficacy study endpoint which is the number of grams of the resected prostate tissue divided by enucleation time laser prostate ratio which is the amount of the joules of laser energy spent to remove one gram of the prostate tissue and the peri-procedure blood changes Hg deficit Hct deficit Na changes
Secondary outcomes
These parameters include time to catheter removal duration of hospital stay and complications intraoperative early postoperative during first 30 days after the procedure late postoperative
Furthermore urinary outcome measures IPSS international prostate symptoms score QOL quality of life Q-max peak flow rate PVR post voiding residual and sexual outcome measures Changes in the IIEF-15 international index of erectile function-15 will be depicted and compared
Tertiary outcome
The cumulative health resources related cost analysis of both procedures from a local institutional perspective actual cost Costs linked to the medical staff will not be included because they were assumed to be identical between the 2 groups similarly routine clinic visits will not be included
Participants flow diagram CONSORT CHART
For each group the numbers of participants who will be randomly assigned receive intended treatment and will be analyzed for the primary outcome Losses and exclusions will be described in each group
Sample size and statistical analysis
In this study the investigators will test the non-inferiority of LP-HoLEP to HP-HoLEP in accomplishing the transurethral enucleation procedure with comparable enucleation efficacy pertaining the advantages of lower cost and potential minimal postoperative dysuria
Type 1 statistical error less than 5 and type 2 statistical error less than 20 were considered Furthermore based on previous report enucleation efficacy using LP-HoLEP was reported as 068 04 95CI 061-075 gmmin 7 with an acceptable non-inferiority margin of 02gmmin was considered
Considering the previous factors a sample size of 100 patients 50 in each group was estimated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None