Benign Prostatic HyperplasiaNCT00169767
Holmium Laser Ablation of the Prostate (HoLAP) Versus KTP Laser Vaporization of the Prostate
An observational study of Benign Prostatic Hyperplasia, run by Indiana Kidney Stone Institute at 3 sites in United States.
Trial summary
Many options currently exist to relieve the symptoms caused by benign prostatic hyperplasia (BPH). At present, transurethral resection of the prostate (TURP) serves as the surgical standard to which all other operative treatments are compared. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Comparison study between KTP and HoLAP for BPH
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2005to Apr 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: urology clinic
Who may be able to join
- Ability to give informed consent
- Lower urinary tract symptoms (LUTS) felt to be secondary to bladder outlet obstruction from benign prostatic hyperplasia
- Maximum urinary flow rate < 15 ml/sec, voided volume ≥ 125 cc
- American Urological Association symptom score ≥ 9
- Transrectal ultrasound determined prostate volume ≤ 60 cc
Who cannot join
- Inability to give informed consent
- Maximum urinary flow rate ≥ 15 ml/sec
- Transrectal ultrasound determined prostate volume > 60cc
- AUA symptom score < 9
- Active urinary tract infection
- Bleeding diathesis
Show all 12Show fewer
- Neurological disease that is felt to affect the bladder or a history of a neurogenic or chronically decompensated bladder
- Known prostate cancer
- Active bladder cancer (within the last 2 years)
- Prostate specific antigen (PSA) > 4.0 unless previous negative biopsy
- Urinary retention
- Post-void residual (PVR) > 300 cc
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke University
Durham, North Carolina, 27710
Methodist Hospital
Indianapolis, Indiana, 46202
Oakwood Annapolis Hospital
Westland, Michigan, 48186
About this study
Official title: Holmium Laser Ablation of the Prostate (HoLAP) Versus KTP Laser Vaporization of the Prostate: A Randomized Comparison Study
Many options currently exist to relieve the symptoms caused by benign prostatic hyperplasia (BPH). At present, transurethral resection of the prostate (TURP) serves as the surgical standard to which all other operative treatments are compared. Although TURP provides excellent short and long-term results, this procedure has many potential risks and complications. The desire to avoid the potential risks of TURP and still achieve results of comparable durability has led to the development of alternative surgical procedures.
One such surgical alternative in the treatment of BPH is holmium laser ablation of the prostate (HoLAP). HoLAP has been compared to TURP in a randomized clinical trial with comparable outcomes in both uroflow rate and symptom score improvements (Mottet, et al 1999). Use of the holmium laser in treating BPH provides specific advantages over TURP. The risk of dilutional hyponatremia is eliminated, as the holmium laser can be used in conjunction with a normal saline irrigant. In addition, the hemostatic properties of the holmium laser results in superior hemostasis, thus minimizing the risk of bleeding. HoLAP has been utilized for prostate glands up to 60 grams in volume, as larger glands become more inefficient to treat using a tissue vaporization technique.
Recently, another laser technology has been introduced for the surgical treatment of BPH, the potassium titanyl-phosphate (KTP) laser. This modality can also be used to vaporize obstructive prostate tissue, and has been studied through single arm clinical studies. Short-term results are promising, with significant improvements in voiding symptoms and urine flow rates as well as minimal associated morbidity. However, to date a randomized comparison study between HoLAP and KTP laser vaporization of the prostate has not been reported. A group of investigators with extensive experience with both procedures intends to objectively compare these two procedures in a randomized clinical trial.
Read the detailed description
The traditional surgical therapy for BPH is a transurethral resection of the prostate (McConnell et al, 1994). This surgery involves the insertion of a telescope (resectoscope) transurethrally into the prostate and bladder. An electrocautery loop attached to the resectoscope is then used to core out the inside of the prostate until the surgical capsule of the prostate is reached. A large catheter is left in the bladder for at least 1 day and saline irrigation of the bladder is often required for post-operative bleeding. Once the urine is clear, the catheter is removed and the patient undergoes a voiding trial. If voiding is successful, the patient is discharged home.
TURP produces excellent short and long-term results and remains a standard of care for the surgical treatment of BPH. Unfortunately, this durable procedure has many potential risks and complications including bleeding requiring blood transfusion (~5%), intraoperative complications (e.g. prostate capsule perforation), urethral and bladder injury, dilutional hyponatremia and the TUR syndrome, urinary tract infection (~5-10%), incontinence (~1%), erectile dysfunction (~5%), bladder neck contracture or urethral stricture (~5%), and delayed bleeding resulting in clot retention or secondary procedures to control bleeding. (American Urological Association [AUA] Guideline on Management of Benign Hyperplasia (2003). Chapter 1: Diagnosis and Treatment Recommendations Journal of Urology, 170: 530, 2003.)
One alternative to TURP that has been shown in a randomized clinical trial to reproduce the excellent results of TURP has been holmium laser ablation of the prostate (HoLAP) (Mottet et al, 1999). HoLAP is a simple procedure to perform in smaller prostate glands (ideally < 60 gm) and recently reported results suggest that this procedure produces good results that are durable up to 7 years (Gilling et al, 2002).
A new technology for use during prostate ablation is the high power potassium titanyl-phosphate (KTP) laser (Malek et al, 2000). This surgical procedure involves the use of the Laserscope™ KTP laser (San Jose, CA) to vaporize obstructing prostatic tissue in a technique similar to HoLAP. Most investigators have reported no significant complications with this new technology and in most cases, significant improvements in American Urological Association symptom scores and urine flow rates have been documented (Malek et al, 2000). Unfortunately, no randomized comparison study between HoLAP and KTP laser prostatectomy has been performed.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Comparison study between KTP and HoLAP for BPH
- Keywords
- Enlarged Prostate, BPH
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison study between KTP and HoLAP for BPHOther
Also called BPH
Comparison study between KTP and HoLAp for BPH
| Study group | Role | What they receive |
|---|---|---|
| A | Comparison study between KTP and HoLAP procedures for BPH Receives: Other: Comparison study between KTP and HoLAP for BPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative parameters, short and long-term results, and complications associated with HoLAP and KTP laser vaporization of the prostate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana Kidney Stone Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Lumenis Be Ltd.
- Investigators
- James E Lingeman, MD, Principal investigator, Methodist Urology, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169767
- Sponsor's protocol ID
- 05-042
- Status last verified
- Apr 2008
- First submitted
- 9 Sep 2005
- Last updated
- 25 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holmium Laser Ablation of the Prostate (HoLAP) Versus KTP Laser Vaporization of the Prostate: A Randomized Comparison Study
- ClinicalTrials.gov ID
- NCT00169767
- Acronym / sponsor ID
- 05-042
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Enlarged Prostate, BPH
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Indiana Kidney Stone InstituteUniversity, hospital or other
- Collaborators
- Lumenis Be Ltd.
- Study start
- May 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many options currently exist to relieve the symptoms caused by benign prostatic hyperplasia (BPH). At present, transurethral resection of the prostate (TURP) serves as the surgical standard to which all other operative treatments are compared. Although TURP provides excellent short and long-term results, this procedure has many potential risks and complications. The desire to avoid the potential risks of TURP and still achieve results of comparable durability has led to the development of alternative surgical procedures.
One such surgical alternative in the treatment of BPH is holmium laser ablation of the prostate (HoLAP). HoLAP has been compared to TURP in a randomized clinical trial with comparable outcomes in both uroflow rate and symptom score improvements (Mottet, et al 1999). Use of the holmium laser in treating BPH provides specific advantages over TURP. The risk of dilutional hyponatremia is eliminated, as the holmium laser can be used in conjunction with a normal saline irrigant. In addition, the hemostatic properties of the holmium laser results in superior hemostasis, thus minimizing the risk of bleeding. HoLAP has been utilized for prostate glands up to 60 grams in volume, as larger glands become more inefficient to treat using a tissue vaporization technique.
Recently, another laser technology has been introduced for the surgical treatment of BPH, the potassium titanyl-phosphate (KTP) laser. This modality can also be used to vaporize obstructive prostate tissue, and has been studied through single arm clinical studies. Short-term results are promising, with significant improvements in voiding symptoms and urine flow rates as well as minimal associated morbidity. However, to date a randomized comparison study between HoLAP and KTP laser vaporization of the prostate has not been reported. A group of investigators with extensive experience with both procedures intends to objectively compare these two procedures in a randomized clinical trial.
Detailed description
The traditional surgical therapy for BPH is a transurethral resection of the prostate (McConnell et al, 1994). This surgery involves the insertion of a telescope (resectoscope) transurethrally into the prostate and bladder. An electrocautery loop attached to the resectoscope is then used to core out the inside of the prostate until the surgical capsule of the prostate is reached. A large catheter is left in the bladder for at least 1 day and saline irrigation of the bladder is often required for post-operative bleeding. Once the urine is clear, the catheter is removed and the patient undergoes a voiding trial. If voiding is successful, the patient is discharged home.
TURP produces excellent short and long-term results and remains a standard of care for the surgical treatment of BPH. Unfortunately, this durable procedure has many potential risks and complications including bleeding requiring blood transfusion (~5%), intraoperative complications (e.g. prostate capsule perforation), urethral and bladder injury, dilutional hyponatremia and the TUR syndrome, urinary tract infection (~5-10%), incontinence (~1%), erectile dysfunction (~5%), bladder neck contracture or urethral stricture (~5%), and delayed bleeding resulting in clot retention or secondary procedures to control bleeding. (American Urological Association [AUA] Guideline on Management of Benign Hyperplasia (2003). Chapter 1: Diagnosis and Treatment Recommendations Journal of Urology, 170: 530, 2003.)
One alternative to TURP that has been shown in a randomized clinical trial to reproduce the excellent results of TURP has been holmium laser ablation of the prostate (HoLAP) (Mottet et al, 1999). HoLAP is a simple procedure to perform in smaller prostate glands (ideally < 60 gm) and recently reported results suggest that this procedure produces good results that are durable up to 7 years (Gilling et al, 2002).
A new technology for use during prostate ablation is the high power potassium titanyl-phosphate (KTP) laser (Malek et al, 2000). This surgical procedure involves the use of the Laserscope™ KTP laser (San Jose, CA) to vaporize obstructing prostatic tissue in a technique similar to HoLAP. Most investigators have reported no significant complications with this new technology and in most cases, significant improvements in American Urological Association symptom scores and urine flow rates have been documented (Malek et al, 2000). Unfortunately, no randomized comparison study between HoLAP and KTP laser prostatectomy has been performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: Comparison study between KTP and HoLAP for BPHComparison study between KTP and HoLAP procedures for BPH |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- urology clinic
Key inclusion criteria (5 listed)
- Ability to give informed consent
- Lower urinary tract symptoms (LUTS) felt to be secondary to bladder outlet obstruction from benign prostatic hyperplasia
- Maximum urinary flow rate < 15 ml/sec, voided volume ≥ 125 cc
- American Urological Association symptom score ≥ 9
- Transrectal ultrasound determined prostate volume ≤ 60 cc
Key exclusion criteria (12 listed)
- Inability to give informed consent
- Maximum urinary flow rate ≥ 15 ml/sec
- Transrectal ultrasound determined prostate volume > 60cc
- AUA symptom score < 9
- Active urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison study between KTP and HoLAP for BPHAlso: BPHComparison study between KTP and HoLAp for BPH | Other | A |
Primary outcome
operative parameters, short and long-term results, and complications associated with HoLAP and KTP laser vaporization of the prostate
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James E Lingeman, MD principal investigator
Methodist Urology, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, run by Indiana Kidney Stone Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operative parameters, short and long-term results, and complications associated with HoLAP and KTP laser vaporization of the prostate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2008.