Lower Urinary Tract SymptomsNCT01604148
Retrospective Review a Comprehensive Case Database of HoLEP Procedure Performed by a Single Surgeon
An observational study of Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Persistent detrusor overactivity (DO) after transurethral prostatectomy results in symptomatic failure in more than one third of the patients. Storage symptoms are major complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate (HoLEP). Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Jul 2011
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent Holmium Laser Enucleation of the Prostate by a single surgeon
Who may be able to join
- 50 yrs or greater
- International prostatic symptom score >= 12
- Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)
Who cannot join
- Patients with urologic malignancies such as prostate cancer and bladder cancer
- Patients underwent urethral, prostate surgery
- Patients with urethral stricture or bladder diverticulum or bladder neck contracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Review of a Comprehensive Case Database of HoLEP (Holmium Laser Enucleation of Prostate) Procedure Performed by a Single Surgeon
Persistent detrusor overactivity (DO) after transurethral prostatectomy results in symptomatic failure in more than one third of the patients. Storage symptoms are major complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate (HoLEP). To investigate the effect of DO in the patients with Benign Prostatic Obstruction (BPO), the investigators evaluated the changes in the storage symptoms following HoLEP in conjunction with the prescription of the anticholinergic drugs.
Read the detailed description
Eighty men with urodynamically proven BPO underwent HoLEP at our hospital. All patients were evaluated preoperatively with International Prostate Symptom Score (IPSS), International Continence Society male questionnaire short form (ICS-SF), 3-day frequency - volume charts (FVC), transrectal ultrasonography, and uroflowmetry with postvoid residual urine volume. The patients were divided into two groups; BPO without DO (Non-DO group) and BPO with DO (DO group). We assessed the patients postoperatively at 2 weeks, 1, 3 and 6 months after surgery.
- Keywords
- Holmium Laser Enucleation of Prostate
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HoLEP group | Holmium Laser Enucleation of Prostate Group |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startJul 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyu-Sung Lee, Ph.D, M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604148
- Sponsor's protocol ID
- 2011-06-082
- Status last verified
- May 2012
- First submitted
- 21 May 2012
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of a Comprehensive Case Database of HoLEP (Holmium Laser Enucleation of Prostate) Procedure Performed by a Single Surgeon
- ClinicalTrials.gov ID
- NCT01604148
- Acronym / sponsor ID
- 2011-06-082
- Keywords
- Holmium Laser Enucleation of Prostate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 May 2012 (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.
Persistent detrusor overactivity (DO) after transurethral prostatectomy results in symptomatic failure in more than one third of the patients. Storage symptoms are major complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate (HoLEP). To investigate the effect of DO in the patients with Benign Prostatic Obstruction (BPO), the investigators evaluated the changes in the storage symptoms following HoLEP in conjunction with the prescription of the anticholinergic drugs.
Detailed description
Eighty men with urodynamically proven BPO underwent HoLEP at our hospital. All patients were evaluated preoperatively with International Prostate Symptom Score (IPSS), International Continence Society male questionnaire short form (ICS-SF), 3-day frequency - volume charts (FVC), transrectal ultrasonography, and uroflowmetry with postvoid residual urine volume. The patients were divided into two groups; BPO without DO (Non-DO group) and BPO with DO (DO group). We assessed the patients postoperatively at 2 weeks, 1, 3 and 6 months after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HoLEP group | – | –Holmium Laser Enucleation of Prostate Group |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent Holmium Laser Enucleation of the Prostate by a single surgeon
Key inclusion criteria (3 listed)
- 50 yrs or greater
- International prostatic symptom score >= 12
- Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)
Key exclusion criteria (3 listed)
- Patients with urologic malignancies such as prostate cancer and bladder cancer
- Patients underwent urethral, prostate surgery
- Patients with urethral stricture or bladder diverticulum or bladder neck contracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
Related trials for Lower Urinary Tract Symptoms
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
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.
Kyu-Sung Lee, Ph.D, M.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by Samsung Medical Center at 1 site in South Korea.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 23 May 2012.