Prostatic HyperplasiaNCT06209307
Pelvic Floor Physical Therapy to Reduce Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
A study testing Pelvic floor physical therapy in people with Prostatic Hyperplasia and Stress Urinary Incontinence, run by University of California, Irvine at 1 site in United States.
Trial summary
Holmium laser enucleation of the prostate (HoLEP) is a surgical procedure used to treat benign prostatic hyperplasia (BPH). HoLEP involves the removal of obstructive prostatic tissue via an endoscopic approach to relieve bothersome urinary symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia, Stress Urinary Incontinence
- What is being tested?
- Pelvic floor physical therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adult males who have lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) and considering/undergoing HoLEP for LUTS/BPH treatment at the University of California Irvine Medical Center.
- Age >= 18
- English-speaker
Who cannot join
- Non-English speaker
- Having an indwelling catheter preoperatively
- Neurological disorders that might potentially affect muscle function
- Neurogenic bladder
- Lumbosacral spine pathology
- Any condition that can interfere with pelvic muscle function per principal investigator's discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Irvine Medical Center
Orange, California, 92868
About this study
Official title: Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Holmium laser enucleation of the prostate (HoLEP) is a surgical procedure used to treat benign prostatic hyperplasia (BPH). HoLEP involves the removal of obstructive prostatic tissue via an endoscopic approach to relieve bothersome urinary symptoms. HoLEP is recommended by the American Urological Association (AUA) as a size-independent treatment for BPH. While the surgery is highly durable and versatile, post-operative stress urinary incontinence (SUI) has been reported following HoLEP, up to 44%. Pelvic floor physical therapy (PFPT) is a therapeutic strategy with low cost and risk to patients used to treat SUI following prostate surgery. However, data on the efficacy of conducting PFPT prior to HoLEP in minimizing or eliminating post-operative urinary incontinence is limited. The investigators will recruit patients who have already agreed to undergo HoLEP for this study. Participants will be randomized into two groups: The intervention group will begin standardized PFPT before surgery and will continue PFPT after surgery, and the second group will begin PFPT after surgery only (current practice). Both groups will continue with PFPT following surgery until urinary continence is regained. Investigators will compare the time required to regain urinary continence and patient-reported outcomes between the two groups.
Read the detailed description
The incidence of benign prostatic hyperplasia (BPH) in men significantly increases with age and is estimated to impact over 80% of men 70 to 80 years of age. HoLEP is one of many treatments for BPH and associated lower urinary tract symptoms (LUTS). Compared to other minimally invasive surgical techniques for the treatment of BPH, HoLEP has been found to have superior outcomes and is a prostate size-independent procedure with excellent durability, high efficacy, and low complication rates. However, transient stress urinary incontinence (SUI) following HoLEP may last for several months after surgery and can lead to diminished patient quality of life (QoL) during the recovery period. Measures to prevent or reduce post-operative SUI following HoLEP, including PFPT, may improve patient outcomes.
SUI is also commonly documented after radical prostatectomy (RP) for prostate cancer. The mechanism for incontinence in both RP and HoLEP is thought to at least partially be related to temporary weakness of the external urinary sphincter, which is part of the pelvic floor musculature. While it is unclear if post-operative PFPT alone reduces SUI for patients who have undergone RP, there is evidence that PFPT started pre-operatively and continued post-operatively can decrease SUI following RP.
The utilization of pre-operative PFPT for patients undergoing HoLEP to reduce post-operative SUI is currently not well documented. To date, only one study has demonstrated evidence that PFPT prior to HoLEP may improve continence at 3 months. However, the study included patients with a BMI significantly lower than average in the United States, utilized an unclear PFPT program, and had a relatively small median prostate size (~60 mL), which is important as studies have shown that prostate size can affect post-operative incontinence.
Investigators propose a prospective randomized trial to investigate the efficacy of standardized pre-operative PFPT in reducing SUI and improving patient QoL following HoLEP. This study will help determine the role of pre-operative PFPT in the management of HoLEP-associated SUI.
- Conditions
- Prostatic Hyperplasia, Stress Urinary Incontinence
- Being tested
- Pelvic floor physical therapy
- Medical subject headings
- Prostatic Hyperplasia, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor physical therapyBehavioural
Pelvic floor physical therapy (i.e., Kegel exercises):
- Finding the right muscles: To identify pelvic floor muscles, the patient should stop urination in midstream or tighten the muscles that keep from passing gas. These maneuvers use pelvic floor muscles. Once the pelvic floor muscles are identified, the patient can do the exercises in any position, although doing them lying down at first might be the easiest approach.
- Perfecting the technique: Tighten pelvic floor muscles, hold the contraction for three seconds, and then relax for three seconds. Try it a few times in a row. When muscles get stronger, try doing Kegel exercises while sitting, standing, or walking.
- Maintaining focus: For best results, focus on tightening only pelvic floor muscles. Be careful not to flex the muscles in the abdomen, thighs, or buttocks. Avoid breath-holding. Instead, breathe freely during the exercises.
- Repeat 3 times a day. Aim for three sets of 10 repetitions a day.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Preoperative and postoperative pelvic floor physical therapy | Experimental | Pelvic floor physical therapy (PFPT) will be initiated 1 month before surgery in patients randomized to Arm 1. Receives: Behavioral: Pelvic floor physical therapy |
| Arm 2: Postoperative pelvic floor physical therapy only. | No intervention | At 1-3 days follow-up after surgery pelvic floor physical therapy (PFPT) will be initiated in the post-operative PFPT-only group as part of standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to urinary continence following catheter removal after HoLEP
Time to recover from transient postoperative stress urinary incontinence
Measured: 6 months after surgery
Secondary outcomes (8)
Uroflow
Urine flow rate (milliliters/second)
Measured: 6 months after surgery
Post void residual
Residual urine after voiding (milliliters)
Measured: 6 months after surgery
American Urological Association Symptom Score
Validated questionnaire on urination symptoms
Measured: 6 months after surgery
Operative time
Length of surgery (minutes)
Measured: Day of surgery
Length of hospital stay
Days of hospitalization after surgery
Measured: 30 days after surgery
Catheter duration
Days with catheter after surgery
Measured: 30 days after surgery
Infectious complications
Urinary tract infection complication after surgery
Measured: 30 days after surgery
Emergency room visits
Number of emergency room visits related to surgery
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start8 Feb 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akhil Das, University of California, Irvine
- Investigators
- Akhil Das, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209307
- Sponsor's protocol ID
- 3574
- Status last verified
- Nov 2025
- First submitted
- 22 Dec 2023
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.
PubMed 1279218Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686Montorsi F, Naspro R, Salonia A, Suardi N, Briganti A, Zanoni M, Valenti S, Vavassori I, Rigatti P. Holmium laser enucleation versus transurethral resection of the prostate: results from a 2-center prospective randomized trial in patients with obstructive benign prostatic hyperplasia. J Urol. 2008 May;179(5 Suppl):S87-90. doi: 10.1016/j.juro.2008.03.143.
PubMed 18405765Roehrborn CG. Benign prostatic hyperplasia: an overview. Rev Urol. 2005;7 Suppl 9(Suppl 9):S3-S14.
PubMed 16985902Michalak J, Tzou D, Funk J. HoLEP: the gold standard for the surgical management of BPH in the 21(st) Century. Am J Clin Exp Urol. 2015 Apr 25;3(1):36-42. eCollection 2015.
PubMed 26069886Das AK, Teplitsky S, Chandrasekar T, Perez T, Guo J, Leong JY, Shenot PJ. Stress Urinary Incontinence post-Holmium Laser Enucleation of the Prostate: a Single-Surgeon Experience. Int Braz J Urol. 2020 Jul-Aug;46(4):624-631. doi: 10.1590/S1677-5538.IBJU.2019.0411.
PubMed 32374125Han E, Black LK, Lavelle JP. Incontinence related to management of benign prostatic hypertrophy. Am J Geriatr Pharmacother. 2007 Dec;5(4):324-34. doi: 10.1016/j.amjopharm.2007.12.003.
PubMed 18179990Hout M, Gurayah A, Arbelaez MCS, Blachman-Braun R, Shah K, Herrmann TRW, Shah HN. Incidence and risk factors for postoperative urinary incontinence after various prostate enucleation procedures: systemic review and meta-analysis of PubMed literature from 2000 to 2021. World J Urol. 2022 Nov;40(11):2731-2745. doi: 10.1007/s00345-022-04174-1. Epub 2022 Oct 4.
PubMed 36194286Centemero A, Rigatti L, Giraudo D, Lazzeri M, Lughezzani G, Zugna D, Montorsi F, Rigatti P, Guazzoni G. Preoperative pelvic floor muscle exercise for early continence after radical prostatectomy: a randomised controlled study. Eur Urol. 2010 Jun;57(6):1039-43. doi: 10.1016/j.eururo.2010.02.028. Epub 2010 Mar 1.
PubMed 20227168Anan G, Kaiho Y, Iwamura H, Ito J, Kohada Y, Mikami J, Sato M. Preoperative pelvic floor muscle exercise for early continence after holmium laser enucleation of the prostate: a randomized controlled study. BMC Urol. 2020 Jan 23;20(1):3. doi: 10.1186/s12894-019-0570-5.
PubMed 31973706Moore KN, Cody DJ, Glazener CM. Conservative management for post prostatectomy urinary incontinence. Cochrane Database Syst Rev. 2001;(2):CD001843. doi: 10.1002/14651858.CD001843.
PubMed 11406013
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
- ClinicalTrials.gov ID
- NCT06209307
- Acronym / sponsor ID
- 3574
- Conditions
- Prostatic Hyperplasia, Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 17 Jan 2024 (actual)
- 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.
Holmium laser enucleation of the prostate (HoLEP) is a surgical procedure used to treat benign prostatic hyperplasia (BPH). HoLEP involves the removal of obstructive prostatic tissue via an endoscopic approach to relieve bothersome urinary symptoms. HoLEP is recommended by the American Urological Association (AUA) as a size-independent treatment for BPH. While the surgery is highly durable and versatile, post-operative stress urinary incontinence (SUI) has been reported following HoLEP, up to 44%. Pelvic floor physical therapy (PFPT) is a therapeutic strategy with low cost and risk to patients used to treat SUI following prostate surgery. However, data on the efficacy of conducting PFPT prior to HoLEP in minimizing or eliminating post-operative urinary incontinence is limited. The investigators will recruit patients who have already agreed to undergo HoLEP for this study. Participants will be randomized into two groups: The intervention group will begin standardized PFPT before surgery and will continue PFPT after surgery, and the second group will begin PFPT after surgery only (current practice). Both groups will continue with PFPT following surgery until urinary continence is regained. Investigators will compare the time required to regain urinary continence and patient-reported outcomes between the two groups.
Detailed description
The incidence of benign prostatic hyperplasia (BPH) in men significantly increases with age and is estimated to impact over 80% of men 70 to 80 years of age. HoLEP is one of many treatments for BPH and associated lower urinary tract symptoms (LUTS). Compared to other minimally invasive surgical techniques for the treatment of BPH, HoLEP has been found to have superior outcomes and is a prostate size-independent procedure with excellent durability, high efficacy, and low complication rates. However, transient stress urinary incontinence (SUI) following HoLEP may last for several months after surgery and can lead to diminished patient quality of life (QoL) during the recovery period. Measures to prevent or reduce post-operative SUI following HoLEP, including PFPT, may improve patient outcomes.
SUI is also commonly documented after radical prostatectomy (RP) for prostate cancer. The mechanism for incontinence in both RP and HoLEP is thought to at least partially be related to temporary weakness of the external urinary sphincter, which is part of the pelvic floor musculature. While it is unclear if post-operative PFPT alone reduces SUI for patients who have undergone RP, there is evidence that PFPT started pre-operatively and continued post-operatively can decrease SUI following RP.
The utilization of pre-operative PFPT for patients undergoing HoLEP to reduce post-operative SUI is currently not well documented. To date, only one study has demonstrated evidence that PFPT prior to HoLEP may improve continence at 3 months. However, the study included patients with a BMI significantly lower than average in the United States, utilized an unclear PFPT program, and had a relatively small median prostate size (~60 mL), which is important as studies have shown that prostate size can affect post-operative incontinence.
Investigators propose a prospective randomized trial to investigate the efficacy of standardized pre-operative PFPT in reducing SUI and improving patient QoL following HoLEP. This study will help determine the role of pre-operative PFPT in the management of HoLEP-associated SUI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Preoperative and postoperative pelvic floor physical therapy | Experimental | Behavioral: Pelvic floor physical therapyPelvic floor physical therapy (PFPT) will be initiated 1 month before surgery in patients randomized to Arm 1. |
| Arm 2: Postoperative pelvic floor physical therapy only. | No intervention | –At 1-3 days follow-up after surgery pelvic floor physical therapy (PFPT) will be initiated in the post-operative PFPT-only group as part of standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult males who have lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) and considering/undergoing HoLEP for LUTS/BPH treatment at the University of California Irvine Medical Center.
- Age >= 18
- English-speaker
Key exclusion criteria (6 listed)
- Non-English speaker
- Having an indwelling catheter preoperatively
- Neurological disorders that might potentially affect muscle function
- Neurogenic bladder
- Lumbosacral spine pathology
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 |
|---|---|---|
| Pelvic floor physical therapyPelvic floor physical therapy (i.e., Kegel exercises): * Finding the right muscles: To identify pelvic floor muscles, the patient should stop urination in midstream or tighten the muscles that keep from passing gas. These maneuvers use pelvic floor muscles. Once the pelvic floor muscles are identified, the patient can do the exercises in any position, although doing them lying down at first might be the easiest approach. * Perfecting the technique: Tighten pelvic floor muscles, hold the contraction for three seconds, and then relax for three seconds. Try it a few times in a row. When muscles get stronger, try doing Kegel exercises while sitting, standing, or walking. * Maintaining focus: For best results, focus on tightening only pelvic floor muscles. Be careful not to flex the muscles in the abdomen, thighs, or buttocks. Avoid breath-holding. Instead, breathe freely during the exercises. * Repeat 3 times a day. Aim for three sets of 10 repetitions a day. | Behavioural | Arm 1: Preoperative and postoperative pelvic floor physical therapy |
Primary outcome
Time to urinary continence following catheter removal after HoLEP
Time frame: 6 months after surgery
Time to recover from transient postoperative stress urinary incontinence
8 secondary outcomes
Uroflow
Time frame: 6 months after surgery
Post void residual
Time frame: 6 months after surgery
American Urological Association Symptom Score
Time frame: 6 months after surgery
Operative time
Time frame: Day of surgery
Length of hospital stay
Time frame: 30 days after surgery
Catheter duration
Time frame: 30 days after surgery
Infectious complications
Time frame: 30 days after surgery
Emergency room visits
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 1279218Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.
- Background: PubMed 18929686Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
- Background: PubMed 18405765Montorsi F, Naspro R, Salonia A, Suardi N, Briganti A, Zanoni M, Valenti S, Vavassori I, Rigatti P. Holmium laser enucleation versus transurethral resection of the prostate: results from a 2-center prospective randomized trial in patients with obstructive benign prostatic hyperplasia. J Urol. 2008 May;179(5 Suppl):S87-90. doi: 10.1016/j.juro.2008.03.143.
- Background: PubMed 16985902Roehrborn CG. Benign prostatic hyperplasia: an overview. Rev Urol. 2005;7 Suppl 9(Suppl 9):S3-S14.
- Background: PubMed 26069886Michalak J, Tzou D, Funk J. HoLEP: the gold standard for the surgical management of BPH in the 21(st) Century. Am J Clin Exp Urol. 2015 Apr 25;3(1):36-42. eCollection 2015.
- Background: PubMed 32374125Das AK, Teplitsky S, Chandrasekar T, Perez T, Guo J, Leong JY, Shenot PJ. Stress Urinary Incontinence post-Holmium Laser Enucleation of the Prostate: a Single-Surgeon Experience. Int Braz J Urol. 2020 Jul-Aug;46(4):624-631. doi: 10.1590/S1677-5538.IBJU.2019.0411.
- Background: PubMed 18179990Han E, Black LK, Lavelle JP. Incontinence related to management of benign prostatic hypertrophy. Am J Geriatr Pharmacother. 2007 Dec;5(4):324-34. doi: 10.1016/j.amjopharm.2007.12.003.
- Background: PubMed 36194286Hout M, Gurayah A, Arbelaez MCS, Blachman-Braun R, Shah K, Herrmann TRW, Shah HN. Incidence and risk factors for postoperative urinary incontinence after various prostate enucleation procedures: systemic review and meta-analysis of PubMed literature from 2000 to 2021. World J Urol. 2022 Nov;40(11):2731-2745. doi: 10.1007/s00345-022-04174-1. Epub 2022 Oct 4.
- Background: PubMed 20227168Centemero A, Rigatti L, Giraudo D, Lazzeri M, Lughezzani G, Zugna D, Montorsi F, Rigatti P, Guazzoni G. Preoperative pelvic floor muscle exercise for early continence after radical prostatectomy: a randomised controlled study. Eur Urol. 2010 Jun;57(6):1039-43. doi: 10.1016/j.eururo.2010.02.028. Epub 2010 Mar 1.
- Background: PubMed 31973706Anan G, Kaiho Y, Iwamura H, Ito J, Kohada Y, Mikami J, Sato M. Preoperative pelvic floor muscle exercise for early continence after holmium laser enucleation of the prostate: a randomized controlled study. BMC Urol. 2020 Jan 23;20(1):3. doi: 10.1186/s12894-019-0570-5.
- Background: PubMed 11406013Moore KN, Cody DJ, Glazener CM. Conservative management for post prostatectomy urinary incontinence. Cochrane Database Syst Rev. 2001;(2):CD001843. doi: 10.1002/14651858.CD001843.
- Individual participant dataSharing planned: No
Related trials for Prostatic Hyperplasia
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
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.
Akhil Das, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor physical therapy in people with Prostatic Hyperplasia and Stress Urinary Incontinence, run by University of California, Irvine at 1 site 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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Time to urinary continence following catheter removal after HoLEP (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06209307, which also lists 11 linked publications.
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 3 Dec 2025.