Benign Prostatic HyperplasiaNCT04912349
Comparison of TUSP Versus TURP for Treatment of Benign Prostatic Hyperplasia in a Small Prostate Volume
A study testing TUSP and TURP in people with Benign Prostatic Hyperplasia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Comparison of transurethral split of the prostate versus transurethral resection of the prostate for treatment of benign prostatic hyperplasia in a small prostate volume: A prospective controlled study Read more about this study
- Who is it for?
- Ages 35 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- TUSP and TURP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 30 Jun 2022
- Phase
- Interventional
- 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 35 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Benign prostatic hyperplasia patients with surgical indication
- Maximum flow rate <12ml/s
- Prostate volume <30ml
- The international prostate symptoms score>21
- Medication of α-adrenergic blockers for at least 3 months
Who cannot join
- Acute prostatitis and urethritis
- Neurogenic bladder
- Abnormal prostate-specific antigen level
- Urethral injury history
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Jiaming Wen, Dr., +86-571-87783550, wenjiaming@zju.edu.cn
About this study
Official title: Comparison of Transurethral Split of the Prostate Versus Transurethral Resection of the Prostate for Treatment of Benign Prostatic Hyperplasia in a Small Prostate Volume: A Prospective Controlled Study
Comparison of transurethral split of the prostate versus transurethral resection of the prostate for treatment of benign prostatic hyperplasia in a small prostate volume: A prospective controlled study
Read the detailed description
Transurethral resection of the prostate (TURP) was considered as the golden standard to treat benign prostatic hyperplasia (BPH) for decades. However, TURP was associated with low efficiency to alleviate the lower urinary tract symptoms and a significantly higher risk of bladder neck contracture (BNC) for patients with small-volume BPH. We aimed to compare the therapeutic effect of transurethral split of the prostate (TUSP) with TURP for patients with small-volume BPH (<30 ml).
In this study, some selected small-volume BPH patients were randomly divided into two groups (TUSP and TURP group). The patient's baseline characteristics and perioperative outcomes were recorded. The follow-up was made at 6 months, 1 year and 2 years after surgical treatment.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- TUSP, TURP
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUSPProcedure or surgery
Patients received the transurethral split of the prostate(TUSP) treatment.
TURPProcedure or surgery
Patients received the transurethral resection of the prostate(TURP) treatment.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Patients received the transurethral split of the prostate(TUSP) treatment. Receives: Procedure: TUSP |
| Control Group | Active comparator | Patients received the transurethral resection of the prostate(TURP) treatment. Receives: Procedure: TURP |
What is being measured
The primary outcome is the main question the study is designed to answer.
international prostate symptoms score（IPSS）
Measuring the International Prostate Symptoms Score by a questionnaire (which minimum value is zero and the maximum value is 35; higher scores mean a worse outcome)
Measured: within 24 months after surgery
maximum urinary flow rate（Qmax）
Measuring the maximum urinary flow rate by a urodynamic study
Measured: within 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Jul 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiaming Wen, Dr., Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912349
- Sponsor's protocol ID
- 2020-525
- Status last verified
- May 2021
- First submitted
- 28 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Transurethral Split of the Prostate Versus Transurethral Resection of the Prostate for Treatment of Benign Prostatic Hyperplasia in a Small Prostate Volume: A Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT04912349
- Acronym / sponsor ID
- 2020-525
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 3 Jun 2021 (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.
Comparison of transurethral split of the prostate versus transurethral resection of the prostate for treatment of benign prostatic hyperplasia in a small prostate volume: A prospective controlled study
Detailed description
Transurethral resection of the prostate (TURP) was considered as the golden standard to treat benign prostatic hyperplasia (BPH) for decades. However, TURP was associated with low efficiency to alleviate the lower urinary tract symptoms and a significantly higher risk of bladder neck contracture (BNC) for patients with small-volume BPH. We aimed to compare the therapeutic effect of transurethral split of the prostate (TUSP) with TURP for patients with small-volume BPH (<30 ml).
In this study, some selected small-volume BPH patients were randomly divided into two groups (TUSP and TURP group). The patient's baseline characteristics and perioperative outcomes were recorded. The follow-up was made at 6 months, 1 year and 2 years after surgical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Procedure: TUSPPatients received the transurethral split of the prostate(TUSP) treatment. |
| Control Group | Active comparator | Procedure: TURPPatients received the transurethral resection of the prostate(TURP) treatment. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Benign prostatic hyperplasia patients with surgical indication
- Maximum flow rate <12ml/s
- Prostate volume <30ml
- The international prostate symptoms score>21
- Medication of α-adrenergic blockers for at least 3 months
Key exclusion criteria (4 listed)
- Acute prostatitis and urethritis
- Neurogenic bladder
- Abnormal prostate-specific antigen level
- Urethral injury history
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 |
|---|---|---|
| TUSPPatients received the transurethral split of the prostate(TUSP) treatment. | Procedure or surgery | Test Group |
| TURPPatients received the transurethral resection of the prostate(TURP) treatment. | Procedure or surgery | Control Group |
Primary outcome
international prostate symptoms score（IPSS）
Time frame: within 24 months after surgery
Measuring the International Prostate Symptoms Score by a questionnaire (which minimum value is zero and the maximum value is 35; higher scores mean a worse outcome)
maximum urinary flow rate（Qmax）
Time frame: within 24 months after surgery
Measuring the maximum urinary flow rate by a urodynamic study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Jiaming Wen, Dr. principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TUSP and TURP in people with Benign Prostatic Hyperplasia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 3 Jun 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiaming Wen, Dr. (+86-571-87783550, wenjiaming@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
international prostate symptoms score（IPSS） (time frame: within 24 months after surgery). The study lists 2 primary outcomes in all. 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 3 Jun 2021.