Benign Prostatic HyperplasiaNCT01073241
Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate
A study testing transurethral ventral wall of urethra-preserving enucleation of prostate and transurethral prostatic resection in people with Benign Prostatic Hyperplasia, run by Southwest Hospital, China at 1 site in China.
Trial summary
In this study, the investigators designed a randomized and double-blind prospective trial to evaluate the efficiency and safety of the investigators new approach-transurethral ventral wall of urethra-preserving enucleation of prostate in comparison with TURP for the hyperplasia weighing more than 45 g. Read more about this study
- Who is it for?
- Ages 45 to 90 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- transurethral ventral wall of urethra-preserving enucleation of prostate and transurethral prostatic resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2010to Feb 2012
- 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 45 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BPH was diagnosed by DRE, Ultrasonography, CT or MR
- IPSS:>15
- Qmax:≤10ml/s and volume of bladder >200ml
- The weight of prostate >45g
Who cannot join
- Patient with other aggravating malignant tumor
- Total-PSA>20ng/ml, or 4<total-PSA<20ng/ml but the value of Free-PSA/total-PSA<0.16
- The maximum press of detrusor muscle <15cmH2O
- Patient with urethral stricture
- Patient with urinary infection
- Patient with Nervous System Disease
- Patient with surgical contraindication, such as severe cardiac or lung disease, diaphragmatic hernias, and so on
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Urology, Southwest Hospital
Shapinba, Chongqing Municipality, 400038
About this study
In this study, the investigators designed a randomized and double-blind prospective trial to evaluate the efficiency and safety of the investigators new approach-transurethral ventral wall of urethra-preserving enucleation of prostate in comparison with TURP for the hyperplasia weighing more than 45 g.
Read the detailed description
Although in recent dozen of years, laser operation and other safer minimally invasive surgeries have been well-developed, transurethral resection of the prostate (TURP) is still the gold standard for the surgical treatment of benign prostatic hyperplasia, despite of its various complications, and not suitable for the hyperplasia over 80 g which should be resected under open surgery. In this study, we design a randomized and double-blind prospective trial to evaluate the efficiency and safety of our new approach-transurethral ventral wall of urethra-preserving enucleation of prostate in comparison with TURP for the hyperplasia weighing more than 45 g.Urodynamic examination [maximum flow rate (QMax), detrusor pressure, and so on], transrectal color Doppler ultrasonography for the prostate, blood routine, blood electrolyte, prostate specific antigen (PSA), International Prostate Symptom Score (IPSS), the quality of life (Qol), blood loss during operation, and the weight of resected prostate were studied before and after the operation.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- transurethral ventral wall of urethra-preserving enucleation of prostate, transurethral prostatic resection
- Keywords
- benign prostatic hyperplasia, Transurethral Resection of Prostate, transurethral enucleation of prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transurethral ventral wall of urethra-preserving enucleation of prostateProcedure or surgery
Also called TUEP
The patients' ventral wall of the prostate urethra was preserved and enucleation of prostate was performed for the left hyperplasia in the envelop.
transurethral prostatic resectionProcedure or surgery
Also called TURP
The patients' prostate was resected with the conventional Nesbit TURP
| Study group | Role | What they receive |
|---|---|---|
| transurethral prostatic resection | Active comparator | The patients' prostate was resected with the conventional Nesbit TURP. Receives: Procedure: transurethral prostatic resection |
| ventral wall of urethra-preserving enucleation of prostate | Experimental | The patients' ventral wall of the prostate urethra was preserved and enucleation of prostate was performed for the left hyperplasia in the envelop. Receives: Procedure: transurethral ventral wall of urethra-preserving enucleation of prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
urodynamic study
Measured: before operation and the third month, 6th month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Investigators
- Zhang Jiahua, Study director, Urology Institute of Southwest Hospital, Chongqin, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073241
- Sponsor's protocol ID
- SouthwestH
- Status last verified
- Feb 2010
- First submitted
- 22 Feb 2010
- Last updated
- 15 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate
- ClinicalTrials.gov ID
- NCT01073241
- Acronym / sponsor ID
- SouthwestH
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- benign prostatic hyperplasia, Transurethral Resection of Prostate, transurethral enucleation of prostate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 23 Feb 2010 (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.
In this study, the investigators designed a randomized and double-blind prospective trial to evaluate the efficiency and safety of the investigators new approach-transurethral ventral wall of urethra-preserving enucleation of prostate in comparison with TURP for the hyperplasia weighing more than 45 g.
Detailed description
Although in recent dozen of years, laser operation and other safer minimally invasive surgeries have been well-developed, transurethral resection of the prostate (TURP) is still the gold standard for the surgical treatment of benign prostatic hyperplasia, despite of its various complications, and not suitable for the hyperplasia over 80 g which should be resected under open surgery. In this study, we design a randomized and double-blind prospective trial to evaluate the efficiency and safety of our new approach-transurethral ventral wall of urethra-preserving enucleation of prostate in comparison with TURP for the hyperplasia weighing more than 45 g.Urodynamic examination [maximum flow rate (QMax), detrusor pressure, and so on], transrectal color Doppler ultrasonography for the prostate, blood routine, blood electrolyte, prostate specific antigen (PSA), International Prostate Symptom Score (IPSS), the quality of life (Qol), blood loss during operation, and the weight of resected prostate were studied before and after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transurethral prostatic resection | Active comparator | Procedure: transurethral prostatic resectionThe patients' prostate was resected with the conventional Nesbit TURP. |
| ventral wall of urethra-preserving enucleation of prostate | Experimental | Procedure: transurethral ventral wall of urethra-preserving enucleation of prostateThe patients' ventral wall of the prostate urethra was preserved and enucleation of prostate was performed for the left hyperplasia in the envelop. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BPH was diagnosed by DRE, Ultrasonography, CT or MR
- IPSS:>15
- Qmax:≤10ml/s and volume of bladder >200ml
- The weight of prostate >45g
Key exclusion criteria (7 listed)
- Patient with other aggravating malignant tumor
- Total-PSA>20ng/ml, or 4<total-PSA<20ng/ml but the value of Free-PSA/total-PSA<0.16
- The maximum press of detrusor muscle <15cmH2O
- Patient with urethral stricture
- Patient with urinary 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 |
|---|---|---|
| transurethral ventral wall of urethra-preserving enucleation of prostateAlso: TUEPThe patients' ventral wall of the prostate urethra was preserved and enucleation of prostate was performed for the left hyperplasia in the envelop. | Procedure or surgery | ventral wall of urethra-preserving enucleation of prostate |
| transurethral prostatic resectionAlso: TURPThe patients' prostate was resected with the conventional Nesbit TURP | Procedure or surgery | transurethral prostatic resection |
Primary outcome
urodynamic study
Time frame: before operation and the third month, 6th month after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2010.
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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.
Zhang Jiahua study director
Urology Institute of Southwest Hospital, Chongqin, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transurethral ventral wall of urethra-preserving enucleation of prostate and transurethral prostatic resection in people with Benign Prostatic Hyperplasia, run by Southwest Hospital, China 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 4 inclusion and 7 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 15 Mar 2010. 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?
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?
urodynamic study (time frame: before operation and the third month, 6th month after operation). 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 15 Mar 2010.