Prostate CancerBLANKETNCT04305379
Augmented BLAdder NecK rEconstruction Trial for Improved Urinary Function After Radical Prostatectomy
A study testing Augmented Bladder Neck Reconstruction and Standard Bladder Neck Reconstruction in people with Prostate Cancer and Urinary Incontinence, run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators are conducting a prospective, randomized trial to investigate whether patients randomized to receive an augmented bladder neck reconstruction (aBNR) at the time of robotic-assisted laparoscopic prostatectomy experience improved urinary function post-operatively compared to patients who undergo… Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Prostate Cancer, Urinary Incontinence, Surgery
- What is being tested?
- Augmented Bladder Neck Reconstruction and Standard Bladder Neck Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2020to 1 Mar 2021
- 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 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged 40 to 70 years of age with localized prostate cancer (clinical stage T2c or less, Gleason grade 5+5=10 or less without any evidence of distant metastases)
- Scheduled to undergo curative robot-assisted radical prostatectomy
Who cannot join
- Planned pre-operative or post-operative (within 1 month) androgen therapy
- Planned pre-operative or post-operative (within 1 month) radiation therapy
- History of spinal trauma or surgery to the brain or spinal cord
- Pre-operative history of stress urinary incontinence
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are conducting a prospective, randomized trial to investigate whether patients randomized to receive an augmented bladder neck reconstruction (aBNR) at the time of robotic-assisted laparoscopic prostatectomy experience improved urinary function post-operatively compared to patients who undergo prostatectomy with a standard BNR. An aBNR here consists of the autologous medial umbilical ligament sling as well as a bladder neck intussusception stitch. The standard BNR group will receive the intussusception stitch only.
Read the detailed description
A bladder neck reconstruction is a standard step in performing a radical prostatectomy. Over the years, various maneuvers to improve continence have been tried and studied including intussusception stitches and slings. Slings of various origins have been used by surgeons at the time of radical prostatectomy without consistent evidence demonstrating a benefit (vas deferens, biologic). However, use of the medial umbilical ligament to create a sling has not previously been studied in a randomized trial.
The medial umbilical ligaments are normally cut during intraperitoneal robotic-assisted laparoscopic radical prostatectomy to allow the surgeon access to the Retzius space between the bladder and pubic bone. To create a medial umbilical ligament autologous sling, the ligaments are dissected out and wrapped around the vesicourethral anastomosis.
The investigators are conducting a prospective, randomized trial to investigate whether patients randomized to receive an augmented bladder neck reconstruction (aBNR) at the time of robotic-assisted laparoscopic prostatectomy experience improved urinary function post-operatively compared to patients who undergo prostatectomy with a standard BNR. An aBNR here consists of the autologous medial umbilical ligament sling as well as a bladder neck intussusception stitch. The standard BNR group will receive the intussusception stitch only.
- Conditions
- Prostate Cancer, Urinary Incontinence, Surgery
- Being tested
- Augmented Bladder Neck Reconstruction, Standard Bladder Neck Reconstruction
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Bladder Neck ReconstructionProcedure or surgery
Augmented Bladder Neck Reconstruction including a Medial Umbilical Ligament Sling plus Intussusception
Standard Bladder Neck ReconstructionProcedure or surgery
Standard Bladder Neck Reconstruction with Intussusception Only
| Study group | Role | What they receive |
|---|---|---|
| Augmented Bladder Neck Reconstruction | Experimental | Augmented Bladder Neck Reconstruction (Sling + Intussusception) Receives: Procedure: Augmented Bladder Neck Reconstruction |
| Standard Bladder Neck Reconstruction | Active comparator | Standard Bladder Neck Reconstruction (Intussusception Only) Receives: Procedure: Standard Bladder Neck Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
EPIC Urinary Incontinence subscale score
Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).
Measured: 1 Month
Secondary outcomes (4)
EPIC Urinary Incontinence subscale score
Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).
Measured: 2 Weeks
EPIC Urinary Incontinence subscale score
Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).
Measured: 3 Months
EPIC Urinary Incontinence subscale score
Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).
Measured: 6 Months
EPIC Urinary Incontinence subscale score
Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start16 Jan 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Why it stopped: Stopped due to COVID-19 pandemic, low priority among initiatives and officially terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamad E Allaf, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305379
- Sponsor's protocol ID
- IRB00208651
- Acronym
- BLANKET
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2020
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- 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 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented BLAdder NecK rEconstruction Trial for Improved Urinary Function After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT04305379
- Acronym / sponsor ID
- BLANKET / IRB00208651
- Conditions
- Prostate Cancer, Urinary Incontinence, Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped due to COVID-19 pandemic, low priority among initiatives and officially terminated.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 12 Mar 2020 (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.
The investigators are conducting a prospective, randomized trial to investigate whether patients randomized to receive an augmented bladder neck reconstruction (aBNR) at the time of robotic-assisted laparoscopic prostatectomy experience improved urinary function post-operatively compared to patients who undergo prostatectomy with a standard BNR. An aBNR here consists of the autologous medial umbilical ligament sling as well as a bladder neck intussusception stitch. The standard BNR group will receive the intussusception stitch only.
Detailed description
A bladder neck reconstruction is a standard step in performing a radical prostatectomy. Over the years, various maneuvers to improve continence have been tried and studied including intussusception stitches and slings. Slings of various origins have been used by surgeons at the time of radical prostatectomy without consistent evidence demonstrating a benefit (vas deferens, biologic). However, use of the medial umbilical ligament to create a sling has not previously been studied in a randomized trial.
The medial umbilical ligaments are normally cut during intraperitoneal robotic-assisted laparoscopic radical prostatectomy to allow the surgeon access to the Retzius space between the bladder and pubic bone. To create a medial umbilical ligament autologous sling, the ligaments are dissected out and wrapped around the vesicourethral anastomosis.
The investigators are conducting a prospective, randomized trial to investigate whether patients randomized to receive an augmented bladder neck reconstruction (aBNR) at the time of robotic-assisted laparoscopic prostatectomy experience improved urinary function post-operatively compared to patients who undergo prostatectomy with a standard BNR. An aBNR here consists of the autologous medial umbilical ligament sling as well as a bladder neck intussusception stitch. The standard BNR group will receive the intussusception stitch only.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmented Bladder Neck Reconstruction | Experimental | Procedure: Augmented Bladder Neck ReconstructionAugmented Bladder Neck Reconstruction (Sling + Intussusception) |
| Standard Bladder Neck Reconstruction | Active comparator | Procedure: Standard Bladder Neck ReconstructionStandard Bladder Neck Reconstruction (Intussusception Only) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men aged 40 to 70 years of age with localized prostate cancer (clinical stage T2c or less, Gleason grade 5+5=10 or less without any evidence of distant metastases)
- Scheduled to undergo curative robot-assisted radical prostatectomy
Key exclusion criteria (4 listed)
- Planned pre-operative or post-operative (within 1 month) androgen therapy
- Planned pre-operative or post-operative (within 1 month) radiation therapy
- History of spinal trauma or surgery to the brain or spinal cord
- Pre-operative history of stress urinary incontinence
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 |
|---|---|---|
| Augmented Bladder Neck ReconstructionAugmented Bladder Neck Reconstruction including a Medial Umbilical Ligament Sling plus Intussusception | Procedure or surgery | Augmented Bladder Neck Reconstruction |
| Standard Bladder Neck ReconstructionStandard Bladder Neck Reconstruction with Intussusception Only | Procedure or surgery | Standard Bladder Neck Reconstruction |
Primary outcome
EPIC Urinary Incontinence subscale score
Time frame: 1 Month
Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).
4 secondary outcomes
EPIC Urinary Incontinence subscale score
Time frame: 2 Weeks
EPIC Urinary Incontinence subscale score
Time frame: 3 Months
EPIC Urinary Incontinence subscale score
Time frame: 6 Months
EPIC Urinary Incontinence subscale score
Time frame: 12 Months
Results and safety
The study was stopped early (reason given: Stopped due to COVID-19 pandemic, low priority among initiatives and officially terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruiting
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
Malignant Prostate Neoplasm
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
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.
Mohamad E Allaf, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Bladder Neck Reconstruction and Standard Bladder Neck Reconstruction in people with Prostate Cancer and Urinary Incontinence, run by Johns Hopkins University 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 2 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: stopped early, as of the sponsor's last update on 17 Mar 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 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: Stopped due to COVID-19 pandemic, low priority among initiatives and officially terminated.). 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?
EPIC Urinary Incontinence subscale score (time frame: 1 Month). 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 17 Mar 2021.