## Protocol Section
### Identification Module
**NCT ID:** NCT04305379

**Acronym:** BLANKET

**Brief Title:** Augmented BLAdder NecK rEconstruction Trial for Improved Urinary Function After Radical Prostatectomy

**Official Title:** Augmented BLAdder NecK rEconstruction Trial for Improved Urinary Function After Radical Prostatectomy

#### Organization Study ID Info
**ID:** IRB00208651
#### Organization
**Class:** OTHER
**Full Name:** Johns Hopkins University
### Status Module
#### Completion Date
**Date:** 2021-03-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-03-17

**Type:** ACTUAL

**Last Update Submit Date:** 2021-03-15

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2021-03-01

**Type:** ACTUAL

#### Start Date
**Date:** 2020-01-16

**Type:** ACTUAL

**Status Verified Date:** 2021-03

#### Study First Post Date
**Date:** 2020-03-12
**Type:** ACTUAL
**Study First Submit Date:** 2020-03-10
**Study First Submit QC Date:** 2020-03-10
**Why Stopped:** Stopped due to COVID-19 pandemic, low priority among initiatives and officially terminated.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Johns Hopkins University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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 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.

### Conditions Module

**Conditions:**

- Prostate Cancer

- Urinary Incontinence

- Surgery

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** The surgeon will be masked until the time of bladder neck reconstruction during the radical prostatectomy.

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 31

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Augmented Bladder Neck Reconstruction (Sling + Intussusception)

**Intervention Names:**

- Procedure: Augmented Bladder Neck Reconstruction

**Label:** Augmented Bladder Neck Reconstruction

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Standard Bladder Neck Reconstruction (Intussusception Only)

**Intervention Names:**

- Procedure: Standard Bladder Neck Reconstruction

**Label:** Standard Bladder Neck Reconstruction

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Augmented Bladder Neck Reconstruction

**Description:** Augmented Bladder Neck Reconstruction including a Medial Umbilical Ligament Sling plus Intussusception

**Name:** Augmented Bladder Neck Reconstruction

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Standard Bladder Neck Reconstruction

**Description:** Standard Bladder Neck Reconstruction with Intussusception Only

**Name:** Standard Bladder Neck Reconstruction

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**Measure:** EPIC Urinary Incontinence subscale score

**Time Frame:** 1 Month

#### Secondary Outcomes

**Description:** 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).

**Measure:** EPIC Urinary Incontinence subscale score

**Time Frame:** 2 Weeks

**Description:** 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).

**Measure:** EPIC Urinary Incontinence subscale score

**Time Frame:** 3 Months

**Description:** 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).

**Measure:** EPIC Urinary Incontinence subscale score

**Time Frame:** 6 Months

**Description:** 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).

**Measure:** EPIC Urinary Incontinence subscale score

**Time Frame:** 12 Months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

**Maximum Age:** 70 Years

**Minimum Age:** 40 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Baltimore

**Country:** United States

**Facility:** Johns Hopkins Hospital

**State:** Maryland

**Zip:** 21287

#### Overall Officials

**Official 1:**

**Affiliation:** Johns Hopkins University

**Name:** Mohamad E Allaf, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000014555

- Term: Urination Disorders

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000059411

- Term: Lower Urinary Tract Symptoms

- ID: D000020924

- Term: Urological Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17299

- Name: Urinary Incontinence

- Relevance: HIGH

- As Found: Urinary Incontinence

- ID: M7936

- Name: Enuresis

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17305

- Name: Urination Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M29464

- Name: Lower Urinary Tract Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M22659

- Name: Urological Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014549

- Term: Urinary Incontinence

### Misc Info Module

- Version Holder: 2024-05-24
