## Protocol Section
### Identification Module
**NCT ID:** NCT06429228

**Brief Title:** Comparison of 1 Versus 2 Days Post-Operative Catheterization After Anterior Colporrhaphy

**Official Title:** Comparison of 1 Versus 2 Days Post-Operative Catheterization After Anterior Colporrhaphy

#### Organization Study ID Info
**ID:** CAT_273219
#### Organization
**Class:** OTHER
**Full Name:** IRCCS San Raffaele
### Status Module
#### Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-04-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-24
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** IRCCS San Raffaele

#### Responsible Party

**Investigator Affiliation:** IRCCS San Raffaele

**Investigator Full Name:** Stefano Salvatore

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Patients who undergo anterior vaginal wall plastic surgery and place the bladder catheter during surgery are selected. The purpose of the study is to evaluate the presence of statistically significant differences in bladder catheter repositioning within 12 hours after bladder catheter removal in the group of patients in whom the bladder catheter is removed on postoperative day I or II.

Secondary outcomes include evaluation of the incidence of urinary tract infections, number of hospitalization days and total hospitalization costs for patients undergoing anterior vaginal wall surgery in patients in whom the bladder catheter is removed on postoperative day I or II.

### Conditions Module

**Conditions:**

- Catheter Related Complication

- Anterior Vaginal Wall Prolapse

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: Catheter removal after surgery

**Label:** Catheter removal in postoperative day I

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Procedure: Catheter removal after surgery

**Label:** Catheter removal in postoperative day II

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Catheter removal in postoperative day I

- Catheter removal in postoperative day II

**Description:** Removal of catheter placed during the procedure in first or second post-surgical days.

**Name:** Catheter removal after surgery

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** After removal of the bladder catheter, on postoperative day I or II, the appearance of urinary urge will be assessed and, in case of spontaneous urination, the quantity of urine will be measured. In the event that after the waiting time of 6 hours an adequate urination stimulus does not arise, we will proceed with an ultrasound evaluation of bladder stagnation (RV) and the application of the department protocol, as follows:

* if the sum of diuresis and RV is between 500 and 1000 cc, extemporaneous catheterization and re-evaluation after 4 hours are indicated
* if the sum of diuresis and RV is \> 1000cc, positioning of a bladder catheter and maintenance of the same for 5-7 days with subsequent evaluation is indicated.

**Measure:** differences in bladder catheter repositioning within 12 hours after bladder catheter removal

**Time Frame:** 12 hours

#### Secondary Outcomes

**Description:** Before removing the catheter, a chemical-physical examination will be carried out; if this is positive, urine culture will be carried out. The diagnosis of urinary tract infection will be made with leukocyturia greater than 25 cells per field, positivity for urinary nitrite, presence of at least 20 bacteria per field, bacteriuria and/or more than 100,000 colony forming units associated with at least one of the following signs (fever, dysuria, increased urinary frequency, suprapubic pain, burning on urination or worsening of urinary incontinence). Patients with a positive culture and/or who show symptoms attributable to urinary tract infection will be subjected to antibiotic therapy.

**Measure:** incidence of urinary tract infections for patients undergoing cystopexy surgery in patients in whom the bladder catheter is removed on postoperative day I or II.

**Time Frame:** During hospital stay

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Women 18 years of age or older
* Patients who are candidates for cystopexy surgery
* Patients who have consented to the signing of the Informed Consent

Exclusion Criteria:

* Micturition dysfunction with preoperative bladder stagnation \> 200 cc at pessary evaluation
* History of recurrent cystitis
* Positive preoperative urine culture
* Azotemia \> 40 mg/dL or creatininemia \> 1 mg/dL
* Not collected signed consent endorsed
* Diabetes mellitus
* Contraindications to transurethral bladder catheterization
* Major protocol violations due to unforeseen intraoperative complications (bladder and/or rectal damage, severe bleeding with need for urinary monitoring)

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** salvatore.stefano@hsr.it

**Name:** Stefano Salvatore

**Phone:** 0226434930

**Role:** CONTACT

**Contact 2:**

**Email:** benini.vittoria@hsr.it

**Name:** Vittoria Benini

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Milan

**Contacts:**

***Contact 1:***

- **Email:** salvatore.stefano@hsr.it

- **Name:** Stefano Salvatore

- **Role:** CONTACT

***Contact 2:***

- **Email:** benini.vittoria@hsr.it

- **Name:** Vittoria Benini

- **Role:** CONTACT

**Country:** Italy

**Facility:** IRCCS San Raffaele Hospital

**Status:** RECRUITING

**Zip:** 20132

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14261

- Name: Prolapse

- Relevance: HIGH

- As Found: Prolapse

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011391

- Term: Prolapse

### Misc Info Module

- Version Holder: 2024-05-31
