Single-incision Sling vs Urethral Bulking During Prolapse... | NCT05210738

Studies
Single-incision Sling vs Urethral Bulking During Prolapse Surgery for Occult Stress Incontinence

NCT05210738

Sponsor

The Christ Hospital

Status

Completed

Last Update Posted

Jan 27, 2022Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Stress Incontinence, Female

Interventions

Single incision sling
Bulkamid bulking agent

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jun 1, 2021Actual

Completion Date

Jun 1, 2021Actual

First Submitted Date

Jan 14, 2022

First Submission Date that Met QC Criteria

Jan 14, 2022

First Posted Date

Jan 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2022

Last Update Posted Date

Jan 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim is to compare outcomes of two different procedures to prevent occult stress urinary incontinence (SUI) in patients who are having pelvic organ prolapse surgeries

Detailed Description

The aim is to compare outcomes of two different procedures to prevent occult stress urinary incontinence (SUI) in patients who are having pelvic organ prolapse surgeries. Charts will be reviewed for patients who had single- incision sling or urethral bulking injection with other prolapse surgeries to address occult stress incontinence at The Christ Hospital from the period of January 2019 to June 2021. Patients who didn't have any occult stress incontinence pre-operatively and didn't receive any anti-incontinence procedure during their prolapse surgery will be included as a control group. Surgical details, adverse events and postoperative voiding times will be collected from the chart. Patients will be contacted by a telephone to administer a validated questionnaire; a 3-day bladder diary to quantify urinary incontinence will be send to the patient to complete and return by mail.

The purpose of the study is to investigate whether urethral bulking is as effective as single- incision sling in treating occult stress incontinence.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single incision sling group		The patient will receive Altis mini-incision sling for treatment of occult SUI	Device: Single incision sling
Urethral bulking group		The patient will receive Bulkamid urethral bulking agent for treatment of SUI	Drug: Bulkamid bulking agent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Single incision sling	Device	Single incision sling is used to treat occult SUI	Single incision sling group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Urinary Distress Inventory, Short Form (UDI-6)		one year after surgery
Incontinence Impact Questionnaire, Short Form (IIQ-7)		one year after surgery
Voiding diary		one year after surgery

Secondary Outcomes

Measure	Description	Time Frame
The rate of complications in both groups which includes adverse events, rate of urine retention with prolonged catheterization, and UTI.		one year after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-Females who are 18 years or old who were scheduled to either urethral bulking (Bulkamid) or single-incision sling (Altis sling) to address occult SUI with prolapse surgery. All patients reported no history of SUI preoperatively and during office physical exam, positive SUI was demonstrated during prolapse reduction.
Females who are 18 years or old who didn't have occult stress incontinence before their prolapse surgery and didn't receive any stress incontinence surgery during their prolapse surgery during the same period will be included as a control group.
English speaking patients.

Exclusion Criteria:

Patients who had either single-incision sling or urethral bulking with documented preoperative history of stress incontinence. Patients with a history of previous surgery for SUI.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with advanced prolapse and preoperative evaluation showed occult stress incontinence

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Abdelaziz	The Christ Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Christ Hospital		Cincinnati	Ohio	45219	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014550	Urinary Incontinence, Stress

Ancestor Terms

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

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Browse Branches

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