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

NCT05210738 | Completed FDA Drug FDA Device

• 1 other identifier: E21-53
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Stress Incontinence, Female

Outcome Measures

Primary Outcomes (3)

• 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 (1)

• The rate of complications in both groups which includes adverse events, rate of urine retention with prolonged catheterization, and UTI.

  one year after surgery

Study Arms (2)

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

Single incision sling DEVICE

Single incision sling is used to treat occult SUI

Single incision sling group

Bulkamid bulking agent DRUG

Urethral bulking by Bulkamid is used to treat occult SUI

Urethral bulking group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced prolapse and preoperative evaluation showed occult stress incontinence

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Christ Hospital: lead

Study Sites (1)

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed Abdelaziz

  The Christ Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 27, 2022
• Study Start: January 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)