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

A Cohort Observational Study Comparing the Outcomes of Single-incision Sling vs Urethral Bulking During Prolapse Surgery for Occult Stress Incontinence

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

Study Overview

• Status: Completed
• Conditions: Stress Incontinence, Female
• Intervention / Treatment: Device: Single incision sling; Drug: Bulkamid bulking agent

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced prolapse and preoperative evaluation showed occult stress incontinence

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single incision sling group; The patient will receive Altis mini-incision sling for treatment of occult SUI	Device: Single incision sling; Single incision sling is used to treat occult SUI
Urethral bulking group; The patient will receive Bulkamid urethral bulking agent for treatment of SUI	Drug: Bulkamid bulking agent; Urethral bulking by Bulkamid is used to treat occult SUI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The Christ Hospital
• Investigators: Principal Investigator: Ahmed Abdelaziz, The Christ Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Urinary Incontinence; Prolapse; Urinary Incontinence, Stress
• Other Study ID Numbers: E21-53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes