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

Completed

• Conditions: Stress Incontinence, Female
• Interventions: Device: Single incision sling; Drug: Bulkamid bulking agent

• Registration Number: NCT05210738
• Lead Sponsor: The Christ Hospital

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2022-01
• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-14
• Last Update Submitted: 2022-01-14
• Study First Posted: 2022-01-27
• Last Update Posted: 2022-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single incision sling group	Single incision sling	The patient will receive Altis mini-incision sling for treatment of occult SUI
Urethral bulking group	Bulkamid bulking agent	The patient will receive Bulkamid urethral bulking agent for treatment of SUI

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States