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

Stress Incontinence, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05210738
• Other study ID #: E21-53
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: January 2022
• Source: The Christ Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prolapse
• Stress Incontinence, Female
• Urinary Incontinence, Stress

Intervention

Device:
• Single incision sling
Single incision sling is used to treat occult SUI

Drug:
• Bulkamid bulking agent
Urethral bulking by Bulkamid is used to treat occult SUI

Locations

Country	Name	City	State
United States	The Christ Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Christ Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Distress Inventory, Short Form (UDI-6)		one year after surgery
Primary	Incontinence Impact Questionnaire, Short Form (IIQ-7)		one year after surgery
Primary	Voiding diary		one year after surgery
Secondary	The rate of complications in both groups which includes adverse events, rate of urine retention with prolonged catheterization, and UTI.		one year after surgery