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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-06-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Stress Incontinence, Female

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Single incision sling group

The patient will receive Altis mini-incision sling for treatment of occult SUI

Single incision sling

Intervention Type DEVICE

Single incision sling is used to treat occult SUI

Urethral bulking group

The patient will receive Bulkamid urethral bulking agent for treatment of SUI

Bulkamid bulking agent

Intervention Type DRUG

Urethral bulking by Bulkamid is used to treat occult SUI

Interventions

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Single incision sling

Single incision sling is used to treat occult SUI

Intervention Type DEVICE

Bulkamid bulking agent

Urethral bulking by Bulkamid is used to treat occult SUI

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes