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

Study Overview
=================
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.

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

Conditions
-----------------
Stress Incontinence, Female

Intervention / Treatment
-----------------
* Device: Single incision sling
* Drug: Bulkamid bulking agent


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single incision sling group<br>The patient will receive Altis mini-incision sling for treatment of occult SUI | Device: Single incision sling<br>* Single incision sling is used to treat occult SUI<br>|
| Urethral bulking group<br>The patient will receive Bulkamid urethral bulking agent for treatment of SUI | Drug: Bulkamid bulking agent<br>* Urethral bulking by Bulkamid is used to treat occult SUI<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |