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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05210738
Enrollment
60
Registered
2022-01-27
Start date
2019-01-01
Completion date
2021-06-01
Last updated
2022-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Incontinence, Female

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.

Interventions

DEVICESingle incision sling

Single incision sling is used to treat occult SUI

DRUGBulkamid bulking agent

Urethral bulking by Bulkamid is used to treat occult SUI

Sponsors

The Christ Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Urinary Distress Inventory, Short Form (UDI-6)one year after surgery
Incontinence Impact Questionnaire, Short Form (IIQ-7)one year after surgery
Voiding diaryone year after surgery

Secondary

MeasureTime 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026