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Completed

NCT Number: NCT05210738

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single incision sling

Device

Single incision sling is used to treat occult SUI

Bulkamid bulking agent

Drug

Urethral bulking by Bulkamid is used to treat occult SUI

Primary outcomes

  1. Urinary Distress Inventory, Short Form (UDI-6)

    Time frame: one year after surgery

  2. Incontinence Impact Questionnaire, Short Form (IIQ-7)

    Time frame: one year after surgery

  3. Voiding diary

    Time frame: one year after surgery

Secondary outcomes

  1. The rate of complications in both groups which includes adverse events, rate of urine retention with prolonged catheterization, and UTI.

    Time frame: one year after surgery

Sponsors and collaborators

Lead sponsor

The Christ Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2022
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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