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Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure

Primary Purpose

Stress Urinary Incontinence

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Urodynamic testing with and without pudendal nerve stimulation
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female aged 18 years old or older Capable of understanding the clinical study procedures and giving informed consent Willing and able to undergo the study procedure Diagnosis of SUI or stress predominant mixed incontinence, for at least 6 months Provided authorization to use and disclose information for research purposes Exclusion Criteria: Predominant urge incontinence per patient report or medical record Previously diagnosed with Interstitial Cystitis Active symptomatic uncontrolled bladder instability as determined by the investigator Regularly or intermittently used a urethral catheter Active bladder cancer (currently undergoing or scheduled to undergo treatment for bladder cancer). Previous radiation treatment in the pelvic floor Three or more culture-proven bacterial UTIs in the last 12 months History or symptoms of cystocele, enterocele or rectocele of grade 3 or 4. Per the medical record or as determined by the investigator Current infection (urethritis, cystitis or vaginitis) as determined by investigator. Active herpes genitalis Unevaluated hematuria BMI ≥ 35 Currently taking, or has taken within 4 weeks prior to the screening/baseline visit, pharmacological treatment for SUI (including but not limited to, alpha adrenergics, and tricyclic antidepressants) Severe or uncontrolled diabetes, (defined as being a diabetic with a hemoglobin A1c of ≥10%) per patient medical record. History of drug/alcohol abuse, mental dysfunction, or other factors limiting her ability to cooperate fully Pregnancy test with positive result during screening or women who are breastfeeding Women who are pregnant and/or have given birth in the previous 12 months Have implanted neurostimulators, pacemakers, or defibrillators Known systemic neurological dysfunctions Severe coagulation disorders Medically unstable at time of study and unsafe to undergo urodynamic testing (UDT) as determined by the investigator Presence of an artificial urinary sphincter Any medical condition (e.g. Multiple Sclerosis, spinal cord injury, mobility) or uncontrolled chronic disease (e.g. renal diseases that requires dialysis) that would interfere with the patient's ability to comply with the protocol and/or may affect the outcome of this study or safety of the subject as determined by the investigator

Sites / Locations

  • Beaumont Hospital-Royal Oak

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Urodynamic testing and LLP with and without pudendal nerve stimulation

Arm Description

Commercially available stimulation needles will be inserted into the peri-urethral space targeting the perineal branch of the pudendal nerve. An external neurostimulator settings will be adjusted to deliver acute stimulation. Urodynamic testing will be completed by filling the bladder to a set volume and observing for urinary leakage. The assessment will be completed with stimulation turned on and off. The neurostimulator device settings will be adjusted by the investigator to stay within safe and comfortable levels for each individual study participant.

Outcomes

Primary Outcome Measures

The effect of acute peri-urethral neurostimulation on intra-urethral pressure.
Intra-urethral pressure (measured in cmH2O) will be recorded with stimulation on and off.

Secondary Outcome Measures

Safety and tolerability will be assessed in relation to the incidence of adverse events occurring within one week of stimulation visit.
Safety and tolerability of peri-urethral stimulation will be assessed in related to the incidence of adverse events reported.
Valsalva leak point pressure (LLP) in response to acute peri-urethral neurostimulation compared to no stimulation
Leak point pressure (measured in cmH20) will be collected during neurostimulation and without neurostimulation.

Full Information

First Posted
May 13, 2023
Last Updated
August 4, 2023
Sponsor
William Beaumont Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT05900570
Brief Title
Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure
Official Title
The Effect of Acute Peri-Urethral Neurostimulation on Intra-Urethral Pressure In Women With Stress Urinary Incontinence (SUI) - Urodynamic Early Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this early feasibility prospective study is to gain initial understanding of the effect of acute peri-urethral neurostimulation on the perineal nerves on intra-urethral pressure.
Detailed Description
In this study intra-urethral pressure data will be collected and analyzed with and without peri-urethral neurostimulation. This is a single arm feasibility study of women diagnosed with stress urinary incontinence. The data collected may help researchers have a better understanding of the effect, if any, on neurostimulation on stress or mixed urinary incontinence. After informed consent and all eligibility criteria are met, enrolled participants will be brought in for a stimulation visit. At the stimulation visit, participants will undergo urodynamic testing with and without stimulation. A prophylactic antibiotic will be given before the procedure and a local anesthetic cream will be applied topically to the peri-urethral area. The participant will be prepped for urodynamic testing per protocol. Commercially available simulation needles and external neurostimulator device will be used to perform peri-urethral neurostimulation of the perineal branch of the pudendal nerve. The amplitude will gradually be increased and intra-urethral pressure will be recorded. Stimulation parameters such as amplitude, pulse-width, and frequency will be explored to assess their effect on urethral pressure. Amplitude progressively will be increased until discomfort is noted, no further pressure increases are observed, or maximum output is achieved. When a consistent pressure is observed, record intra-urethral pressure measurements with stimulation on and off. Next, Leak Point Pressure (LPP) testing with and without stimulation will be completed. Start the urodynamic saline infusion until desired volume is reached. Observe for urinary leakage. This will be repeated with the stimulation on.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants who meet all eligibility criteria will be enrolled in the study and undergo urodynamic testing and LPP with and without neurostimulation
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Urodynamic testing and LLP with and without pudendal nerve stimulation
Arm Type
Experimental
Arm Description
Commercially available stimulation needles will be inserted into the peri-urethral space targeting the perineal branch of the pudendal nerve. An external neurostimulator settings will be adjusted to deliver acute stimulation. Urodynamic testing will be completed by filling the bladder to a set volume and observing for urinary leakage. The assessment will be completed with stimulation turned on and off. The neurostimulator device settings will be adjusted by the investigator to stay within safe and comfortable levels for each individual study participant.
Intervention Type
Diagnostic Test
Intervention Name(s)
Urodynamic testing with and without pudendal nerve stimulation
Intervention Description
A urodynamic test with and without neurostimulation will be conducted. The external neurostimulator device settings will be adjusted to deliver acute nerve stimulation per the individual tolerance level to assess the effect on urethral pressure. A leak point pressure (LLP) during Valsalva maneuver will be assessed with and without acute nerve stimulation.
Primary Outcome Measure Information:
Title
The effect of acute peri-urethral neurostimulation on intra-urethral pressure.
Description
Intra-urethral pressure (measured in cmH2O) will be recorded with stimulation on and off.
Time Frame
At stimulation visit, 1 day
Secondary Outcome Measure Information:
Title
Safety and tolerability will be assessed in relation to the incidence of adverse events occurring within one week of stimulation visit.
Description
Safety and tolerability of peri-urethral stimulation will be assessed in related to the incidence of adverse events reported.
Time Frame
One week after completing the stimulation visit
Title
Valsalva leak point pressure (LLP) in response to acute peri-urethral neurostimulation compared to no stimulation
Description
Leak point pressure (measured in cmH20) will be collected during neurostimulation and without neurostimulation.
Time Frame
At stimulation visit, 1 day

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Born female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female aged 18 years old or older Capable of understanding the clinical study procedures and giving informed consent Willing and able to undergo the study procedure Diagnosis of SUI or stress predominant mixed incontinence, for at least 6 months Provided authorization to use and disclose information for research purposes Exclusion Criteria: Predominant urge incontinence per patient report or medical record Previously diagnosed with Interstitial Cystitis Active symptomatic uncontrolled bladder instability as determined by the investigator Regularly or intermittently used a urethral catheter Active bladder cancer (currently undergoing or scheduled to undergo treatment for bladder cancer). Previous radiation treatment in the pelvic floor Three or more culture-proven bacterial UTIs in the last 12 months History or symptoms of cystocele, enterocele or rectocele of grade 3 or 4. Per the medical record or as determined by the investigator Current infection (urethritis, cystitis or vaginitis) as determined by investigator. Active herpes genitalis Unevaluated hematuria BMI ≥ 35 Currently taking, or has taken within 4 weeks prior to the screening/baseline visit, pharmacological treatment for SUI (including but not limited to, alpha adrenergics, and tricyclic antidepressants) Severe or uncontrolled diabetes, (defined as being a diabetic with a hemoglobin A1c of ≥10%) per patient medical record. History of drug/alcohol abuse, mental dysfunction, or other factors limiting her ability to cooperate fully Pregnancy test with positive result during screening or women who are breastfeeding Women who are pregnant and/or have given birth in the previous 12 months Have implanted neurostimulators, pacemakers, or defibrillators Known systemic neurological dysfunctions Severe coagulation disorders Medically unstable at time of study and unsafe to undergo urodynamic testing (UDT) as determined by the investigator Presence of an artificial urinary sphincter Any medical condition (e.g. Multiple Sclerosis, spinal cord injury, mobility) or uncontrolled chronic disease (e.g. renal diseases that requires dialysis) that would interfere with the patient's ability to comply with the protocol and/or may affect the outcome of this study or safety of the subject as determined by the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Waldvogel, BSN
Phone
248-551-2572
Email
Angela.Waldvogel@corewellhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Giordano, BSN
Phone
5862424028
Email
jennifer.giordano@corewellhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Peters, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Hospital-Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

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Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure

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