RECRUITING

Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effect of Acute Peri-Urethral Neurostimulation on Intra-Urethral Pressure In Women With Stress Urinary Incontinence (SUI) - Urodynamic Early Feasibility Study

Quick Facts

Study Start:2024-02-26

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05900570

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* Predominant urge incontinence per patient report or medical record * 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 * 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 * 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 active neurostimulators, pacemakers, or defibrillators; neurostimulators which are passive or that can be briefly turned off for the stimulation procedure are acceptable * 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

Inclusion Criteria

Exclusion 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

* Predominant urge incontinence per patient report or medical record
* 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
* 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
* 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 active neurostimulators, pacemakers, or defibrillators; neurostimulators which are passive or that can be briefly turned off for the stimulation procedure are acceptable
* 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

Contacts and Locations

Study Contact

Angela Waldvogel, BSN

CONTACT

248-551-2572

Angela.Waldvogel@corewellhealth.org

Jennifer Giordano, BSN

CONTACT

5862424028

jennifer.giordano@corewellhealth.org

Principal Investigator

Kenneth Peters, MD

PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Study Locations (Sites)

Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073

United States

Collaborators and Investigators

Sponsor: William Beaumont Hospitals

Kenneth Peters, MD, PRINCIPAL_INVESTIGATOR, William Beaumont Hospitals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-26

Study Completion Date2025-08

Study Record Updates

Study Start Date2024-02-26

Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

Stress Urinary Incontinence