CPT Testing for Sacral Neuromodulation Outcomes

NCT00617786 | Completed

• 1 other identifier: 2007-176
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study. Subjects will be recruited from the urology practices of Dr. Ken Peters and Dr. Ananias Diokno at William Beaumont Hospital. Subjects will be referred to the study by the clinician recommending Sacral NeuroModulation therapy (SNM). This pilot study is to explore the effect of SNM on sensory pathways by measuring CPT values pre and post SNM treatment.

Conditions

Incontinence

Keywords

urinary urgency; urinary frequency; urge incontinence; sacral neuromodulation therapy; urgency; frequency

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the change in CPT measurement after placement of SNM therapy as compared to baseline CPT measurements.

  visit 1

Interventions

Current Perception Threshold (CPT) Testing PROCEDURE

During the CPT testing a catheter will be placed in the bladder. The catheter has sensors to record the body's sensation of pressure. The sensation felt will be similar to a light touch and is painless. A gel pad will be placed in the general area of the vagina to record the feeling of a light touch.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established diagnosed overactive bladder
• Scheduled to receive SMN therapy by Dr. Peters or Dr. Diokno
• Women at least 18 years of age
• Capable of giving informed consent
• Capable and willing to follow all study related procedures (e.g. bladder and urethral catheterization, answering questions during CPT testing, complete questionnaires regarding pertinent medical history).

You may not qualify if:

• Current Urinary tract infection
• Currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function.
• Pregnancy or intending to become pregnant during the study
• Cannot independently comprehend and complete relevant medical history questionnaires.
• The subject is deemed unsuitable for enrollment in this study by the investigators based on their history.
• Men are excluded
• TENS, PTNS or acupuncture therapy currently being used for symptoms

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth Peters, M.D.

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: February 18, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 23, 2011

Record last verified: 2011-11

Locations

US (1)