Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04236596
Other study ID # HUM00165005
Secondary ID OT2OD028191
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2020
Est. completion date June 8, 2023

Study information

Verified date December 2023
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is to map the pudendal nerve. In this study the researchers will examine subjects who are already receiving an implanted stimulator at their pudendal nerve as part of their normal clinical care.


Description:

The pudendal nerve goes to the urethra, anus, and other areas of the pelvic floor. Electrical stimulation of this nerve can help with bladder problems and pelvic pain. Researchers do not understand how the nerve anatomy is different between people. Successfully mapping the pudendal nerve may help improve the medical care for future patients with bladder problems, pelvic pain, bowel problems, and sexual problems.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date June 8, 2023
Est. primary completion date June 8, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Clinically referred as having bladder problems that have not responded to conservative treatment. Normal clinical care includes referral to implant of Medtronic Interstim neurostimulator at the pudendal nerve. Fully eligible to receive an Interstim implant. - Adult (18 or older), capable of providing own informed consent and communicating clearly with research team - Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English - Capable of attending all experimental sessions (Visit 1: pre-stage-1 imaging, Visit 2: stage-1 surgery, Visit 3: CT after stage-2 surgery, Visit 3: cystometrogram test) Exclusion - Implanted materials that prohibit magnetic imaging - Any medical problems that prevent an individual from laying flat in an MRI or CT scanner, are are claustrophobic. - Areflexive or atonic bladder - Pregnant or planning to become pregnant. If a woman of child-bearing potential wishes to participate in this study, they will be pre-screened with a test to detect pregnancy. - Diagnosed neurogenic bladder, pudendal nerve damage, lower motor dysfunction, or other conditions that would affect the neural circuits involved in micturition. - Unwilling to allow de-identified data to be stored for future use or shared with other researchers.

Study Design


Intervention

Device:
Medtronic Interstim II Model 3058 Neurostimulator
All stimulation parameters used will be within the normal hard-coded limits of the implantable pulse generator (IPG).

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evoked bladder contractions of at least 20 centimeters of water (cmH2O) during the stage-4 test At least 50% of participants Visit 4, approximately 10 weeks after consent
Secondary Selectivity index for selective stimulation of pudendal nerve branches for patient stimulation Selectivity Index (SI) will be calculated for each sensor recording from distal pudendal nerve branches. This includes sensors in the proximal urethra (proximal perineal branch - PPB), distal urethra (distal perineal branch - DPB), and anal electromyography (EMG) (ischeal rectal nerve - IRN).
The SI calculation may be modified in some patients, as necessary, for factors such as the presence of a short urethra that only allows for a single intraurethral pressure measure (female urethras < male urethras) and/or the placement of EMG in the perineal floor between yields one or more additional sensors.
Visit 2: Stage-1 (approximately 3 weeks after consent)
Secondary Selectivity index for selective stimulation of pudendal nerve branches for simulated model stimulation Selectivity Index (SI) will be calculated for each sensor recording from distal pudendal nerve branches. This includes sensors in the proximal urethra (proximal perineal branch - PPB), distal urethra (distal perineal branch - DPB), and anal EMG (ischeal rectal nerve - IRN).
The SI calculation may be modified in some patients, as necessary, for factors such as the presence of a short urethra that only allows for a single intraurethral pressure measure (female urethras < male urethras) and/or the placement of EMG in the perineal floor between yields one or more additional sensors.
Visit 2: Stage-1 (approximately 3 weeks after consent)
See also
  Status Clinical Trial Phase
Withdrawn NCT05538273 - Optimal Management of Urinary Catheter in Gyn Onc
Recruiting NCT05065255 - Study of the Criteria for Choosing Speedicath Catheters During the Initiation of Self-catheterization
Completed NCT05526651 - Improvement of Urinary Retention Symptoms With Electroacupuncture Therapy N/A
Not yet recruiting NCT06070545 - The Effect of Modified Supine Position on Urinary Elimination After Percutaneous Coronary Intervention N/A
Recruiting NCT03314025 - Prophylactic Tamsulosin in Prevention of Post-operative Urinary Retention in Men After Transanal Endoscopic Microsurgery Phase 2
Recruiting NCT05439902 - Efficacy of Alpha-blockers (Tamsulosin) in the Treatment of Symptomatic Dysuria in Multiple Sclerosis in Women N/A
Enrolling by invitation NCT05259800 - Peppermint Oil for Urinary Retention N/A
Recruiting NCT06417346 - Comparison of Laparoscopic and Open Inguinal Hernia Repair in Elderly Patients N/A
Completed NCT03296280 - Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program
Completed NCT04715971 - Urinary Retention on an Acute Geriatric Hospitalisation Unit.
Completed NCT03302936 - Assessing Pyridium for Post-Sling Urinary Retention Phase 4
Completed NCT02886143 - Effect of Active vs. Passive Voiding Trials on Time to Discharge, Urinary Tract Infection, and Urinary Retention Phase 3
Completed NCT02749188 - Evaluation of Bladder Stimulation as a Noninvasive Technique of Urine Collection in Infant Who Have Not Acquired Walking N/A
Completed NCT01284361 - Comparison of Two Intermittent Urinary Catheters N/A
Completed NCT01220362 - Effects of Thoracic Epidural Analgesia and Surgery on Lower Urinary Tract Function: A Randomized, Controlled Study N/A
Terminated NCT00804557 - Efficacy And Safety Of The Uro-Ease® Urinary Catheter During Clean Intermittent Catheterization N/A
Terminated NCT00563654 - Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up N/A
Terminated NCT00563485 - Randomized Trial Comparing Terazosin 5 mg Daily and Doxazosin GITS 4 mg Daily for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up N/A
Terminated NCT04682366 - The Effect of Tamsulosin on Postoperative Urinary Retention Phase 4
Terminated NCT03843073 - Connected Catheter- Safety and Effectiveness Study N/A