CystoscopyNCT04440579
Utilization of PTNS During Office-Based Cystoscopy
A study testing Percutaneous Tibial Nerve Stimulation (PTNS) and Standard Cystoscopy in people with Cystoscopy, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This study will be a double-blind, randomized control trial, with one additional unblinded arm. This study has been designed to identify a means of improving quality of life for patients requiring in-office cystoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystoscopy
- What is being tested?
- Percutaneous Tibial Nerve Stimulation (PTNS) and Standard Cystoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2020to 26 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older
- Patients undergoing routine office-based cystoscopy by a urology provider
Who cannot join
- Patients for whom ancillary procedures are performed during cystoscopy, including ureteral stent removal, bladder stone removal, biopsy, or fulguration
- Patients undergoing cystoscopy due to concern for urologic injury
- Patients undergoing cystoscopy due to concern for prosthetic abnormality, including erosion or malposition
- Patients who perform clean intermittent catheterization
- Patients with pre-existing neurological pathology, including but not limited to multiple sclerosis, spinal cord injury, Parkinson's disease, or peripheral neuropathy of any etiology
- Patients having undergone prior non-endoscopic prostatectomy (radical prostatectomy, simple prostatectomy)
Show all 9Show fewer
- Patients with a history of interstitial cystitis/chronic pelvic pain
- Patients who have taken an analgesic (excluding 81mg aspirin) in the past 12 hours
- Patients with a history of urethral stricture disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Health System
Kansas City, Kansas, 66160
About this study
Official title: Utilization of Percutaneous Tibial Nerve Stimulation During Office-Based Cystoscopy: A Pilot Study
This study will be a double-blind, randomized control trial, with one additional unblinded arm. This study has been designed to identify a means of improving quality of life for patients requiring in-office cystoscopy. Percutaneous tibial nerve stimulation (PTNS) has been shown to improve quality of life and symptom control in multiple urological conditions based on shared neuroanatomical structures between the genitourinary system and the tibial nerve The goal of this project is to demonstrate the efficacy and safety of PTNS in minimizing patient discomfort during cystoscopy to develop a larger randomized control trial in the near future.
- Conditions
- Cystoscopy
- Being tested
- Percutaneous Tibial Nerve Stimulation (PTNS), Sham Percutaneous Tibial Nerve Stimulation (PTNS), Standard Cystoscopy
- Keywords
- Cystoscopy, Urology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Tibial Nerve Stimulation (PTNS)Procedure or surgery
PTNS is neuromodulation that uses electricity to stimulate the nervous system, specifically the posterior tibial nerve, and is minimally invasive.
Sham Percutaneous Tibial Nerve Stimulation (PTNS)Procedure or surgery
Patients will be connected to the PTNS device but the device will remain off for the entirety of the procedure
Standard CystoscopyProcedure or surgery
Patient will undergo standard cystoscopy
| Study group | Role | What they receive |
|---|---|---|
| Standard Cystoscopy | Active comparator | Patients will undergo a standard of care cystoscopy Receives: Procedure: Standard Cystoscopy |
| PTNS and Cystoscopy | Experimental | Patients will undergo PTNS while undergoing cystoscopy Receives: Procedure: Percutaneous Tibial Nerve Stimulation (PTNS); Procedure: Standard Cystoscopy |
| Sham PTN and Cystoscopy | Sham comparator | Patients will undergo a sham PTNS procedure while undergoing cystoscopy Receives: Procedure: Sham Percutaneous Tibial Nerve Stimulation (PTNS); Procedure: Standard Cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Discomfort
To assess the ability of percutaneous tibial nerve stimulation to improve patient discomfort during routine office-based cystoscopy based on a 10-point visual analogue scale (VAS) by comparing median and interquartile ranges between groups. A score of 0 will indicate no pain whereas a score of 10 indicates the worst pain imaginable.
Measured: One year
Secondary outcomes (1)
Safety of PTNS: adverse events
To determine the safety of PTNS for use in the setting of routine office-based cystoscopy based on rate of adverse events as defined by the Clavien-Dindo classification system
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start7 Aug 2020
- Primary completion18 Sep 2020
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Holzbeierlein, University of Kansas Medical Center
- Investigators
- Jeffrey Holzbeierlein, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440579
- Sponsor's protocol ID
- 145954
- Status last verified
- Oct 2024
- First submitted
- 17 Jun 2020
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Percutaneous Tibial Nerve Stimulation During Office-Based Cystoscopy: A Pilot Study
- ClinicalTrials.gov ID
- NCT04440579
- Acronym / sponsor ID
- 145954
- Conditions
- Cystoscopy
- Keywords
- Cystoscopy, Urology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a double-blind, randomized control trial, with one additional unblinded arm. This study has been designed to identify a means of improving quality of life for patients requiring in-office cystoscopy. Percutaneous tibial nerve stimulation (PTNS) has been shown to improve quality of life and symptom control in multiple urological conditions based on shared neuroanatomical structures between the genitourinary system and the tibial nerve The goal of this project is to demonstrate the efficacy and safety of PTNS in minimizing patient discomfort during cystoscopy to develop a larger randomized control trial in the near future.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Cystoscopy | Active comparator | Procedure: Standard CystoscopyPatients will undergo a standard of care cystoscopy |
| PTNS and Cystoscopy | Experimental | Procedure: Percutaneous Tibial Nerve Stimulation (PTNS), Procedure: Standard CystoscopyPatients will undergo PTNS while undergoing cystoscopy |
| Sham PTN and Cystoscopy | Sham comparator | Procedure: Sham Percutaneous Tibial Nerve Stimulation (PTNS), Procedure: Standard CystoscopyPatients will undergo a sham PTNS procedure while undergoing cystoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years of age or older
- Patients undergoing routine office-based cystoscopy by a urology provider
Key exclusion criteria (9 listed)
- Patients for whom ancillary procedures are performed during cystoscopy, including ureteral stent removal, bladder stone removal, biopsy, or fulguration
- Patients undergoing cystoscopy due to concern for urologic injury
- Patients undergoing cystoscopy due to concern for prosthetic abnormality, including erosion or malposition
- Patients who perform clean intermittent catheterization
- Patients with pre-existing neurological pathology, including but not limited to multiple sclerosis, spinal cord injury, Parkinson's disease, or peripheral neuropathy of any etiology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Tibial Nerve Stimulation (PTNS)PTNS is neuromodulation that uses electricity to stimulate the nervous system, specifically the posterior tibial nerve, and is minimally invasive. | Procedure or surgery | PTNS and Cystoscopy |
| Sham Percutaneous Tibial Nerve Stimulation (PTNS)Patients will be connected to the PTNS device but the device will remain off for the entirety of the procedure | Procedure or surgery | Sham PTN and Cystoscopy |
| Standard CystoscopyPatient will undergo standard cystoscopy | Procedure or surgery | PTNS and Cystoscopy, Sham PTN and Cystoscopy, Standard Cystoscopy |
Primary outcome
Patient Discomfort
Time frame: One year
To assess the ability of percutaneous tibial nerve stimulation to improve patient discomfort during routine office-based cystoscopy based on a 10-point visual analogue scale (VAS) by comparing median and interquartile ranges between groups. A score of 0 will indicate no pain whereas a score of 10 indicates the worst pain imaginable.
1 secondary outcome
Safety of PTNS: adverse events
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Holzbeierlein, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Tibial Nerve Stimulation (PTNS) and Standard Cystoscopy in people with Cystoscopy, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Discomfort (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024; AzTrials last refreshed its copy on 29 Oct 2026.