PTNS Versus Sham Efficacy in Treatment of BPS

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02747420
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 45
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This is a prospective, single center, double-blind, randomized, controlled trial comparing the efficacy of percutaneous tibial nerve stimulation to sham in the treatment of Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC) through 12 weeks of therapy.

Condition or Disease	Intervention/Treatment	Phase
Interstitial Cystitis Bladder Pain Syndromes	Device: NURO TM; Device: Sham	N/A

Detailed Description

This is a pilot study to evaluate the efficacy of the systematic effects of posterior tibial nerve stimulation (PTNS) treatment compared to an inactive sham intervention in female subjects with interstitial cystitis/bladder pain syndrome (IC/BPS) in an intent-to-treat analysis. The primary outcome measure will be the Patient Global Impression of Improvement (PGI-I) a single item questionnaire assessing overall impression of improvement over time at the initial 12 weeks endpoint.

It is hypothesized that subjects randomized to the PTNS arm will demonstrate a greater improvement in both pain and quality of life scores, when compared with subjects who are randomized to the sham arm.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of PTNS Versus Sham Efficacy in Treatment of Bladder Pain Syndrome
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Jan 18, 2019
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Post Tibial Nerve Stimulation Group (PTNS)	Device: NURO TM; The lower extremity will be palpated and a needle insertion site will be identified 5 cm from the medial malleolus and posterior to the tibia. Between the posterior margin of the tibia and the soleus muscle, a 34-gauge acupuncture-like needle will be inserted 3-4 cm to the tibial nerve. A grounding pad will be placed on the bottom of the foot just below the smallest toe. An inactive grounding pad will be placed on top of the foot above the small toe to be consistent with the sham pad placement. The needle and grounding pad will be connected to the stimulator and the stimulation will be increased from 0 to 10 Milli-ampere. The needle will be taped. The electrical current will be set by the subject and the mA will be recorded. A 30 minute stimulation session will be given at 20 Hz.; Other Names: Neuromodulation system, Medtronic Device Model # 3533 stimulator model NURO 100
Sham Comparator: Sham Group	Device: Sham; A needle will be inserted into the lower extremity approximately 5 cm cephalad from the medial malleolus and posterior to the tibia. A sham needle will be used a the tibial nerve insertion site. This will stimulate needle placement without puncturing the skin. The needle will be taped in place. The "grounding pad" from the transcutaneous electrical nerve stimulation (TENS) unit device will be placed on the bottom of the foot below the smallest toe. Another electrode will be placed on the top of the foot above the small toe for conduction. The TENS electrode will be connected to the TENS unit, at 20 Hz (the same as the PTNS group). The unit will be turned on and the stimulation will be increased to the subject's first sensory level. The subject will sense stimulation to either the bottom of the foot or the toe. the TENS unit will be on for a 30 minute test period. The TENS unit will be removed and the needle will be discarded.

Outcome Measures

Primary Outcome Measures

1. Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2 [12 weeks]

   A single item questionnaire assessing overall impression of improvement over time at the initial 12 weeks endpoint. Patients are asked to describe their condition compared to how it was before intervention on a scale from 1 to 7: Very much better = 1 Much better = 2 A little better = 3 No change = 4 A little worse = 5 Much worse = 6 Very much worse = 7

Secondary Outcome Measures

1. Visual Analog Scale (VAS) [12 Weeks]

   Quality of Life Scores

2. O'Leary-Sant Pain Scores [12 weeks]

   pain intensity, location of pain and associated symptoms

3. Over Active Bladder-Questionnaire (OAB-Q) [12 Weeks]

   This will allow for evaluation of subjects with concomitant overactive bladder and painful bladder syndrome characteristics.

4. The SF-12 (Short Form) Health Scale [12 Weeks]

   Used to evaluate quality of life of each subject at the three analysis intervals.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Women ≥18 years old with visual analog scale > 5

• Cessation of all analgesics or other medication for pain for at least 2 weeks prior to the PTNS intervention

• Discontinuation of any other electrical stimulation methods for 3 months prior to PTNS intervention.

• Capable of giving informed consent

• Ambulatory

• Capable and willing to follow all study-relation procedures

Exclusion Criteria:

• Patients pregnant or planning to become pregnant during the study duration

• Botox use in pelvic floor muscles within the last year

• Current urinary or vaginal infections

• Current use of Interstim device

• History of a cardiac pacemaker

• Diagnosis of neuropathy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Benjamin Brucker, MD, NYU Langone Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 18, 2016

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02747420
• Other Study ID Numbers: 15-01447
• First Posted: Apr 21, 2016
• Last Update Posted: Jan 26, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by NYU Langone Health: Posterior Tibial Nerve Stimulation, Bladder
• Additional relevant MeSH terms: Cystitis; Cystitis, Interstitial; Syndrome

Study Results

Participant Flow

Arm/Group Title	Post Tibial Nerve Stimulation Group (PTNS)	Sham Group
Arm/Group Description	NURO TM: The lower extremity will be palpated and a needle insertion site will be identified 5 cm from the medial malleolus and posterior to the tibia. Between the posterior margin of the tibia and the soleus muscle, a 34-gauge acupuncture-like needle will be inserted 3-4 cm to the tibial nerve. A grounding pad will be placed on the bottom of the foot just below the smallest toe. An inactive grounding pad will be placed on top of the foot above the small toe to be consistent with the sham pad placement. The needle and grounding pad will be connected to the stimulator and the stimulation will be increased from 0 to 10 Milli-ampere. The needle will be taped. The electrical current will be set by the subject and the mA will be recorded. A 30 minute stimulation session will be given at 20 Hz.	Sham: A needle will be inserted into the lower extremity approximately 5 cm cephalad from the medial malleolus and posterior to the tibia. A sham needle will be used a the tibial nerve insertion site. This will stimulate needle placement without puncturing the skin. The needle will be taped in place. The "grounding pad" from the transcutaneous electrical nerve stimulation (TENS) unit device will be placed on the bottom of the foot below the smallest toe. Another electrode will be placed on the top of the foot above the small toe for conduction. The TENS electrode will be connected to the TENS unit, at 20 Hz (the same as the PTNS group). The unit will be turned on and the stimulation will be increased to the subject's first sensory level. The subject will sense stimulation to either the bottom of the foot or the toe. the TENS unit will be on for a 30 minute test period. The TENS unit will be removed and the needle will be discarded.
Period Title: Overall Study
STARTED	18	22
COMPLETED	11	18
NOT COMPLETED	7	4

Baseline Characteristics

Arm/Group Title	Post Tibial Nerve Stimulation Group (PTNS)	Sham Group	Total
Arm/Group Description	NURO TM: The lower extremity will be palpated and a needle insertion site will be identified 5 cm from the medial malleolus and posterior to the tibia. Between the posterior margin of the tibia and the soleus muscle, a 34-gauge acupuncture-like needle will be inserted 3-4 cm to the tibial nerve. A grounding pad will be placed on the bottom of the foot just below the smallest toe. An inactive grounding pad will be placed on top of the foot above the small toe to be consistent with the sham pad placement. The needle and grounding pad will be connected to the stimulator and the stimulation will be increased from 0 to 10 Milli-ampere. The needle will be taped. The electrical current will be set by the subject and the mA will be recorded. A 30 minute stimulation session will be given at 20 Hz.	Sham: A needle will be inserted into the lower extremity approximately 5 cm cephalad from the medial malleolus and posterior to the tibia. A sham needle will be used a the tibial nerve insertion site. This will stimulate needle placement without puncturing the skin. The needle will be taped in place. The "grounding pad" from the transcutaneous electrical nerve stimulation (TENS) unit device will be placed on the bottom of the foot below the smallest toe. Another electrode will be placed on the top of the foot above the small toe for conduction. The TENS electrode will be connected to the TENS unit, at 20 Hz (the same as the PTNS group). The unit will be turned on and the stimulation will be increased to the subject's first sensory level. The subject will sense stimulation to either the bottom of the foot or the toe. the TENS unit will be on for a 30 minute test period. The TENS unit will be removed and the needle will be discarded.	Total of all reporting groups
Overall Participants	18	22	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.7 (18.3)	51.7 (18.2)	51.2 (18.3)
Sex: Female, Male (Count of Participants)
Female	18 100%	22 100%	40 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 16.7%	2 9.1%	5 12.5%
Not Hispanic or Latino	15 83.3%	20 90.9%	35 87.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	14 77.8%	17 77.3%	31 77.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	4 22.2%	5 22.7%	9 22.5%
Region of Enrollment (participants) [Number]
United States	18 100%	22 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2
Description	A single item questionnaire assessing overall impression of improvement over time at the initial 12 weeks endpoint. Patients are asked to describe their condition compared to how it was before intervention on a scale from 1 to 7: Very much better = 1 Much better = 2 A little better = 3 No change = 4 A little worse = 5 Much worse = 6 Very much worse = 7
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Post Tibial Nerve Stimulation Group (PTNS)	Sham Group
Arm/Group Description	NURO TM: The lower extremity will be palpated and a needle insertion site will be identified 5 cm from the medial malleolus and posterior to the tibia. Between the posterior margin of the tibia and the soleus muscle, a 34-gauge acupuncture-like needle will be inserted 3-4 cm to the tibial nerve. A grounding pad will be placed on the bottom of the foot just below the smallest toe. An inactive grounding pad will be placed on top of the foot above the small toe to be consistent with the sham pad placement. The needle and grounding pad will be connected to the stimulator and the stimulation will be increased from 0 to 10 Milli-ampere. The needle will be taped. The electrical current will be set by the subject and the mA will be recorded. A 30 minute stimulation session will be given at 20 Hz.	Sham: A needle will be inserted into the lower extremity approximately 5 cm cephalad from the medial malleolus and posterior to the tibia. A sham needle will be used a the tibial nerve insertion site. This will stimulate needle placement without puncturing the skin. The needle will be taped in place. The "grounding pad" from the transcutaneous electrical nerve stimulation (TENS) unit device will be placed on the bottom of the foot below the smallest toe. Another electrode will be placed on the top of the foot above the small toe for conduction. The TENS electrode will be connected to the TENS unit, at 20 Hz (the same as the PTNS group). The unit will be turned on and the stimulation will be increased to the subject's first sensory level. The subject will sense stimulation to either the bottom of the foot or the toe. the TENS unit will be on for a 30 minute test period. The TENS unit will be removed and the needle will be discarded.
Measure Participants	18	22
Count of Participants [Participants]	2 11.1%	4 18.2%

2. Secondary Outcome

Title	Visual Analog Scale (VAS)
Description	Quality of Life Scores
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	O'Leary-Sant Pain Scores
Description	pain intensity, location of pain and associated symptoms
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Over Active Bladder-Questionnaire (OAB-Q)
Description	This will allow for evaluation of subjects with concomitant overactive bladder and painful bladder syndrome characteristics.
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	The SF-12 (Short Form) Health Scale
Description	Used to evaluate quality of life of each subject at the three analysis intervals.
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Post Tibial Nerve Stimulation Group (PTNS)		Sham Group
Arm/Group Description	NURO TM: The lower extremity will be palpated and a needle insertion site will be identified 5 cm from the medial malleolus and posterior to the tibia. Between the posterior margin of the tibia and the soleus muscle, a 34-gauge acupuncture-like needle will be inserted 3-4 cm to the tibial nerve. A grounding pad will be placed on the bottom of the foot just below the smallest toe. An inactive grounding pad will be placed on top of the foot above the small toe to be consistent with the sham pad placement. The needle and grounding pad will be connected to the stimulator and the stimulation will be increased from 0 to 10 Milli-ampere. The needle will be taped. The electrical current will be set by the subject and the mA will be recorded. A 30 minute stimulation session will be given at 20 Hz.		Sham: A needle will be inserted into the lower extremity approximately 5 cm cephalad from the medial malleolus and posterior to the tibia. A sham needle will be used a the tibial nerve insertion site. This will stimulate needle placement without puncturing the skin. The needle will be taped in place. The "grounding pad" from the transcutaneous electrical nerve stimulation (TENS) unit device will be placed on the bottom of the foot below the smallest toe. Another electrode will be placed on the top of the foot above the small toe for conduction. The TENS electrode will be connected to the TENS unit, at 20 Hz (the same as the PTNS group). The unit will be turned on and the stimulation will be increased to the subject's first sensory level. The subject will sense stimulation to either the bottom of the foot or the toe. the TENS unit will be on for a 30 minute test period. The TENS unit will be removed and the needle will be discarded.
All Cause Mortality
	Post Tibial Nerve Stimulation Group (PTNS)		Sham Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/22 (0%)
Serious Adverse Events
	Post Tibial Nerve Stimulation Group (PTNS)		Sham Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Post Tibial Nerve Stimulation Group (PTNS)		Sham Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.