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Procedure

Nerve Stimulation Therapy for Bladder Pain Syndrome

N/A

Recruiting

Led By Eli Medvescek, MD

Research Sponsored by Walter Reed National Military Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female sex

Age greater than or equal to 18

Must not have

Neurogenic bladder and patients with spinal cord injury

Local infection at injection site

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the initial appointment and at 1-, 3-, and 6-month follow-ups.

Summary

"This trial aims to test whether using electrical micro-current on a group of nerves can improve bladder pain syndrome (BPS) in women. Participants will undergo a procedure involving short bursts of electrical energy directed at

Who is the study for?

This trial is for women over 18 with bladder pain syndrome (BPS), who are eligible for DEERS health care benefits and have a specific score on a BPS diagnostic test. It's not suitable for those who don't meet these criteria.

What is being tested?

The study tests pulsed radiofrequency ablation—a procedure using electrical micro-currents aimed at nerves to relieve BPS symptoms—against sham ablation, which is like a placebo. Participants will be compared after one treatment over six months.

What are the potential side effects?

Potential side effects may include discomfort or minor pain where the needles are inserted during the procedure, possible temporary nerve irritation, and typical risks associated with needle insertion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am female.

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I am 18 years old or older.

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I have been diagnosed with Bladder Pain Syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a neurogenic bladder or a spinal cord injury.

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I have an infection where I get my shots.

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I do not have severe heart or circulation problems.

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I currently have sepsis.

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I have spine issues that prevent certain medical procedures.

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I have an active cancer in my pelvic area or reproductive organs.

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I have a blood clotting disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the initial appointment and at 1-, 3-, and 6-month follow-ups.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the initial appointment and at 1-, 3-, and 6-month follow-ups.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the initial appointment and at 1-, 3-, and 6-month follow-ups. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

VAS Pain Score

Secondary study objectives

Average number of daytime episodes of urinary incontinence over the prior week

Average number of daytime voids over the prior week

Number of treatments currently taking for BPS

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pulsed Radiofrequency Ablation ArmExperimental Treatment1 Intervention

18 total subjects in this arm. Subjects will be laid in the prone position. Local anesthesia will be administered. The appropriate spinal interspace will be identified under fluoroscopic guidance and hollow-tip needles will be inserted through the back into the retroperitoneal space adjacent to the superior hypogastric plexus. A microelectrode will be inserted through the hollow needle. A test pulse will be delivered. When proper positioning has been confirmed, 4mL of 1% lidocaine without epinephrine will be administered to reduce discomfort associated with radiofrequency ablation. Pulsed radiofrequency ablation will be performed at a pulse frequency of 2Hz, pulse width of 20ms, temperature of 42 degrees Celsius, total duration 120 seconds. The microelectrode and hollow-tip needle will then be withdrawn.

Group II: Sham ArmPlacebo Group1 Intervention

18 total subjects in this arm. Subjects will be laid in the prone position. Local anesthesia will be administered. The appropriate spinal interspace will be identified under fluoroscopic guidance and hollow-tip needles will be inserted through the back into the retroperitoneal space adjacent to the superior hypogastric plexus. A microelectrode will be inserted through the hollow needle. A test pulse will be delivered. Sham pulsed radiofrequency ablation will then be performed with the radiofrequency generator disconnected from the microelectrode. The duration of the sham procedure will be 120 seconds. The microelectrode and hollow-tip needle will then be withdrawn.

0 / 10Eligibility criteria met