Optilume BPH drug-coated balloon

Optilume BPH uses a balloon passed through the urethra to split the enlarged prostate open along its front. The balloon is coated with a medicine that helps the channel stay open as it heals.

Also called Optilume, Optilume BPH, Optilume BPH catheter system, drug-coated balloon for prostate, paclitaxel balloon prostate, balloon dilation of the prostate, prostate balloon procedure, stretch my prostate open

Where
Outpatient surgery center, hospital operating room, or clinic procedure room
Anesthesia
Sedation or general anesthesia; some centers use local numbing
Time in the room
About 30 to 45 minutes
Hospital stay
Same day
Going home with
Usually a catheter for a few days
Back to normal
About 1 to 2 weeks
Back to work
Often within a few days
See the steps
BladderProstateUrethraBladder neck
Where it happens. The highlighted part is what this procedure treats.

Overview

In BPH (benign prostatic hyperplasia), the side lobes of the prostate press the urethra closed. Optilume BPH opens the channel with a balloon. First, an uncoated balloon is inflated inside the prostate. It stretches the prostate until the two side lobes separate along the front, where they meet, a split called a commissurotomy. Then a second balloon, coated with a medicine called paclitaxel, is inflated in the same place for several minutes.

Paclitaxel slows the growth of scar-forming cells. The idea is that it helps the split heal in its open position instead of closing back up. Nothing is cut away or heated.

The U.S. Food and Drug Administration approved Optilume BPH in 2023 for prostates about 20 to 80 grams. In the PINNACLE randomized trial, men improved more than those who had a sham procedure, and erections and ejaculation were generally preserved. It is newer than other options, so there is less long-term data.

The parts of your body involved

The prostate sits below the bladder and wraps around the urethra. In BPH, the two side lobes grow inward and press together. At the front of the prostate, the lobes meet along a thin line with little tissue. The balloon separates the lobes along this line.

  • Side lobes

    The overgrown prostate tissue that is pushed apart.

  • Anterior commissure

    The front seam where the lobes meet and where the split happens.

  • Bladder neck

    The bladder's outlet, at the top of the prostate.

  • Verumontanum

    A small bump marking where semen enters; the balloon is placed above it to protect ejaculation and continence.

Why it’s done

Optilume BPH is for men with bothersome BPH symptoms who want a short procedure without cutting or heat and who want to protect sexual function.

  • Symptoms despite medicines

    Pills are not helping enough or cause side effects.

  • Protecting sexual function

    Erections and ejaculation were generally preserved in studies.

  • No permanent implant

    Nothing is left behind except a small amount of medicine that fades.

  • Quick procedure

    About half an hour, home the same day.

Other options

  • Watching and waiting or medicines

    Lifestyle changes or medicines such as tamsulosin, finasteride, or tadalafil.

  • UroLift

    Implants hold the lobes apart, often without a catheter.

  • Rezum

    Steam shrinks prostate tissue over weeks; can treat a middle lobe.

  • iTind

    A temporary device reshapes the channel over a week.

  • TURP or HoLEP

    Removing tissue gives larger, longer-proven improvement, but usually dry orgasms.

Getting ready

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Weeks before

The week before

The day of

In the operating room, step by step

Press play or pick a step. Each drawing shows what your surgeon is doing at that moment. Your team may do some steps differently.

Leg supportsAnesthesia teamSurgeon
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1. Anesthesia and positioning

You are sedated or put to sleep, and your legs are placed in padded supports.

  1. You are sedated or put to sleep, and your legs are placed in padded supports.

  2. A scope is passed into the bladder. The urologist looks at the prostate and measures its length from the bladder neck to the verumontanum to pick the right balloon size.

  3. The lobes press together like closed curtains.

  4. An uncoated balloon is placed across the prostate and inflated. It stretches the channel until the lobes split apart along the front seam.

  5. The coated balloon is placed in the same spot and inflated for several minutes. During this time, the medicine passes into the stretched tissue.

    More detail

    The balloon is shaped to sit at the bladder neck and stay in position while inflated. It is kept above the verumontanum to protect the continence muscle and ejaculation.

  6. When the balloon is removed, the channel is visibly wider, with the split at the front.

  7. A catheter is usually placed to drain urine for a few days while the area settles.

After the operation

Right afterward

  • Recovery

    You rest until the anesthesia wears off.

  • Catheter teaching

    A nurse shows you how to manage the catheter and bags.

  • Medicines

    You may get medicine for pain, bladder spasms, and infection.

  • Going home

    Usually the same day, with a driver.

At home

  • Catheter

    The catheter usually stays for a few days. Keep the bag below your bladder.

  • Blood in the urine

    Common for a week or two.

  • Burning and urgency

    Common after the catheter comes out and usually fades in a couple of weeks.

  • Drinking

    Drink plenty of water and limit caffeine and alcohol.

  • Activity

    Light activity right away. Avoid heavy lifting for about a week or as advised.

  • Sex

    Ask your team when to resume and whether to use a condom for a period of time because of the medicine on the balloon.

Recovery timeline

  1. Day 0
    Procedure

    Home the same day with a catheter.

  2. Days 2 to 5
    Catheter out

    Usually removed at a clinic visit.

  3. Weeks 1 to 2
    Healing

    Burning, urgency, and some blood fade.

  4. 2 to 4 weeks
    Flow improving

    Many men notice a stronger stream.

  5. 3 months
    Follow-up

    Symptoms, flow, and emptying are checked.

  6. Long term
    Durability

    Studies so far show improvement lasting several years in most men.

What it feels like

Most men sleep or doze through the procedure. The catheter days and the burning afterward are what they remember.

  1. Waking up

    A strong urge to urinate and awareness of the catheter.

    What helpsSpasm medicine and reassurance from the nurse.

  2. Catheter days

    Self-conscious and uncomfortable at times.

    What helpsA leg bag under loose pants. It is only a few days.

  3. After removal

    Burning and urgency, then an easier stream.

    What helpsDrink steadily and avoid caffeine.

  4. Intimacy

    Relief that erections and ejaculation usually stay the same.

    What helpsAsk about any precautions with sex in the first weeks.

  5. A few months later

    Fewer night trips and less straining.

    What helpsKeep your follow-up visit.

How well it works

In the PINNACLE trial, men who had Optilume BPH improved more than those who had a sham procedure, and most kept their improvement through follow-up.

  • Symptoms and flow

    Symptom scores and flow rates improved, with results kept over the first few years in early studies.

  • Sexual function

    Erections and ejaculation were generally preserved.

  • Longer-term data

    Because it is newer, there is less long-term data than for TURP, HoLEP, UroLift, or Rezum.

  • Later options

    Other treatments can still be done later if needed.

Risks

Every operation has risks. These are the ones people ask about most, with honest odds where good numbers exist. Your surgeon’s own results matter more than averages.

Common

Blood in the urine

Usually mild and short-lived.

Burning and urgency

Usually fades within a couple of weeks.

Catheter for a few days

Needed by most men.

Less common

Urine infection

Treated with antibiotics.

Not able to urinate after the catheter comes out

May need a catheter for a few more days.

Not enough improvement

Some men need another treatment later.

Rare

Significant bleeding

Rarely needs a longer catheter time or another procedure.

Leakage

Rare, because the balloon is kept above the continence muscle.

Call your care team or go to the emergency room if

  • Fever of 101°F (38.3°C) or higher, or shaking chills
  • No urine draining from your catheter for 1 hour
  • Not able to urinate for 6 hours after the catheter comes out
  • Thick red urine or clots that block the flow
  • Severe pain not helped by your medicines

Questions to ask your surgeon

  1. Is my prostate the right size and shape for Optilume BPH?
  2. Will I be asleep, sedated, or awake?
  3. How long will I have a catheter?
  4. How does this compare with UroLift, Rezum, or TURP for someone like me?
  5. Are there precautions with sex or fathering a child because of the medicine on the balloon?
  6. How many Optilume procedures have you done?
  7. What happens if it does not work well enough?
  8. How long do results last, based on the data so far?

Words you may hear

Drug-coated balloon
A balloon covered with medicine that passes into tissue when it is inflated.
Paclitaxel
A medicine that slows the growth of scar-forming cells.
Commissurotomy
Splitting the prostate lobes apart along the seam where they meet.
Anterior commissure
The front seam where the two side lobes meet.
Verumontanum
A small bump in the urethra that marks the continence muscle and where semen enters.
BPH
Benign prostatic hyperplasia: non-cancer growth of the prostate.
Catheter
A soft tube that drains urine from the bladder.
Sham procedure
A pretend procedure used in trials to compare against the real one.

Common questions

Is anything left behind?

No implant is left. A small amount of medicine stays in the tissue and fades over time.

Will I need a catheter?

Usually yes, for a few days.

Does it affect sex?

In studies, erections and ejaculation were generally preserved. Ask about any precautions in the first weeks.

Is it new?

It was approved in the U.S. in 2023, so it has less long-term data than older treatments.

Can I have other treatments later?

Yes. Other procedures remain possible.

Sources this page draws on

  • U.S. Food and Drug Administration, Optilume BPH Catheter System approval (2023)
  • PINNACLE study investigators, PINNACLE randomized sham-controlled trial of the Optilume BPH drug-coated balloon
  • American Urological Association, Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (BPH): AUA Guideline
  • Urology Care Foundation, Benign Prostatic Hyperplasia (BPH)

Written November 2026. This page explains what usually happens. It is not medical advice and does not replace a conversation with your own surgeon, whose plan for you comes first.