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Bladder gel shows promise for chronic pelvic pain in women

NCT ID NCT05544695

Symptom relief Sponsor: MEDA Pharma GmbH & Co. KG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a gel called Cystistat (sodium hyaluronate) placed directly into the bladder to treat women with interstitial cystitis, a condition causing long-term bladder pain. Researchers tracked 74 women to see if the gel improved their symptoms and was safe. The goal was to confirm the gel's benefit-risk balance in real-world use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sodium hyaluronate (Cystistat) bladder instillation
What this could lead to
If results are positive, this could confirm that Cystistat is a safe and effective option for easing bladder pain and discomfort in women with interstitial cystitis.
What could go wrong
This is a small, completed observational study without a placebo group, so results may not prove the treatment works better than no treatment or other options.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

74 people

The number who actually took part.

Started

Oct 2022

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Approximately 74 female patients with IC/BPS will be included in the study

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * First prescription of Cystistat according to instructions for use. * Female patients of any ethnic origin with clinical diagnosis of interstitial cystitis (IC)/bladder pain syndrome (BPS). If in accordance with routine clinical practice at the site, ESSIC diagnostic criteria will be used. * Age: 18 years and older. * At least 6 months duration of bladder pain/discomfort symptom(s), e.g. constant bladder pain/discomfort or bladder pain/discomfort when voiding or as a burning sensation between voids as the bladder fills with urine. * At least one accompanying intermittent or persistent lower urinary tract symptom, such as urinary frequency, urgency, or nocturia during the previous 6 months. * Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) \> 18 prior to first treatment. * Written informed consent. Exclusion Criteria: * Known hypersensitivity reactions to sodium hyaluronate. * Pregnancy / planned pregnancy or breastfeeding during the course of this NIS. * Known history of any GAG substitution therapy within the last 2 years. * Known history of fulguration or resection of Hunner's lesions. * Known diagnosis of recurrent urinary tract infection or overactive bladder. * Any other conditions or diseases that can cause similar symptoms, using information from medical history, physical examination findings, laboratory studies (e.g., urine bacterial culture), and other previously performed procedures (e.g., urodynamics, cystoscopy, laparoscopy, radiological studies). * Patients are not able to fulfil study requirements according to physician's opinion.

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Conditions

The condition(s) this trial relates to.

interstitial cystitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Interstitial cystitis and bladder pain syndrome

Contacts and locations

Locations

  • Medical University of Vienna

    Vienna, Austria

More trials for these conditions

Other studies related to the condition(s) this trial covers.