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Pelvic organ prolapse laser trial pulled before enrolling anyone

NCT ID NCT03995797

Symptom relief Sponsor: Hampshire Hospitals NHS Foundation Trust 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study planned to test whether a special laser could help women with mild to moderate pelvic organ prolapse who had not gotten relief from other treatments. It was designed as a sham-controlled trial, meaning some women would get the real laser and others a fake procedure, to see if the laser actually worked. However, the trial was withdrawn before any participants were enrolled, so no results are available.

What this could mean

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

Active substance
Erbium YAG laser

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Started

Jan 2023

Finished

Jan 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

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 1. Adult Female, 18 years of age or older 2. Clinical diagnosis of symptomatic stage 1-2 pelvic organ prolapse (PoPQ classification) 3. Failed / declined conservative treatments, such as pelvic floor muscle training or vaginal pessaries Exclusion Criteria: Exclusion Criteria 1. Pre-existing bladder pathology including prior radiation treatment 2. Pregnancy 3. BMI\>35 4. Radical pelvic surgery or previous incontinence surgery 5. Urinary tract infection or other active infections of urinary tract or bladder 6. Any form of pelvic organ prolapse greater than stage 2, according to POP-Q 7. Diagnosis of collagen disorders eg.benign joint hypermobility / Elhers-Danlos / Marfans etc. 8. Incomplete bladder emptying 9. Vesicovaginal fistula 10. Faecal incontinence 11. Unwillingness or inability to complete follow-up schedule 12. Unwillingness or inability to give Informed Consent 13. Failure to comply with diary requirements during extended baseline period

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Conditions

The condition(s) this trial relates to.

pelvic organ prolapse

As listed by the trial registrant

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

Pelvic organ prolapse

More trials for these conditions

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