NCT03995797

Brief Summary

Patients seen with Stage 1-2 pelvic organ prolapse (POP) who have failed conservative treatments will be offered to participate in a sham controlled RCT of outpatient therapy with the Fotona Smooth Erbium Yag Laser. Patients will be randomised to either outpatient laser treatments or sham treatments. Patients will be blinded to which arm they have been randomised. Patients will be asked to complete appropriate relevant symptom and quality of life questionnaires and prolapse scoring, prior to treatment and at each monthly treatment and then 6 and 12 months following the final treatment. At 6 months following final treatment, Sham patients will be un-blinded and offered the laser therapy if they wish.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2023

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
3.5 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

Same day

First QC Date

March 28, 2019

Last Update Submit

September 17, 2025

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

  • Pelvic Organ Prolapse Quantification Score (POP-Q) between baseline and 6 months after treatment.

    The change in Pelvic Organ Prolapse Quantification Score (PoP-Q)classification between baseline and 6 months, range = 0 - stage 4

    6 months

  • Pelvic Organ Prolapse Quantification Score (POP-Q) between baseline and 12 months after treatment.

    The change in Pelvic Organ Prolapse Quantification Score (PoP-Q) classification between baseline and 12 months, range = 0 - stage 4

    12 months

Secondary Outcomes (7)

  • Change in mean International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) test scores from baseline to 6 months post treatment

    6 months

  • Change in mean International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) test scores from baseline to 12 months post treatment

    12 months

  • Patient's Global Impression of Improvement (PGI-I) at 6 months

    6 months

  • Patient's Global Impression of Improvement (PGI-I) at 12 months

    12 months

  • Change in mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) scores

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Treatment arm

ACTIVE COMPARATOR

Treatment with erbium YAG laser

Procedure: Laser therapy

Sham arm

PLACEBO COMPARATOR

Sub therapeutic procedure with erbium YAG laser

Procedure: Laser therapy

Interventions

Laser therapyPROCEDURE

Erbium YAG laser

Sham armTreatment arm

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult Female, 18 years of age or older
  • Clinical diagnosis of symptomatic stage 1-2 pelvic organ prolapse (PoPQ classification)
  • Failed / declined conservative treatments, such as pelvic floor muscle training or vaginal pessaries

You may not qualify if:

  • Pre-existing bladder pathology including prior radiation treatment
  • Pregnancy
  • BMI\>35
  • Radical pelvic surgery or previous incontinence surgery
  • Urinary tract infection or other active infections of urinary tract or bladder
  • Any form of pelvic organ prolapse greater than stage 2, according to POP-Q
  • Diagnosis of collagen disorders eg.benign joint hypermobility / Elhers-Danlos / Marfans etc.
  • Incomplete bladder emptying
  • Vesicovaginal fistula
  • Faecal incontinence
  • Unwillingness or inability to complete follow-up schedule
  • Unwillingness or inability to give Informed Consent
  • Failure to comply with diary requirements during extended baseline period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.

    PMID: 40709601DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2019

First Posted

June 24, 2019

Study Start

January 1, 2023

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share