NCT03996070

Brief Summary

Patients seen with stress urinary incontinence (SUI) that 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 prior to treatment and then at 6 and 12 months following the final treatment. At 6 months Sham patients will be un-blinded and offered the laser therapy if they wish.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 years until next milestone

Study Start

First participant enrolled

June 6, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

March 28, 2019

Last Update Submit

September 17, 2025

Conditions

Female Stress Incontinence

Outcome Measures

Primary Outcomes (1)

  • Assessment of 1hr pad weight test

    The change in standardised 1hr pad weight test from baseline to 6 months following treatment compared with the sham arm.

    6 months

Secondary Outcomes (10)

  • Change in cough stress test from baseline to 6 months post treatment

    6 months

  • Change in cough stress test from baseline to 12 months post treatment

    12 months

  • change in 1-hour pad weight test from baseline to 12 months post treatment

    12 months

  • International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) from baseline to 6 months post treatment

    6 months

  • International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) from baseline to 12 months post treatment

    12 months

  • +5 more secondary outcomes

Study Arms (2)

Treatment arm

ACTIVE COMPARATOR

Therapeutic dose regime

Procedure: Laser therapy

Sham arm

PLACEBO COMPARATOR

Sub-therapeutic dose regime

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 and UDS diagnosis of Stress Urinary Incontinence
  • SUI on 1-hour Pad weight test between 2g and 25g (SUI I: 2-10g, SUI II:11-25g)
  • No significant improvement in urinary incontinence from at least one previous conservative treatment, such as pelvic floor muscle training

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
  • SUI on 1 hour pad weight test \>25g (SUI III: \>25g)
  • Any form of pelvic organ prolapse greater than stage 2, according to POP-Q
  • Diagnosis of urge incontinence
  • 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

Study Sites (1)

Basingstoke & North Hampshire Hospital

Basingstoke, Hampshire, RG24 9NA, United Kingdom

Location

Related Publications (2)

  • Phillips C, Shah G, Gamper M, Kuszka A, Chandrakumaran K, Viereck V. Vaginal Erbium Laser for the Treatment of Mild-to-Moderate Stress Urinary Incontinence: A Multicentre Randomised Sham-Controlled Trial. BJOG. 2025 Nov 12. doi: 10.1111/1471-0528.70080. Online ahead of print.

    PMID: 41221700DERIVED

  • 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

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Christian Phillips

    Hampshire Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

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

June 6, 2022

Primary Completion

November 30, 2024

Study Completion

June 30, 2025

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)