FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women (UPS-IUL)

October 3, 2023 updated by: Prof. Dr. Volker Viereck

Monocentric, Prospective Pilot Study to Test the Efficacy and Safety of the FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women

Urethral pain syndrome (UPS) is defined by the occurrence of persistent or recurrent episodic urethral pain in the absence of proven infection or other obvious pathology. The objective of this study is to determine the effect of an intraurethral and vaginal laser therapy for the treatment of UPS. The hypothesis is that a significant reduction of urethral pressure pain can be achieved.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Urethral pain syndrome (UPS) is characterized by recurrent or persistent symptoms such as urethral or pelvic pain, daytime frequency and nocturia with unclear aetiology are diagnosed as UPS. Chronic infection by fastidious bacteria leading to chronic inflammation and pain may also cause UPS. Due to the unclear aetiology, the optimal treatment is challenging. It is therefore essential to find new and effective treatment options for patients suffering from UPS. Over the last few years, the use of lasers has become more popular to treat gynaecological and urogynecological conditions including stress urinary incontinence (SUI), genitourinary syndrome of menopause (GSM), vaginal prolapse and other conditions. In several trials, vaginal laser therapy has been shown to have a very good effect on SUI and GSM. Very few publications are available on the use of intraurethral laser therapy for the treatment of SUI and GSM with promising results. This is the first study to test the effect of intraurethral and vaginal laser therapy for the treatment of UPS. The hypothesis is that symptoms can be relieved in patients with UPS i.e. a reduction of urethral pressure pain upon palpation can be achieved.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult female, 18 years of age or older
  • Urethral pressure pain upon palpation, VAS Score ≥ 2
  • Intermittent or chronic pain in the urethra and/or the small pelvis (independent of micturition) for at least 6 months
  • No significant improvement of UPS from at least one previous conservative treatment (pessary, antibiotics, local oestrogens etc.)
  • Signed informed consent

Exclusion Criteria:

  • Pregnancy
  • Treatment with Isotretinoin (Acne, Rosacea) within last 6 months
  • Acute urinary tract infection or other acute infection of the bladder, vagina, vulva or urinary tract detected by routine urine analysis
  • Positive urethral swab for Ureaplasma, Mycoplasma or Chlamydia ≤ 6 weeks. Exception: Patients with chronic and persistent fastidious bacteria can be included six weeks after two unsuccessful treatments with antibiotics. Antibiotics therapy must also include sexual partners.
  • Pre-existing bladder or urethra pathology
  • Interstitial Cystitis
  • Endometriosis
  • Diagnosis of collagen disorders, e.g. benign joint hypermobility / Elhers-Danlos / Marfans etc.
  • Vesicovaginal fistula
  • Unwillingness or inability to complete follow-up schedule
  • Unwillingness or inability to give informed consent
  • Unwillingness or inability to complete questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser
Intraurethral and vaginal laser treatment
Device: Laser
Intraurethral and vaginal laser treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients showing improvement in symptoms due to laser treatment
Time Frame: 5 months
Reduction of urethral pressure pain upon palpation (visual analogue scale, 0-10 where 0 is none and 10 the worst), cure/improvement defined as >50% reduction compared to baseline
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients showing improvement (reduction) in induration after treatment
Time Frame: 5 months
digital testing of pelvic induration by physician (scale: high, moderate, none) compared to baseline
5 months
Number of patients showing improvement (reduction in questionnaire sum) in symptoms as assed by subjective questionnaire
Time Frame: 5 months, 12 months
subjective evaluation by validated questionnaire (Genitourinary Pain Index for Women, sum scale 0-45, the lower the value the lower the symptoms) compared to baseline
5 months, 12 months
Number of patients reporting pain during laser treatment
Time Frame: 3 months
VAS (visual analogue scale, 0-10 where 0 is none and 10 the worst) pain score during laser treatment
3 months
Number of patients showing urethral infections before and after treatment
Time Frame: 5 months
Analysis of urethral infections before and after treatment using urine dipstick test (positive/negative)
5 months
Number of patients reporting satisfaction with treatment outcome
Time Frame: 5 months, 12 months
subjective evaluation of improvement (patient global index fo improvement, 7-item scale from "very much worse" to "very much better"), cure/improvement defined as response "much better" or "very much better"
5 months, 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients reprting good tolerability ("good" or "very good") of vulvar creams in combination with laser treatment
Time Frame: 5 months
Patient satisfaction (5-item scale from "not at all" to "very good") on the use of vulvar creams
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Volker Viereck

Investigators

  • Principal Investigator: Volker Viereck, Prof. Dr., Cantonal Hospital, Frauenfeld

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 30, 2022

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pilot UPS-IUL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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