The use of bladder instillations with hyaluronic acid in the management of young female patients with lower urinary tract symptoms and trigonitis

ISRCTN	ISRCTN11263175
DOI	https://doi.org/10.1186/ISRCTN11263175

Submission date: 17/03/2021
Registration date: 12/05/2021
Last edited: 12/05/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Trigonitis is inflammation of the trigone region of the bladder. Although trigonitis was first described more than a century ago and is a familiar term to urologists, it remains a poorly defined condition. The diagnosis is done during cystoscopy (camera inspection of the bladder) by the image of a white patch of tissue in the bladder trigone (the area between the bladder neck and the two ureteric openings). The precise underlying cause is still not well understood and its clinical significance continues to be unclear. Trigonitis has been traditionally associated with a wide range of lower urinary tract symptoms as well as with recurrent urinary tract infections. However, not all people with trigonitis have symptoms, and not all symptomatic patients have trigonitis, which complicates the understanding of this elusive disease process. The aim of this study is to find out whether the use of intravesical hyaluronic acid (treatment given directly into the bladder) in symptomatic women with trigonitis can improve their symptoms.

Who can participate?
Young women of reproductive age with persistent lower urinary tract symptoms and evidence of trigonitis on cystoscopy

What does the study involve?
All patients receive 10 weekly and 10 monthly treatment sessions of hyaluronic acid solution inside the bladder for a period of 1 year, which is known to repair the lining of the bladder wall. Their response to treatment is evaluated with symptom questionnaires. Each patient is assessed with a cystoscopy and biopsy (tissue sample) of trigonitis at the beginning and the end of the study.

What are the possible benefits and risks of participating?
Benefits include potential improvement of symptoms following treatment with hyaluronic acid. Risks include potential side effects from the drug which according to previous studies are very rare. Risks also include complications from bladder instillations such as a urinary infection and also potential complications from cystoscopy and bladder biopsy performed before and after treatment such as bladder discomfort/pain, infection and bleeding.

Where is the study run from?
National and Kapodistrian University of Athens (Greece)

When is the study starting and how long is it expected to run for?
October 2009 to April 2017

Who is funding the study?
National and Kapodistrian University of Athens (Greece)

Who is the main contact?
Mr Marios Stavropoulos FEBU
Marios.Stavropoulos@addenbrookes.nhs.uk

Contact information

Mr Marios Stavropoulos
Scientific

Newton 9A, Puddicombe Way
Cambridge Biomedical Campus
Cambridge
CB2 0AB
United Kingdom

ORCID ID	0000-0002-3908-9706
Phone	+44 (0)7549862922
Email	Marios.Stavropoulos@addenbrookes.nhs.uk

Mr Marios Stavropoulos
Public

Newton 9A, Puddicombe Way
Cambridge Biomedical Campus
Cambridge
CB2 0AB
United Kingdom

Phone	+44 (0)7549862922
Email	stamarios@yahoo.gr

Study information

Study design	Prospective non-randomized uncontrolled study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	The use of intravesical hyaluronic acid in the management of symptomatic premenopausal women with pseudomembranous trigonitis
Study objectives	The use of intravesical hyaluronic acid in symptomatic women with trigonitis can improve their symptoms.
Ethics approval(s)	Approved 13/11/2009, Sismanoglio Hospital Ethics Committee (Sismanogliou 1, Marousi 15126, Athens, Greece; +30 (0)2108039254; info@sismanoglio.gr), ref: 19750
Health condition(s) or problem(s) studied	Treatment of lower urinary symptoms in women with trigonitis
Intervention	Intravesical administration of 40 mg/50 ml solution of sodium hyaluronate (Cystistat) once weekly for 10 weeks and once monthly for 10 months thereafter to all patients.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Cystistat (sodium hyaluronate)
Primary outcome measure	1. Pain and urgency measured using the visual analogue scale (VAS) at baseline, 10 weeks and 12 months 2. Further symptoms and quality of life measured using the Pain and Urgency/Frequency (PUF) symptom scale at baseline, 10 weeks and 12 months
Secondary outcome measures	Extent of trigonitis measured using cystoscopy and biopsy at baseline and end of treatment at 12 months
Overall study start date	08/10/2009
Completion date	02/04/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	30
Total final enrolment	37
Key inclusion criteria	Women of reproductive age with lower urinary tract symptoms for at least 6 months and trigonitis seen on cystoscopy
Key exclusion criteria	1. Under 18 years 2. Pregnancy or breastfeeding 3. Radiation cystitis 4. Neurogenic bladder 5. Bladder cancer 6. Bladder stones 7. Stress incontinence 8. Urethral diverticulum 9. Pelvic organ prolapse 10. Uterine, vaginal or cervical cancers 11. Endometriosis
Date of first enrolment	07/01/2010
Date of final enrolment	04/02/2016

Locations

Countries of recruitment

Greece

Study participating centres

Sismanoglio Hospital

2nd Department of Urology
School of Medicine
University of Athens
Sismanogliou 1
Athens
151 26
Greece

Attiko Hospital

3rd Department of Urology
School of Medicine
University of Athens
Rimini 1
Athens
124 62
Greece

Sponsor information

National and Kapodistrian University of Athens
University/education

Department of Medecine
75 Mikras Asias str
Athens
115 27
Greece

Phone	+30 (0)210 746 2002 - 3
Email	secr@med.uoa.gr
Website	http://en.uoa.gr/
"ROR"	https://ror.org/04gnjpq42

Funders

Funder type

University/education

National and Kapodistrian University of Athens
Government organisation / Local government

Alternative name(s): University of Athens
Location: Greece

Results and Publications

Intention to publish date	01/04/2021
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal
IPD sharing plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Editorial Notes

12/05/2021: Trial's existence confirmed by the Sismanoglio Hospital Ethics Committee.