GAG Replacement vs URethral DIlAtatioN

NCT03861260 | Withdrawn

• 1 other identifier: 2018-FAM-99
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomised parallel trial is to compare the efficacy of Glycosaminoglycan layer replacement against cystoscopy and urethral dilatation in the treatment of recurrent urinary tract infection in pre-menopausal women. The women will be randomised to 1 of 2 arms.Arm 1 patients will receive standard treatment from the Urologists. This will involve rigid cystoscopy and urethral dilatation, under general anaesthetic. Arm 2 patients will receive standard treatment from the Gynaecologists.

Conditions

Recurrent Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• The number of Urinary tract infections in the 12 months following treatment

  Number of symptomatic UTI episodes in 12 months following treatment

  12 months

Secondary Outcomes (6)

• The time to first urinary tract infection after completion of treatment.

  12 month study period

• The change in the Quality of life (QoL) between the time of treatment and at 3, 6 and 12 months following initiation of treatment.

  3, 6 and 12 months

• The number of adverse events recorded following treatment during the 12-month study period

  12 months

• The change in the Patient Satisfaction at 3, 6 and 12 months following initiation of treatment

  3, 6 and 12 months

• The change in female sexual function index (FSFI) questionnaire at 3, 6 and 12 months

  3, 6 and 12 months

Study Arms (2)

Rigid Cystoscopy and Urethral dilatation

OTHER

Rigid cystoscopy, performed under General Anaesthetic, followed by intervention of urethral dilatation with Hagar dilators.

Procedure: Rigid cystoscopy with urethral dilatation

Flexible cystoscopy and Glycosaminoglycan Layer replacement

OTHER

Flexible cystoscopy, under Local Anaesthetic, followed by the intervention, which is 6 installations of Ialuril (a Glycosaminoglycan Layer replacement)

Procedure: Flexible cystoscopy and installation of Glycosaminoglycan layer replacement (laluril)

Interventions

Rigid cystoscopy with urethral dilatation PROCEDURE

Patients will have a general anaesthetic and a rigid cytoscopic examination of the bladder dilated with sterile water. The urethra will be dilated from FR20 in incremental diameter increases of 2 to French 32 if possible.

Rigid Cystoscopy and Urethral dilatation

Flexible cystoscopy and installation of Glycosaminoglycan layer replacement (laluril) PROCEDURE

Patients will undergo flexible cystoscopy and intravesical installations of Hyaluronic acid (HA) + Chondroitin Sulphate (CS) (GAGs) weekly for 4 weeks and then at 8 weeks and 12 weeks.

Flexible cystoscopy and Glycosaminoglycan Layer replacement

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Pre-menopausal 3 - 3 episodes of cystitis in the last 12 months as defined by:
• symptoms from dysuria, frequency, urgency, suprapubic tenderness, haematuria, polyuria
• Or less than 2 symptoms from the above list, but with cloudy urine 4 - Normal flow studies with bladder residual \<150ml 5 - Normal renal tract on USS

You may not qualify if:

• \- Anatomical anomalies of urinary tract
• \- Neurological condition
• \- Diabetes mellitus
• \- Pregnancy
• \- Use of Immunosuppressants
• \- Symptomatic of UTI at time of treatment

Sponsors & Collaborators

• Hampshire Hospitals NHS Foundation Trust: lead

Study Sites (1)

Hampshire Hospitals NHS Foundation Trust

Basingstoke, Hampshire, RG24 9NA, United Kingdom

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Christian Phillips, MBBS MD

  Hampshire Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: March 4, 2019
• Study Start: April 30, 2019
• Primary Completion: October 28, 2019
• Study Completion: October 28, 2019
• Last Updated: September 27, 2021

Record last verified: 2021-09

Locations

GB (1)