Evaluation of self instillation of chondroitine sulfate versus instillations given by a dedicated nurse in the treatment of patients suffering from Bladder Pain Syndrome

Hjuler A1, Rasmussen S A1, Jensen B T1, Ryhammer A M1

Research Type

Clinical

Abstract Category

Pelvic Pain Syndromes / Sexual Dysfunction

Abstract 60
Interstitial Cystitis / Bladder Pain Syndrome 1
Scientific Podium Short Oral Session 6
Wednesday 29th August 2018
11:07 - 11:15
Hall C
Painful Bladder Syndrome/Interstitial Cystitis (IC) Clinical Trial Nursing
1. Pelvic Floor Unit, Dep.of Urology, Aarhus University Hospital, Denmark
Presenter
A

Annette Hjuler

Links

Abstract

Hypothesis / aims of study
Instillation of chondroitin sulphate (CS) in the bladder is one of the cornerstones in treatment of Bladder Pain Syndrome (BPS). CS is instilled into the bladder via a catheter and contributes to the repair of a defective GAG layer. Treatment is administered in weekly sessions over a course of 6 weeks. Many hospitals let patients come to the institution and have a nurse do the catheterization and instillation (nurse provided instillation, NPI). We have for several years taught patients to perform clean intermittent self catheterization (CISC) and let them do self instillations (SI) in their own home. We have, however, never evaluated the treatment systematically.

To find out if treatment results depend on whether patients do SI or NPI and to evaluate whether patients had any preference at the end of treatment. Finally we wished to estimate possible differences in resources spent for both patients and nurses.
Study design, materials and methods
The study was a randomized cross-over study with a treatment period of 12 weeks. Patients were randomized to either 6 weeks SI followed by 6 weeks NPI (SI/NPI group) or 6 weeks NPI followed by 6 weeks SI (NPI/SI group). Before starting SI patients were trained in accordance with the department´s instructions on CISC during their first visit. Patients were allowed to contact our clinic at any time during the treatment period. During NPI patients came to the clinic once every week. Twenty patients were included in the study, ten in each group.
All patients kept a daily record of pain, urgency and number of daily voiding. Upon inclusion in the study, patients filled in a questionnaire. This was filled in again after 6 and 12 treatments. For the evaluation of possible treatment differences between NPI and SI treatment results were evaluated after the initial six weeks. For the evaluation of the remaining parameters results after 12 weeks’ treatment were used
Results
Fifteen of twenty included patients completed the study. One was excluded due to inability to be taught CISC. Two were excluded since they did not want to do NPI after having done SI. Two were excluded due to other reasons.

Treatment effect was lower in the SI/NPI group after 6 weeks as seen in Table 1. Pain score in the NPI group was reduced from 2.7 to 1.3 on a pain VAS scale, whereas pain score was reduced from 3.1 to 2.4 in the SI group. Similar results were seen regarding changes in urgency and number of voiding.
Seven of the SI patients had a contact to the clinic by phone all were due to urinary tract infection (UTI). This  consultation lasted on average 15 minutes. These telephone contacts were all in the beginning of the SI treatment. No patients contacted the clinic or experienced a UTI during their NPI treatment period.
All patients reported that they felt safe doing SI and were well-informed regarding the SI procedure. Time spent for the patients on the SI procedure was on average 10 (range 5 – 15) minutes and for NPI 120 (range 60 – 180) minutes, this was including transportation. This means that patients spent 720 minutes on 6 NPI treatments as opposed to 60 minutes when performing SI.
The time spent by nurse during NPI is 30 minutes per treatment adding up to 180 minutes for 6 treatments. When teaching patients CISC and SI 60 minutes are spent for the first treatment. This means that letting patients perform SI reduces nurse resources by 120 minutes per patient.
After 12 weeks´ treatment all patients were asked to report which treatment modality they would prefer. All preferred to do SI and for all patients this was due to the shorter time spent on SI compared to NPI.
Interpretation of results
It appears that NPI give better treatment results than SI when looking at self-reported bladder symptoms like pain, urgeny and number of voidings. The better treatment results are, however, not reflected in results regarding treatment satisfaction and patients’ preferences regarding treatment modality. All patients preferred to do SI as opposed to NPI despite the better treatment results and the possibility of having a consultation with a health care professional when given the NPI. UTI is a complication related to SI, probably indicating a learning curve for the patients performing CISC
Concluding message
In a public health care system resources are limited and it is therefore an interesting finding that SI is preferred by patients and can be performed in a safe and satisfactory way. SI offers a substantial reduction in resources and time spent for both patients and nurses. There is, however, a difference in treatment results in favour of NPI. A low treatment effect on general, independent of treatment modality, might explain why patients prefer SI despite the poorer treatment results.
Figure 1
Disclosures
Funding Chondroitin sulfate for the patients was funded by Navamedic ASA, Fornebuveien 42-44, P.O.Box 107, N-1325 Lysaker, Norway Clinical Trial Yes Public Registry No RCT Yes Subjects Human Ethics not Req'd We sent the protocol to our local EC and received the answer that approval was not necessary Helsinki Yes Informed Consent Yes