Introduction and Objective.

The  US published (1997) minimal standards to assess the efficacy of therapy for UI . The standards were developed by a US committee and were approved by American Urological Society. The US intended that clinical and basic science research studies in UI would adopt these standards and report their findings according to this format. The objective of our study was to evaluate compliance with these standards in recent UI research studies.

 

Methods.

A Medline search was conducted for all articles in which outcomes of treatment for UI were reported (Nov 1997 - October 1999). A table containing the minimal recommended standards was developed which included pre-treatment data on: (a) micturition history; (b) structured physical exam (PE); (c) neurological and vaginal exams; (c) micturition diary; (d) pad test; (e) urodynamic studies (UDS). Post-treatment data were recommended on the same categories (a-e) as well as Quality of Life (QOL), Uroflowmetry and post-void residual (PVR). The data reported in each article were extracted and compared to the recommended standards. Compliance rates for each data field was calculated by percentages for (a) the individual article and (b) overall compliance rate among all articles. Not all data standards appeared relevant to some studies, so the denominator varied.

 

Results.

A total of 45 articles that reported treatment for UI were selected. The treatments included various sling procedures, injectables, pharmacological treatments, and mechanical valves. The compliance rate for individual article ranges from 25% -65% of recommended data. Table below shows the overall compliance rate for each data field among all the reports.

 

Pre-treatment: Compliance	MictHist 50%	P.E. 60%	NeuroEx 20%	VagEx 63%	Diary 30%	PadTest 25%	UDS 58%
Post-treatment	MictHist 27%	P.E. 63%	Diary 25%	PadTest 30%	UDS 12%	Uroflow 43%	PVR     43%	QOL 15%

 

Conclusions.

We conclude that there is far less than optimal reporting of outcomes for treatment of UI per the recommendations of the Urodynamic Society. This low compliance makes standardized evaluation of treatment outcomes difficult if not impossible. Without the ability to standardize evaluation of published studies fair and objective comparisons cannot be made. Research in UI should be designed to accommodate national guidelines.