Gen Research Ed

8/3/2019 Gen Research Ed

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UNIVERSITY OF BOTSWANA/AFFILIATED

HEALTH TRAINING INSTITUTIONS

RESEARCH PROPOSAL

TOPIC: ERECTILE DYSFUNCTION

COMPLIED BY: PHILLIMON TIKOLOGO- 2634

KEBOLETSE LEKHANE -2611

GOITSEMODIMO ELIJAH NKWENA-2628

EXAMINER: MR MALELE

PROGRAMME: MEDICAL LABORATORY TECHNOLOGY

YEAR: 2010


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TABLE OF CONTENTS

ACKNOWLEDGEMENTS...i

ABSTRACT....ii

1.0INTRODUCTION.....1 1.1Background information................................11.2Statement of the problem...11.3General objective...11.4Specific objectives.....31.5Hypothesis......31.6Significance of the study....31.7Limitations..3-41.8Definition of terms and abbreviations............................4

2.0LITERATURE REVIEW..5-63.0METHODOLOGY....7

3.1Study design...73.2Population..73.3Sample and sampling procedures...................................................................73.4Quality control...83.5Plan for data collection..83.6Data presentation and analysis...8-93.7Ethical considerations....93.8Variables......10

REFERENCES...11

APPENDIX....12 -14

ANALYTICAL DIAGRAM..15


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ACKNOWLEDGEMENTS

Compilation of this research proposal would not be a success without support, leadership and

encouragement we got from other people. The research team gives a sincere thank you to our

research lecture, Mr. O. Malele, for his patience and enthusiasm as well as his expert advice

throughout this research proposal. We gratefully thank our Medical Laboratory Technology

department lecturers for helping us when choosing a research topic and their advice in the

proposal development. The resource centre staff is also appreciated for granting us permission

for accessing the internet and printing our research proposal as well as the library staff for

patiently helping us find the relevant sources for the development of our research proposal.

Finally we gratefully thank our fellow classmates who sympathetically gave us sources (e.g.

textbooks, articles and websites) relevant to our study question.


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1.0 INTRODUCTION

1.1 BACKGROUND INFORMATION

Although erectile dysfunction is not a life threatening diseases it has lead to some relationship

breakups.ED is a persistent inability to achieve and/or maintain a penile erection sufficient for

satisfactory sexual performance. in diabetic patients complications such as cardiovascular

diseases, obesity, physical inactivity, tobacco smoking and hypertension contribute to increased

risk of acquiring ED( S Rastogi 2005).

Montarsi et al (2005) carried out a similar research and found that the rate of ED in patients with

coronary artery diseases (CAD) to be as high as 42-57%,likewise Gazzaruso et al found the

incidence of ED in diabetic patients with silent ischemia to be 33.8% compared to 4.7% in those

without silent ischemia.

When assessing erectile dysfunction and cardiovascular diseases by Shane et al (2004) found that

penile erection function is the result of a complex interplay between vascular, neurologic,

hormonal and physiological factors. Attainment and maintenance of a firm erection requires

good arterial inflow of blood and efficient trapping of venous outflow, then these disease

processes that affect the function of the arterial and erectile function.

Nakanishi et al (2004) on his research titled ED linked with decreased libido on diabetic men

found that the consistent inability to attain and maintain an erection sufficient for sexual

intercourse is defined as erectile dysfunction. Diabetic men frequently develop erectile

dysfunction as one of the symptoms related to diabetic neuropathy. The incidence of erectile

dysfunction ranges from 28 to 59% in diabetic men, and this has been reported to be

approximately three to eight times higher than that in non-diabetic men. Although erectile

dysfunction is not a life threatening disease, it markedly affects the quality of life of patients. In

addition, the appearances of a new drug and newspaper advertisements have recently caused

public concern about erectile dysfunction. The number of patients with diabetes is increasing

and, hereafter, the number of patients who want to be treated for erectile dysfunction may also

increased. Therefore, surveys on the present condition of erectile dysfunction, including the

number of the patients, may be important.


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Rodriguez et al ,(2005) investigated the relationship between heart failure and erectile

dysfunction and found that Coronary artery disease (CAD) and erectile dysfunction (ED) are

both highly prevalent conditions that frequently occur concomitantly.16 They share mutual risk

factors, including diabetes mellitus (DM), hypertension, hyperlipidaemia, obesity and tobacco

abuse.14 As the number of cardiovascular risk factors increase, so does the incidence of both

CAD and ED.3,4 These similarities have led to a renewed interest in further defining the

similarities between these diseases. Atherosclerosis is a systemic disease, and it is reasonable to

expect penile atherosclerosis and resultant ED to occur in patients with CAD. In a review of

seven major studies including 700 cardiac patients. This shows that there are associations

between erectile dysfunction and the risk factors.

1.2 STATEMENT OF THE PROBLEM

The purpose of this study is to assess the prevalence of erectile dysfunction(ED) and to find out

associations between risk factors (diabetes mellitus and cardiovascular diseases) and ED in

20years patients and above of male population.

In evaluation of ED David (2000) found that, in Men problems with arousal(ED) are common.

Among 1290 non institutionalized men between the ages of 40 and 70yeras an estimated 5-15%

reported severe ED and 17-34% reported moderate ED.The ages adjusted probabilities calculated

for complete ED were 39.1% in men treated for heart diseases,28% in treated diabetes and 15%

in treated hypertension therefore ED is associated with diabetes mellitus and cardiovascular

diseases. Smoking and lower HDL cholesterol also correlated with increased ED. ideally

etiology should direct therapeutic selection. However ED diagnostic techniques are not readily

available to many physicians, are not fairly refined, and are expensive.

1.3 GENERAL OBJECTIVE

To find out the relationship between risk factors (diabetes mellitus and cardiovascular diseases)and erectile dysfunction.


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1.4 SPECIFIC OBJECTIVES

To determine effective management of ED

To determine effects of risk factors on the severity of ED

To find out the prevalence of ED in areas of study and compare findings with published results

of same study.

To find out the pathophysiology of ED on patients with diabetes mellitus and cardiovascular

diseases.

1.5 HYPOTHESIS

People with cardiovascular diseases and diabetes mellitus are more susceptible to erectile

dysfunction than those who are not diabetic or have cardiovascular diseases.

1.6 SIGNIFICANCE OF THE STUDY

Erectile dysfunction is often under diagnosed because of reluctant patients and physicians to

discuss ED as a medical problem therefore this study will raise awareness on both physicians and

patients and help the latter get medication at an earlier stage hence prevent the progression to

complete ED.

It can help the ministry of health (MOH) to evaluate the risk factors of ED and be able to

implement programmes aimed at educating the public about the issues of importance concerning

their health status on ED and be able to come up with remedies to ED problem.

1.7 LIMITATIONS

Due to time constraints the data will be collected from only two health centers being PMH and

Bontleng. This hinders research accuracy as the data collected cannot represent the entire

population. The time factor played an important role in hindering progression of the development

of our research proposal, school schedule was tight, having to run between preparing for tests

and compiling our research proposals which required more time and ultimate attention.


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Development of research proposals required application of research concepts which was not easy

as we were expected to do our research proposal simultaneously learning the concepts in class.

Our data collection involved the retrospective research design (using information found by other

researchers). This was rather disadvantageous as it is possible that the researchers leave some

facts out, which are important to our study. Another obstacle in our research proposal

development was inadequate resources. At times the computers at the resource centre in school

were all occupied, this hindered in collecting information from the internet well in time. Printer

break downs at the resource centre required us to print our work with our own cash, which was

not available at times.

1.8 DEFINITION OF TERMS AND ABBREVIATIONS

DEFINITION OF TERMS

Prevalence- alteration in number (either high or low)

Penile tumescence- erection

Penile detumescence- return to flaccid state

ABBREVIATIONS

CAD- Coronary artery disease

CC- corpus covernosum

PMH-Princess Marina Hospital

ED-Erectile Dysfunction

DM-Diabetes Mellitus

MoH-Ministry of Health

SM-smooth muscle


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2.0 LITERATURE REVIEW

Penile tumescence (erection) and penile detumescence (return to the flaccid state) are regulated

by a complex neurophysiological process involving the relaxations and contractions respectively

of the smooth muscle within the corpus covernosum of the penis. Failure of the above smooth

muscle mediated process to function is erectile dysfunction. In a related research carried by

Michael et al (2005) on contractile mechanisms in diabetes-related erectile dysfunction found

that it is predicted that an estimated 322 million men worldwide will have ED by the year 2025

and relevant to this review article 50% of men with diabetes will also have ED.

Shane et al (2004) also found out that according to estimates from National Institutes of Health

ED affects 10 million -20million men in USA. Worldwide, more than 100 million men are

believed to have ED. Furthermore Shane et al(2004) in a survey found out that an estimated

500 000 patients a myocardial infarction each year in USA, and as estimated 11 million patients

have an existing cardiovascular disease making the issue of sexual function and cardiac

diseases relevant to many patients.

A study carried out by Nakanishi et al (2004) linking ED with decreased libido on diabetic

patients showed that erectile dysfunction frequently occurs with diabetes mellitus. A survey of

diabetic men was conducted by anonymous questionnaire to investigate the associations of

erectile dysfunction with various predictive factors. A total of 112 diabetic males without an

obvious history of erectile dysfunction were available for analyses. The mean age and duration

of diabetes were 53.7+12.2 years and 10.2+8.6 years (mean +standard deviation), respectively.

The questionnaire included questions on the presence or absence of smoking, hypertension,

libido and subjective symptoms of diabetic neuropathy that may be associated with erectile

dysfunction. Analysis of the answers to the questionnaire revealed that 40% of the patients

complained of erectile dysfunction (erection always insufficient). Erectile dysfunction was

significantly correlated with age but not with duration of diabetes. Erectile dysfunction was also

associated with sensory neuropathy and reduced libido, independently of age. The logistic

regression analysis revealed that erectile dysfunction was positively associated with reduced

libido and age. The odds ratio of erectile dysfunction for reduced compared to unreduced libido

was 18.21, suggesting that psychogenic factors have a marked influence on erectile dysfunction.


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It is concluded that the presence of erectile dysfunction should be considered when symptoms

related to diabetic neuropathy are observed; psychological approaches, such as sexual

counseling, could be applied for the treatment of erectile dysfunction.


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3.0 METHODOLOGY

3.1 STUDY DESIGN

A descriptive/observational case study design will be used to collect data as it provides in depth

analysis of a subject for assessing the prevalence of ED in patients with cardiovascular diseases

since it quantifies associations between variables.

3.2 POPULATION

The target population will be male diabetic patients aged 20 years and above with cardiovascular

disease presenting with erectile dysfunction who were admitted at Princess Marina hospital and

Bontleng clinic in the year 2009.

3.3 SAMPLE AND SAMPLING PROCEDURE

The sample will be 50 participants who will be randomly picked from both Princess Marina

Hospital and Bontleng clinic, that is; 25 patients will be picked from each clinic making a total

number of 50 patients. Convenience sampling method will be used to pick the first 25

participants at PMH who will be willing to participate and the same procedure will be used at

Bontleng clinic. Convenience sampling method is a much more convenient way of selecting a

sample since it saves time and reduces costs.

For the records, we will use systematic sampling where by the numbers or elements of the

sample are chosen in some regular manner, according to a system of fixed intervals which

involves selecting every seventh or tenth name on a list. The first number to determine the

interval will be selected using a table of random numbers depending on the sample size. We will

collect all erectile dysfunction patients results from both princess marina hospital and Bontleng

clinic for the year 2009. In these patients, the first number to determine the interval will be

selected using a table of random numbers, and then the other numbers will be selected based onthe interval determined by the first chosen number.


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3.4 QUALITY CONTROL

To ensure quality control, all incomplete answered questions, repetitions will be omitted. During

data collection, questions that the respondents do not understand the research team will clarify

them. To avoid bias in our study, respondents will not be forced to respond, it will be voluntary.

To ensure relevance the questionnaire will not have any complex or ambiguous questions so that

respondents do not interpret them differently. Data will be backed up when using a computer. All

data put into computer will be cross checked with the one in questionnaires for any typing error

and all questionnaires will be checked whether they are complete and consistence.

Pretesting will be carried out to test our tool. About 10 subjects will be interviewed to check the

flow of questions, determine if the question address the objectives, check the repetition of

questions, estimate non response rate, and the actual time of survey.

3.5 PLAN FOR DATA COLLECTION

Questionnaire is the most preferred method of data collection as it is much less costly and

requires less time to administer. They offer the possibility of complete anonymity, respondents

also tend to be more comfortable and therefore there will be no bias in their responses. The

questionnaire will contain closed ended questions. This is to ensure comparability of responses

and to facilitate analysis. Closed ended questions also require short amount of time for

respondents to answer the questionnaires.

Data will also be collected from medical records at Princess Marina Hospital and Bontleng

clinic. The research team will access data from diaries that shows past prevalence. Medical

professionals from these health centers will be informed well in advance to air their views and

observations about prevalence of erectile dysfunction in diabetic patients with cardiovascular

diseases.

3.6 PLAN FOR DATA PREPARATION AND ANALYSIS

Data will be collected by the research team, in approximately 7 days. Using a Microsoft excel,

data will be analyzed and presented in bar graphs and pie charts to show percentage prevalence

of erectile dysfunction. Data from medical reports will be analyzed using content analysis.


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Responses from participants will also be analyzed accordingly with similar responses grouped. A

questionnaire will be used, with questions categorized according to the similarity of responses

from each questionnaire. For confidentiality data will be stored as an encrypted file in computer.

Hard copies will be kept in lockable shelves. Questionnaires will be numbered and kept in locked

shelves according to assigned numbers. Anyone who wants to access the information with valid

reasons will need permission from research team and their presence at that time.

3.7 ETHICAL CONSIDERATIONS

The research team will submit the proposed research to the appropriate persons and is willing to

comply with the authority recommendations. Permission for carrying out the study will be

granted from the institute authorities. At the beginning of the study, the research team will not

withhold information about the purpose and nature of the study as well as what is expected from

them. Participants will be assured of anonymity and confidentiality. The research team will not

disclose what they learn about patients. The anonymity of the participants will be maintained by

avoiding personality identifiable information on data collection forms, substituting code numbers

for names and keeping a master list under lock and key in a separate place. Confidentiality of

data sources will be presented by limiting access to completed questionnaires by people.

Unauthorized access to the data will be prohibited and should any individual with valid reasons

wish to access data may do so only with the research team.


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3.8 VARIABLES

Variable Operational variable Scale of measurement

gender Male

female

nominal

Qualification General practitioner

General nurse

specialists

ordinal

Years in service 0-5 years

5-10 years

10 and above

ordinal


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REFERENCES

Burns, N & Grove, S.(1999).Understanding nursing research.(2nd

edition).Philadelphia W-B

Saunders.

Cormack, D. (1991) the research process in nursing, 2nd

edition, Blackwell scientific oxford, 20-

24

Gazzaruso, C. (2008) Erectile dysfunctionas a predictor ofcardiovascularevents and death in

diabetic patients withangiographically proven asymptomatic coronary artery disease,Journal of

the American College of Cardiology, 51, 2040-2044.

Latime, J. (2003). Advanced qualitative research for nursing. New York: Blackwell Publishing.

Michael, E. (2005) Contractile Mechanisms in Diabetes-Related Erectile Dysfunction, Bentham

Science Publishers Ltd. USA

Nakanishi S et al, (2004) The Aging Male, Parthenon Publishing. 7, 113119,

Rastogi, S. (2005) Linking erectile dysfunction and coronary artery disease, International

Journal of Impotence Research

Stone D. (1995)Design a questionnaire,British medical journal, 307, 1264-1266

Shane, T. (2004) Erectile Dysfunction and Cardiovascular Disease, Mayo Foundation for

Medical Education and Research, 79,782-794


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APPENDIX

APPENDIX 1

INSTRUMENT FOR DATA COLLECTION (for clinicians and doctors)

QUESTIONNAIRE

HEALTH CENTRE: Marina Bontleng (tick where appropriate)

Age (yrs): 2125 2630 3135 3640 4550

Above 50

Gender: Male Female:

Post in the health centre: Nurse Doctor others, specify

.

Duration in service: o5 yrs 610 yrs 11and above

Number of malepatients20 yrs with DM IN 2009: 015 1630 3145

> 45

Number of malepatients20 yrs with cardiac disease in 2009: 0 15 1630

3145 > 45

Of the above mentioned two cases, how many patients presented with ED: 015

1630 3145 > 45

Is there any relationship between erectile dysfunction, diabetes mellitus and cardiovascular

diseases? Yes No


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APPENDIX 2

INSTRUMENT FOR DATA COLLECTION (for patients)

QESTIONNAIRE

Age (yrs): 2125 2630 3135 3640 4550

> 50

Are you diabetic? Yes No

If yes for how long have you been diagnosed? 05 yrs 610 yrs > 10 yrs

Have you been diagnosed with cardiovascular disease? Yes No

If yes which one? CAD Atherosclerosis others, specify

If yes for how long have you been diagnosed? 05 yrs 610 yrs > 10 yrs

Do you have ED? Yes No

If yes what is the general nature of your erection? No erection weak short

termed


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APPENDIX 3

CONSENT FORM

We, Phillimon Tikologo, Keboletse Lekhane and Elijah Nkwena, trainees at Institute of Health

Sciences-Gaborone are carrying out a research on erectile dysfunction on male diabetic patients

aged 20 years and above with cardiovascular disease reported in the following health care

centers; PMH and Bontleng clinic. We would be grateful if you could consider participating in

this study.

To ensure anonymity, provision of your identity is not expected from you and the information

you give will be treated with confidentiality. Participation is voluntary and if you wish not to

take part in the study, you are free to do so.

I hereby agree to take part in the study and assist you with any information

that will be relevant to your study. I therefore declare that my participation will be voluntary and

the study has been well explained to me.

Date:

Signature:


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ANALYTICAL DIAGRAM

Erectile

dysfunction

DiabetesMellitus

Cardiovascularrisk factors;

CAD,

atherosclerosis

Neurological

diseasesPsychosexual

disease

Impairment

Functional

neural system

Penile erection

Psychogenic

erection

Reflex erection

Touching the

penile shaft

Limbic system

of the brain

Peripheral nerves

and the lower part

of the spinal cordErotic or emotionalstimulus

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