Summary
Evidence Report/Technology Assessment: Number 109
Under its Evidence-based Practice Program, the Agency for Healthcare Research and Quality (AHRQ) is developing scientific information for other agencies and organizations on which to base clinical guidelines, performance measures, and other quality improvement tools. Contractor institutions review all relevant scientific literature on assigned clinical care topics and produce evidence reports and technology assessments, conduct research on methodologies and the effectiveness of their implementation, and participate in technical assistance activities.
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Introduction / Methods / Results and Discussion / Availability of Full Report / References
Authors: DeForge D, Blackmer J, Moher D, Garritty C, Cronin V, Yazdi F,
Barrowman N, Mamaladze V, Zhang L, Sampson M.
Introduction
Spinal cord injury (SCI) is most often the
result of a trauma to the spinal cord, but can also
be associated with congenital or degenerative
disease. In the United States alone currently there
are approximately a quarter million people with
SCI. Every year, approximately 10,000 people in
the United States survive an acute traumatic
injury to the spinal cord. The majority of these
people are male and under the age of 25.1 In
addition to paralysis, persons with SCI will likely
experience problems with bladder and bowel
control, as well as alterations in sexual
functioning.1,2-4
The impact of a SCI on sexual
functioning depends on the degree of the injury
and its location on the spinal cord.5,6 Sexual
dysfunction in persons with SCI may have both
physiologic and psychological (e.g., body image,
self esteem) elements that can be distressing
regardless of the person's gender, age, or culture.
Both men and women report a decreased
desire for sexual activity following their injury.7,8
Frequency of sexual activity is also known to
decrease after injury in both men and women.7,8
In men with SCI, factors affecting sexuality
typically include erectile and ejaculatory
dysfunction.9-11 Factors affecting women with SCI
may include difficulties having comfortable
intercourse, and the ability to reach or feel
orgasm.5,12,13
Although some men with SCI are unable to
have erections, many still maintain the ability to
have some erectile function, albeit of insufficient
quality and duration for intercourse.14 Possible
treatments include devices such as the vacuum
erection device as well as the injection of
vasoactive drugs into the penis.15,16 A recent
innovation to improve erectile function in men
with SCI has been the approval of the drugs such
as sildenafil (Viagra®). Infertility is an issue for
men with SCI14,17,18 more than with women. Male
infertility results from the combination of
ejaculatory dysfunction and abnormal sperm
quantity and quality. Techniques to remediate
erectile dysfunction and ejaculation have vastly
improved the fertility potential of men with
SCI.19-23 Stimulation to obtain ejaculate for
insemination of a partner is now routinely
performed. Usually, ejaculate is obtained through
the use of penile vibratory stimulation or
electroejaculation, but other techniques to treat
SCI-related male infertility are myriad.
Health care providers have become increasingly
aware of the importance of sexuality in the
rehabilitation process.22,23 Current approaches to
"best practices" concerning the topic of sexuality
and reproductive health in persons with SCI are
opinion-based, typically generated by clinical
experience with small patient populations in select
hospitals and rehabilitation facilities. The
Consortium for Spinal Cord Medicine (sponsored
by the Paralyzed Veterans of America) has
identified the issue of sexuality and reproductive
health to be a high priority topic for improving
the quality of life for persons with SCI.
Last year, at the request of the Consortium for
Spinal Cord Medicine, the Agency for Healthcare
Research and Quality (AHRQ) commissioned the
University of Ottawa's Evidence-based Practice Center (UO-EPC) to conduct a feasibility study to determine if
there is sufficient credible literature to support a comprehensive
systematic review on the topic of "Sexuality and Reproductive
Health Following SCI." In this feasibility report a reasonably
large body of evidence was identified examining different
aspects of sexuality and reproductive health following SCI. In
general, these studies are of a lower level of evidence and open
to several sources of bias. Therefore, AHRQ requested a
comprehensive evidence report that incorporates and builds on
findings from the UO-EPC phase I feasibility study.
Key Questions
As a result of findings from the phase I feasibility study, this
report focuses on two questions and their sub-questions.
Question 1 focuses on issues related to fertility, pregnancy rates,
and live births in persons with SCI. Question 2 focuses on
issues related to male impotence post SCI.
- Question 1. Reproductive health: What is the current fertility rate for men and women after SCI?
- Are fertility rates changed by freezing a new patient's sperm?
- Are there better fertility rates using electroejaculation or vibration? Does order of method influence outcome?
- To improve fertility rates, when should invasive techniques such as testicular biopsy or aspiration or intracytoplasmic sperm injection (ICSI) be pursued?
- Are there pregnancy complications and prospective obstetric management issues for SCI females?
- Question 2. Male sexuality: How has the availability of Viagra® and other remediation affected sexual function, frequency of activity, and adjustment after SCI?
- Is Viagra® really more benign than intracavernous injections?
- How does the morbidity of prostaglandin injections compare to the older (less expensive) papaverine?
- What is the morbidity of vacuum tumescence devices?
- What indications, if any, remain for implantable penile prosthetic devices?
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Methods
A Technical Expert Panel (TEP) consisting of six members
was convened to provide advisory support to the project,
including refining the questions and highlighting key variables
requiring consideration in the evidence synthesis.
Study Identification
Building on a preliminary search strategy conducted by UOEPC
in the feasibility task order, a comprehensive updated
search for citations was conducted using six databases
(MEDLINE®, PreMEDLINE®, CINAHL®, Cochrane
Central Register of Controlled Trials, SocioFile, and
PsycINFO). Following the suggestions of the TEP, additional
published literature was sought through searches of relevant
associations' proceedings for the years 1997-2002. In addition,
industry was contacted for ongoing and/or unpublished data. A
final set of 2,128 unique references was identified and posted to
the UO-EPC's Internet-based software system for review.
Eligibility Criteria
Studies were considered relevant if they described both male
and/or female (adult or adolescent) populations with SCI,
involved any type of study design; published or unpublished,
and reported in English. Studies were also eligible for inclusion
if each met predetermined criteria. In reproductive health,
design criteria consisted of whether the study
- Discussed a fertility intervention.
- Included a pre and post intervention for fertility rates.
- Contained an original report of a measure of fertility rates in males, females, or both.
- Reported an original intervention trial after SCI.
Eligible interventions
included physical, surgical, laboratory techniques, or
prescription medications. Eligible fertility outcomes included:
- Pregnancies.
- Live birth rates.
- Sperm motility.
- Successful sperm harvesting.
- Ejaculations.
- Sperm count.
- Percent viable sperm.
- Hormonal.
- Ovulation rates.
- Cycle function.
- Other measures of sperm morphology.
- Volume of ejaculation.
In male sexuality, design criteria consisted of whether the
study reported an original intervention trial or series with a pre-
and post measure for sexual dysfunction after SCI, contained
an original report of a measure of sexual dysfunction, or
whether the article discussed an intervention for sexual
dysfunction. Eligible interventions included:
- Cognitive/behavioral.
- Prescription medications.
- Surgical or hormonal interventions.
Eligible outcomes included:
- Psychological outcomes (e.g., validated sexual function questionnaire for males and/or females, structured interviews with qualitative analysis, educational component, global efficiency, or patient logs).
- Physiologic outcomes (e.g., penile and/or clitoral engorgement, endocrine, ultrasound testing of testicular size).
As an extension of the phase I feasibility study, two reviewers
were employed at the relevance assessment phase of the
evidence review. Two levels of screening for relevance were used,
with the first level directed at bibliographic records during phase I, the feasibility study (i.e., title, authors, key words,
abstract), and the second level focused on those "full report"
articles retrieved based on the results of the first level of
screening. Screenings for relevance, assessments of study quality,
and data abstraction were completed using the UO-EPC's
review management Internet-based software, which resides on a
secure Web site.
Calibration exercises preceded each step of the screening
process. Excluded studies were noted as to the reason for their
ineligibility using a modified QUOROM format.24 Reports
were not masked given the equivocal evidence regarding the
benefits of this practice.25,26 Disagreements were resolved by
forced consensus and, if necessary, by a third party.
Data Abstraction
Following a calibration exercise, two reviewers independently
abstracted the contents of each included study using an
electronic data abstraction form developed especially for this
review. Once reviewers completed their work, all work was
checked by their counterparts. Data abstracted included the
characteristics of the following:
- Report (e.g., publication status, language of publication, year of publication).
- Study (e.g., sample size, research design, number of arms).
- Population (e.g., age, percent males, diagnosis description).
- Intervention/exposure (e.g., Viagra® for sexual function, testicular biopsy for fertility rates).
- Withdrawals and dropouts.
Study Quality
In this report, study quality was assessed through
examination of each individual report rated independently by
two assessors. Quality was defined as the confidence that the
study's design, conduct, analysis, and presentation has
minimized or avoided biases in any comparisons.27 Several
approaches exist to assess quality: components, checklists, and
scales. Therefore, a combination of methods was used in an
effort to ascertain a measure of reported quality across different
study designs.
For RCTs the Jadad scale was used. This is a validated scale
consisting of three items that assesses the methods used to
generate random assignments, double blinding, and a
description of dropouts and withdrawals by intervention
group.28 The scoring ranges from one to five, with higher
scoring indicating higher quality. In addition, allocation
concealment (i.e., keeping the randomization blind until the
point of allocating participants to an intervention group) was
assessed as adequate, inadequate, or unclear.29 An a priori
threshold scheme was used for sensitivity analysis: a Jadad total
score of < 2 indicates low quality with scores < 2 indicating
higher quality.
Cohort and case-control study reports were assessed using
the Newcastle-Ottawa scale (NOS).30 The NOS is an ongoing
collaboration between the Universities of Newcastle, Australia,
and Ottawa, Canada. It was developed to assess the quality of
nonrandomized studies with its design, content, and ease-of-use
directed to the task of incorporating the quality assessments in
the interpretation of meta-analytic results.
Qualitative Data Synthesis
A qualitative synthesis was completed for all studies included
in the evidence report. A description is provided of the progress
of each citation through the review process, and includes
information pertaining to each report, such as their sample size.
The qualitative synthesis was performed on a question-specific
basis, with studies grouped according to research design (e.g.,
RCTs, observational studies). Each synthesis includes a
narrative summary of the key defining features of the study
report, if stated, (e.g., a priori description of inclusion/exclusion
criteria), population (e.g., diagnosis-related),
intervention/exposure (e.g., use of Viagra®), outcomes, study
quality, applicability, and individual study results. A brief study-by-study overview typically precedes a qualitative synthesis.
Quantitative Data Synthesis
For several of the questions investigated in this evidence
report, quantitative data synthesis was deemed appropriate.
However, most of the studies were non-comparative case series
and outcomes were in the form of single proportions (e.g.,
proportion of couples achieving at least one pregnancy).
Current meta-analytic methodology generally focuses on data
from studies that include a control group, such as randomized
controlled trials. From a meta-analytic perspective, one of the
strengths of studies that include control groups is that even if
there is some degree of heterogeneity in characteristics such as
population or intervention across studies, there may be little
statistical heterogeneity in the contrast between outcomes in
the treatment and control groups across studies. This protection
against heterogeneity is not available in studies without a
control group. Judicious selection of comparable studies for
inclusion in a meta-analysis of single proportions therefore
becomes especially crucial. In the present work, heterogeneity
of single proportions was assessed using Pearson's chi-square
test. P-values less than 0.10 were taken to indicate statistically
significant heterogeneity. Forest plots were constructed using
Wilson score confidence intervals around individual study
proportions.31 Pooled estimates and their confidence intervals
were obtained using the random effects estimator of Laird and
Mosteller.32
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Results
Literature Search
A total of 2,420 bibliographic records were retrieved through
database searches. After duplicate records were removed, 2,082
unique items remained. An additional 46 potentially relevant
studies were identified through conference abstracts or were
nominated by manufacturers. Therefore, a total of 2,128
reports were evaluated against the eligibility criteria and after
the initial screening for relevance, 1,627 records were excluded.
Although the majority of the initial screening was performed in
the phase I feasibility study, the additional studies that were
identified when the search was "rerun" at the beginning of this
study (n=98, of which 47 were duplicates) were screened
according to phase I criteria. The reasons for exclusion were:
not relevant to SCI (n=530); not relevant to sexuality or
reproductive health (n=410); case report or opinion piece (n =
282); no relevant measure reported (n=271); not relevant to
any of the questions (n=78); and, report pertaining to
adolescent or child only (n=6). The remaining 501 reports
were then retrieved and subjected to a more detailed relevance
assessment. Two hundred and forty-five of these reports dealt
with issues relating to fertility and 289 of the reports examined
sexual dysfunction. After further relevance assessment, 180 of
the 246 reports on fertility and 232 of the 289 reports on
sexual dysfunction failed to meet the inclusion criteria of phase
II. In total, 122 reports were deemed relevant for the systematic
review—66 of the reports examined fertility and 56 reports
examined sexual dysfunction in individuals with SCI.
Study Results
The 122 studies included 6,668 individuals, ranging in age
from 16 years to 81 years, of which 78 percent of the studies
enrolled only men, with 6 percent reporting all female
participation.* As might be expected, the complete spectrum of
SCI severity was included across the studies. Eighty-seven
studies (71 percent) reported on the level of lesion, however,
only 18 (15 percent) reported on American Spinal Injury
Association level. However, final classifications of data on
severity of SCI injuries are complicated in this review due to
inconsistencies in the reporting of severity of injury. The
majority of studies included in this review used a noncomparative
study design (61 percent) to address the question
under consideration. For example, a group of males might be
given a specific intervention to improve ejaculation rates.
Typically, the authors did not select a comparator group and
only reported specific outcomes on this group. Few RCTs exist
to evaluate the efficacy of male sexual dysfunction and the
majority of those are duplicate publications, perhaps giving the
impression of being more broadly evaluated than one might
think on first impressions.
The quality of reporting of the 122
studies included here is less than optimal. For example, of the
75 non-comparative studies, none of them reported on all the
quality items we used to evaluate their reports. The highest
number of quality criteria met was 16/19 items, and this was
achieved by only one (1 percent) of the 75 studies.33
* "Couples" were counted as a single case pertaining to number of
participants enrolled. Fourteen percent of the included studies reported on
the enrollment of couples only or couples together with single-case male
participants.
Question 1. What Is the Current Fertility Rate for Men and
Women After SCI?
Fertility in Females After SCI
There were no studies found that investigated this
question.
Fertility in Males After SCI
Ejaculation Rates. Different aspects of male infertility have
been studied. Reports in the literature on this topic can be
grouped, and some information pooled. Much of the earlier
work in this area centers on interventions to aid males with SCI
to ejaculate, either during sexual activities with their partners or
in a clinic situation to harvest semen for implantation.
Different authors and clinics have chosen different
methodologies to aid ejaculation in males with SCI. They
include intrathecal or subcutaneous physostigmine with
masturbation, penile vibration techniques with or without
pharmacologic enhancement, or electroejaculation.
Ejaculation rates results from 22 studies that used vibration
and/or electrode stimulation in males with SCI. Overall, these
interventions resulted in an overall ejaculation response rate of
86 percent (random effects pooled estimate: 0.86, 95% C.I.
0.80, 0.93). When data from studies examining vibration
and/or electrode stimulation to provoke ejaculation are pooled,
a large degree of heterogeneity is observed. This observation
reflects the inclusion of early studies that were aimed at
establishing optimal parameters for the technique (e.g.,
vibration amplitude, electricity parameters), as well as the
inclusion of more recent studies which implemented the now
common practice of first starting with vibration and later
including electroejaculation to increase success rates.
Pregnancies and Live Births. Not all authors chose to present
both pregnancy and live birth data. However, there is no
suggestion in the literature that the spontaneous abortion rate
of a pregnancy conceived from an SCI male exceeds that of the
general population; therefore, we chose to combine both sets of
data. These results represent the number of couples who have
achieved at least one pregnancy or live birth over the number of
couples who tried to conceive.
It is very important to note that
some authors reported their fertility rates after very simple
procedures such as vibration or electrode ejaculation, whereas
some studies were performed in clinics that greatly increased
the odds of achieving pregnancy by adding a variety of
advanced fertility techniques. Data from the 17 studies
documenting pregnancy rates were pooled and indicate
pregnancy rates of 51 percent (random effects pooled estimate:
0.51, 95% C.I. 0.42, 0.60). Data from the 13 studies
documenting live-birth rates were pooled and indicate live birth
rates of 40 percent (random effects pooled estimate: 0.40, 95%
C.I. 0.33, 0.48). The heterogeneity of these pooled results is
explained by the addition of advanced fertility techniques that
increase the success rates for these endeavors by up to four
times, compared with insemination alone.
Are fertility rates changed after freezing a new patient's
sperm?
There is little data to support the practice of freezing the
sperm of SCI males after 16 days post-injury, and that even the
advantages of early freezing (within the first 2 weeks) is
outweighed by the loss of sperm motility during the procedure,
since with modern techniques one is virtually certain of
obtaining fresh sperm from the SCI male when he is ready to
conceive a child in later years.
Are there better fertility rates using electroejaculation or
vibration? Does order of method influence outcome?
We were unable to locate any documents demonstrating a
superior fertility outcome between vibration and
electroejaculation. Therefore, we compared the side-effect
profile of the two procedures to determine risk-benefit. Of the
21 studies identified that reported ejaculation rates with
technique, 10 reported adverse events.34-43 Often, authors
combined procedures, although they did not always separate
the side effects by procedure. However, papers that combined
the procedures demonstrated that the vibration technique is less
likely to be successful for lower motor neuron (areflexic)
injuries than with spastic injuries, and electroejaculation is
more likely than vibration to cause autonomic dysreflexia in
patients with spastic injuries.35,37 Electroejaculation also has the
added side effects of inflammation to the rectal mucosa39 and
stimulation pain34,38,39,44 in incompletely injured patients.
Therefore, most clinics that combine these techniques usually
try vibration first followed by electroejaculation in the areflexic
subjects that tend to not respond to vibration alone.
To improve fertility rates, when should invasive techniques
such as testicular biopsy or intracytoplasmic sperm injection
be used?
Invasive techniques to enhance fertility (advanced fertility
[AF] techniques) such as in vitro fertilization and ICSI have
been used more in recent studies. By grouping the 18 studies
above that reported either pregnancies or live births according
to whether they used or did not use AF techniques, one can
assess how using AF techniques impacts fertility rates. In doing
so, one easily observes that to achieve pregnancy and birth rates
approaching 50 percent or greater SCI couples need to use an
AF technique. Testicular biopsy or vas aspirations should be
reserved for those patients who cannot achieve sperm
harvesting or whose harvested sperm by the above techniques is
of very low quality. ICSI can greatly enhance success in those
individuals whose sperm quality is insufficient for intrauterine
insemination.
Are there pregnancy complications and prospective
obstetric management issues for SCI females?
We did not find any reports that provided the necessary data
for us to project the number and frequency of complications
and other obstetric issues in females with SCI. There are
numerous case reports, however, without the larger sample size
obtained with a case-series study, it is difficult to conduct
further research or inform practice or policy regarding this
important health issue.
Question 2. How Has the Availability of Viagra® and Other
Remediation Affected Sexual Dysfunction and Adjustment
After SCI?
Interventions for Female Sexual Dysfunction
We found six articles that used a case-control design5,45-49 and
one article that used a RCT design50 to examine the
phenomena of sexual arousal in response to physical and
cognitive stimulation in women with SCI.
Male Sexual Dysfunction
Most of the literature discusses male erectile dysfunction
after SCI. Aside from a number of RCTs evaluating Viagra®,
all of the studies that we identified which addressed this topic
were case-series studies.
The most common problems faced
when trying to analyze this literature is that many authors
chose different outcome measures. For example, some authors
use a validated erectile grading system such as Schramek's,
whereas others used their own grading system; some authors
used all or parts of the International Index of Erectile Function
(IIEF) sexual satisfaction rating scale, whereas others designed
their own scales. When authors use either an on/off grading
system or a common question on the IIEF, we have pooled the
data when appropriate. Interventions discussed in this review
include: behavioral interventions, topical medications,
intraurethral alprostadil, intracavernous injections, vacuum
tumescence devices, penile implants, sacral stimulators, and
Viagra® (sildafenil).
Is Viagra® really more benign than intracavernous
injections?
Intracavernous injections have a significantly higher efficacy
than Viagra® (90 percent versus 79 percent). To compare the
side-effect profile of intracavernous injections with that of
Viagra®, we extracted data from the studies described above
that reported side effects. It can be noted that careful dosage
adjustment is necessary with the papaverine or papaverine/phentolamine combinations. When used alone, prostaglandin
E1 has few side effects outside of its cost.
If subjects are reliable
and if they have little sensation there seems to be few
advantages of Viagra® over intracavernous injections aside from
subject and partner preference. Although other
phosphodiesterase inhibitors have come to market since
sildanefil, no SCI treatment data for these drugs were available
at the time of this review.
How does the morbidity of prostaglandin injections
compare with the older, less expensive papaverine or
phentolamine?
Although similar in efficacy, prostaglandin E1 is less stable at
room temperature and much more expensive than papaverine
or phentolamine. Proponents cite a shorter half-life (less chance
of priapism) and less injection-site pain and scarring as reasons
to use this substance despite its expense. We identified six
noncomparative case-series studies51-56 and one RCT57 that
reported the numbers of side effects. Although the efficacy of
these two treatments is similar, priapism and discomfort are
reported more frequently with papaverine.
What is the morbidity of vacuum tumescence devices?
When used with proper clinic instruction and according to
the specifications of the manufacturers, these devices have a
very low morbidity rate with no irreversible morbidities noted.
Although there are case reports of penile ischemia in the
literature, these case reports serve only as a warning not to leave
the device on too long and cannot help us with ascertaining a
complication rate.
What indications, if any, remain for implantable penile
prosthetic devices?
It is notable that although penile implants result in a high
level of satisfaction for those clients who do not have
complications, the serious complication rate is as high as 10
percent. Furthermore, patients who have an implant removed
are no longer candidates for other treatment options as they are
likely to have damage to the penile tissues that would make
them nonresponsive to intracavernous injections or vacuum
devices. Very few patients will not respond to any of the more
benign techniques.
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Availability of Full Report
The full evidence report from which this summary was taken
was prepared for the Agency for Healthcare Research and
Quality (AHRQ) by the University of Ottawa Evidence-based
Practice Center, Ottawa, Canada, under Contract No. 290-02-0021. Print copies may be obtained free of charge from the AHRQ Publications Clearinghouse by calling 800-358-9295.
Requesters should ask for Evidence Report/Technology
Assessment No. 109, Sexuality and Reproductive Health Following Spinal Cord Injury.
The Evidence Report is also online on the National Library of Medicine Bookshelf, or can be downloaded as a PDF File (3 MB). PDF Help.
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Return to Contents
AHRQ Publication Number 05-E003-1
Current as of December 2004
Internet Citation:
DeForge D, Blackmer J, Moher D, et al. Sexuality and Reproductive Health Following Spinal Cord Injury. Summary, Evidence Report/Technology Assessment: Number 109. AHRQ Publication Number 05-E003-1, December 2004. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/epcsums/sexlspsum.htm