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ORIGINAL RESEARCH & REVIEWS

A Systematic Review of Pelvic Floor Muscle Training for Erectile


Dysfunction After Prostatectomy and Recommendations to Guide
Further Research
Calvin Wong, MPT,1 Dennis R. Louie, MScPT,2 and Cheryl Beach, PhD1

ABSTRACT

Background: Erectile dysfunction is one potential complication after radical prostatectomy; often pelvic floor
muscle training is offered as an intervention to improve quality of life and erectile function post-operatively.
Aim: To provide a summary of current evidence regarding the effectiveness of pelvic floor muscle training in the
management of erectile dysfunction after radical prostatectomy and provide recommendations for future research.
Methods: An electronic search was conducted for relevant research studies using PubMed, EMBASE, CINAHL,
Medline, and PEDro. Quality of selected trials was assessed by 2 independent reviewers using the Modified
Downs and Black Checklist; disagreements were resolved by consensus.
Main Outcome Measure: The main outcome measure is the International Index of Erectile function (IIEF-5).
Results: 9 studies of various study design were included in this review. Most studies demonstrated improve-
ments in erectile dysfunction with pelvic floor muscle training; however, lack of methodological rigor for several
studies and variability among training protocols limited interpretation of results.
Clinical Implications: Further well powered and rigorously designed randomized controlled trials are needed to
investigate the effect of pelvic floor muscle training on erectile dysfunction after radical prostatectomy.
Strengths & Limitations: This review employed a systematic method of appraising the available evidence for
pelvic floor muscle training for erectile dysfunction after radical prostatectomy. Limited high-quality articles were
identified and few conclusions could be drawn from the existing evidence.
Conclusion: Future high-quality randomized controlled trials should include strategies to improve adherence to
exercise, clearly describe exercise protocols, and integrate new evidence for verbal cues and biofeedback for
muscles involved in erection. Wong C, Louie DR, Beach C. A Systematic Review of Pelvic Floor Muscle
Training for Erectile Dysfunction After Prostatectomy and Recommendations to Guide Further Research.
J Sex Med 2020;XX:XXXeXXX.
Copyright  2020, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.
Key Words: Prostatectomy; Pelvic Floor; Erectile Dysfunction; Physiotherapy; Sexual Dysfunction; Rehabilitation

INTRODUCTION AND BACKGROUND Reported prevalence rates of ED in men after RP are approxi-
Radical prostatectomy (RP) is often performed in men who mately 85%.3,4 There are many well-documented psychological,
are diagnosed with prostate cancer to remove cancerous prostate social, and emotional consequences for men who experience ED.
tissue. One potential complication of this procedure is erectile Depression and anxiety are commonly reported after prostatec-
dysfunction (ED), which is defined as the inability to achieve and tomy and are associated with uncertainty regarding recovery of
maintain an erection for satisfactory sexual performance.1,2 sexual function and notions of diminished masculinity.5
Furthermore, men report challenges with intimacy in partnered
and sexual relationships.5 Such findings highlight the importance
Received September 15, 2019. Accepted January 4, 2020. of addressing ED in this population as it can have profound long-
1
Rehabilitation Science Online Programs, University of British Columbia term impacts on quality of life.
(UBC), Vancouver, BC, Canada;
2
Graduate Program in Rehabilitation Studies, University of British Columbia
(UBC), Vancouver, BC, Canada
Physiology of Erection and Function of the Pelvic
Copyright ª 2020, International Society for Sexual Medicine. Published by
Floor in Erection
Elsevier Inc. All rights reserved. According to Dean and Lue,6 normal penile erection requires
https://doi.org/10.1016/j.jsxm.2020.01.008 optimal neural and vascular function, and it can be described in

J Sex Med 2020;-:1e12 1


2 Wong et al

2 phases—arterial dilation and venous occlusion. During sexual either prostatectomy or transurethral resection of the prostate for
stimulation, the parasympathetic cavernous nerves (supplied by both ED and climacturia.18 The authors pooled results from 2
the sympathetic chain ganglia T11-L2) cause smooth muscle studies in a meta-analysis and found limited evidence for enhanced
relaxation of the corpora carvernosa and the corpus spongio- outcomes for ED using PFMT with biofeedback. The authors
sum.6 This relaxation allows increased blood flow via the excluded studies comparing active interventions using ES, as well
accessory branches of the pudendal artery that run through the as quasi-experimental studies.
penile smooth muscle. This blood flow causes enlargement of The present review will include randomized, controlled trials,
sinusoids within the corpora cavernosa and, to a lesser extent, including those comparing active interventions, and quasi-
the corpus spongiosum which surrounds the urethra. As pres- experimental studies to provide a comprehensive overview of
sure continues to increase, venous occlusion occurs which helps the existing evidence surrounding ED after RP. A thorough
maintain erection. During erection, the bulbospongiosus and investigation of methodological quality will be presented to
ischiocavernosus muscles contract and increase penile pressure. ensure that differences in the quality of study design are
Strong contraction of these muscles during intercourse can accounted for during the synthesis of data. The aim of this review
drive more blood flow into the penis and further increase penile was to answer the following question: Among men who have
pressure during erection.7 It has been suggested by Dorey7 that undergone RP, does PFMT alone or in combination with other
training the pelvic floor muscles may be valuable in rehabili- treatment techniques improve erectile function? A second aim of
tation because it may directly augment these mechanisms of the review was to describe the current state of evidence regarding
penile erection. Contraction of the ischiocavernosus muscle has PFMT for post-RP ED and describe considerations for future
been reported to increase intracavernosal pressure and reduce research.
venous return during erection. Bulbospongiosus contraction
drives blood to the distal (glans) penis and compresses the
dorsal penile vein to further prevent venous backflow resulting METHODS
in augmented erection.
Search Strategy
The review was conducted following the Preferred Reporting
Pathophysiology of ED After Prostatectomy
Items for Systematic Reviews and Meta-Analyses
In nerve-sparing RP, there may be trauma to the periprostatic
(PRISMA) guidelines and the protocol was registered with the
neurovascular bundle resulting in neuropraxia.8 There may also
International Register of Systematic Reviews (PROSPER-
be vascular injury to the accessory pudendal arteries with a
OeCRD42019128146). The flow of studies through the review
subsequent loss of oxygenated blood flow to the penile soft tis-
process as well as the 5 electronic databases (PubMed, EMBASE,
sue. This may result in apoptosis of penile smooth muscle,
CINAHL, Medline, and PEDro) that were searched for English
impaired venous occlusion, and penile tissue fibrosis.1,8,9
language articles from inception to November 2019 can be found
Conventional penile rehabilitation programs commonly in Figure 1. The following keywords were combined for the search:
include medications, such as phosphodiesterase 5 inhibitors and (prostatectomy OR post prostatectomy OR radical prostatectomy)
prostaglandin E1, as well as vacuum erection devices. These in- AND (erectile dysfunction OR sexual dysfunction OR impotence)
terventions are widely considered to be safe and effective for ED AND (pelvic floor muscle training OR pelvic floor exercise OR
after RP.10 However, a recent Cochrane review concluded that pelvic floor rehabilitation OR physiotherapy OR physical therapy
current evidence does not support the use of these forms of penile OR pelvi-perineal exercise). A search for relevant ongoing trials
rehabilitation to restore erectile function.1 Owing to the persistent was performed through clinicaltrials.gov using the search terms
nature of ED after prostatectomy, it is pertinent to identify alter- “erectile dysfunction” and “pelvic floor muscle training” with the
nate conservative interventions to improve outcomes. Although limitation to trials with male subjects. In addition, reference lists
general exercise is recommended, current clinical practice guide- from selected articles were hand searched for trials relevant to the
lines for the management of ED do not make any recommenda- review.
tions relating to pelvic floor muscle training (PFMT),11e14 which
The inclusion criteria are as follows:
has been used in the rehabilitation of urinary incontinence post-
prostatectomy. It has been reported that PMFT has a role in the  Clinical trials including randominzed controlled trials (RCT’s)
management of ED.7,15 Systematic reviews of conventional penile and quasi-experimental designs
rehabilitation have suggested that PFMT with and without  Interventions include PFMT preoperatively or postoperatively
biofeedback or electrical stimulation (ES) can enhance outcomes  Target men who underwent RP
when ED is caused by venous leakage.16,17 As such, it is important  Studies with a primary aim of measuring ED postoperatively
to investigate the state of the literature regarding this exercise- using any validated outcome measure
based intervention. To date, only one review has investigated the  Study language in English
efficacy of physiotherapy interventions, including PMFT, after  Published in a peer-reviewed journal

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PFMT for ED After RP 3

Figure 1. PRISMA flow diagram. PRISMA ¼ Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Figure 1 is available in
color online at www.jsm.jsexmed.org.

The exclusion criteria are as follows: Data Synthesis


 ED occurring in populations other than in those that under- Data from the selected studies were extracted by one reviewer
(C.W.) and recorded in table format. There was significant
went RP
 Not a full-text article (eg, conference abstract) heterogeneity in study design and treatment protocols amongst
studies which did not allow for meta-analysis of data from the
studies.
Procedure
The lead author performed the search using the established
search strategy. Article titles and abstracts were screened sepa- Methodological Quality
rately by 2 authors (C.W., D.R.L.) to ensure objectivity, and 2 reviewers (C.W. and D.R.L.) independently appraised the
full-text articles were then screened separately to identify those methodological quality of the 8 selected studies using the Modi-
that met the inclusion criteria. Discrepancies were resolved fied Downs and Black checklist, which has been developed to
through discussion between authors (C.W. and D.R.L.). The appraise studies involving public health interventions. It has been
third author (C.B.) was available for arbitration in the case of reported to have acceptable validity and inter-rater reliability.19
unresolved disagreements. The data that were extracted included Studies selected were rated on 5 subscales within the checklist:
the following: study design, study date, study population, au- reporting, external validity, internal For validity—bias, internal
thors names, number of participants, details of intervention, validity—confounding, and power. Any disagreements between
results of the intervention, and outcome measures taken. reviewers were resolved through discussion and consensus.

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Table 1. Summary of study characteristics

4
Outcome measures†
Study authors Sample population Sample Study Duration Pelvic floor [outcome at trial
and date (surgical approach) size design of study Intervention assessment end point]

Fode et al Postradical 83 RCT 12 months PFMT with penile vibratory No reported assessment IIEF-5 [not effective]
201524 prostatectomy stimulation device daily at procedure
(surgical approach not home program.
specified)
Geraerts et al Radical prostatectomy 33 RCT 6 months Therapist supervised PFMT with Did not report an IIEF-EF, VAS
201525 (open and ES 1 time per week for assessment procedure. [effective]
laparoscopic) 6 weeks; 1 time every
2 weeks for next 6 weeks.
Home program 60
contractions split between 2
sessions per day.
Glazener et al Radical prostatectomy 411* RCT 12 months Therapist instruction on Digital rectal examination ICSmale, ICSsex
201122 (laparoscopic, perineal, performing 3 MVC held up to assessing ability to questionnaire [not
and retropubic) 10 s, performed in various attain “strong anal effective]
positions, 2 times per day. squeeze” rated on a
Given written instructions to 0 to 6 scale.
review at home.
Encouraged to contract pelvic
floor muscles during sexual
activity.
Karlsen et al Radical prostatectomy 7 couples Single-arm trial 12 months Group or individual PFMT with Digital rectal IIEF-15 [effective]
201726 (retropubic, robot physiotherapist and sexual examination of one
assisted laparoscopic) health counseling with nurse voluntary contraction
practitioner.
Laurienzo et al Radical prostatectomy 123 RCT 6 months a. Home exercise group: bridge, Digital perinometer with IIEF-5, perinometer
201827 (surgical approach not adductor squeeze, pelvic floor rectal balloon, average recordings [not
specified) contractions 2-3 times per of 3 maximal muscle effective]
day for 6 months. contractions recorded.
b. ES group: same home
program and anal electro-
stim with physiotherapist 2
time per week for 7 weeks.
Lin et al 201221 Radical prostatectomy 72 RCT 12 months PFMT: 3  10sec MVC, 2 times Digital rectal IIEF-5 [effective]
(open and per day in various positions examination
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laparoscopic) and given PFMT DVD for


home practice.
Sighinolfi et al Radical Prostatectomy 3 Case Series 3 months PFMT with ES, 90 contractions Digital rectal examination, IIEF-EF [effective]
200928 (Surgical approach not per day with EMG using an with instructions to

Wong et al
specified) anal probe. tighten and lift pelvic
floor muscles as if to
stop the flow of urine.
(continued)
PFMT for ED After RP 5

RESULTS

DVD ¼ digital video disc; EMG ¼ electromyography; ES ¼ electrical stimulation; IIEF ¼ International Index Erectile of Function; MVC ¼ maximal voluntary contraction; PFMT ¼ pelvic floor muscle training;
Outcome measures†
[outcome at trial Descriptive Summary of Studies Selected for Data

IIEF-5 [effective]

IIEF-5 [effective]
Extraction
A search of the selected databases returned 223 articles for
end point]

screening. 55 articles were removed as duplicates, and 146 arti-


cles were excluded based on inclusion and exclusion criteria. 22
articles were reviewed for eligibility, and 13 were excluded with
reasons listed in Figure 1.

assessment procedure.
Methodological quality of the studies was generally fair with 2
studies rated “good,” 4 studies rated as “fair,” and 3 studies rated
measuring MVC

Did not report an


as “poor” quality. Quality categories for the Black and Downs
Pressure probe
assessment

checklist have been previously described in the literature and can


Pelvic floor

be found in Appendix 3.20 Studies generally scored lower on the


external validity, internal validity—bias, internal val-
idity—confounding, and power subscales. A scoring legend for
the Black and Downs checklist can be found in Appendix 2.
Physiotherapist led PFMT using

contractions and 3 sustained


PFMT using anal pressure

strength and endurance


consecutive sessions of

EMG biofeedback (anal

contractions and home

Reporting Subscale
probe biofeedback for
10 therapists supervised

probe), 3  10 rapid
training days before

The results of the studies rated on the 10-item reporting


subscale of the Modified Downs and Black checklist are sum-
prostatectomy.

marized in Appendix 1. All 9 studies fulfilled 4 items of the


Intervention

subscale (described the hypothesis, outcomes, patient character-


program

istics, and patients were lost to follow-up). Only one study


adequately reported on adverse events. 8 of 9 studies received an
overall reporting score of 6 or higher, and 2 of those received a
score of 10. The mean total score for the subscale was 7.67
Not defined

12 months

(SD ¼ 1.83) with a range of 5-10.


Duration
of study

External Validity
Overall scores on the external validity subscale were poor. A
summary of scores is shown in Appendix 1. 3 of the studies failed
to provide enough information to make a determination
regarding any items in the subscale. Only one study reported that
design
Study

*Only subjects recruited to the Radical Prostatectomy trial were included.


RCT

RCT

they ensured their recruited sample was representative of the


population. 5 studies had intervention conditions that were
RCT ¼ randominzed controlled trials; VAS ¼ visual analogue scale.

similar in context (ie, staff, facilities) to the representative pop-


Sample

ulation. There was a mean score of 1.11 (SD ¼ 0.99) with a


size

Only measures related to erectile function are reported.


52

52

range between 0 and 3.

Internal Validity—Bias
Radical prostatectomy

Radical prostatectomy

Most studies (89%) did not explicitly describe an attempt


(surgical approach)
Sample population

to blind participants to the intervention. Blinding of exam-


(retropubic)

iners taking outcome measures was also generally not


described with only 3 studies fulfilling the criteria; studies not
(open)

fulfilling this criterion either did not provide adequate infor-


mation to make a judgment or did not attempt to blind ex-
aminers. Compliance with the intervention was high at 89%;
Table 1. Continued

however, misclassifications in trials that biased results toward


Study authors

the null hypothesis were considered to have fulfilled this cri-


Perez et al

Prota et al
201829

201223
and date

terion. Generally, there was poor reporting of adherence


measures of compliance with at-home PFMT programs which
may represent a limitation in many of the studies reviewed.

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6
Table 2. Summary of scores on the Black and Downs checklist and study quality assessment
Total quality
score
Internal (<14 ¼ poor,
External Internal validity— 15-19 ¼ fair, Suitability of study to assess effectiveness
Author, year Reporting validity validity—bias confounding Power >20 ¼ good) of intervention* (greatest/Moderate/Least)

Fode et al 9/11 1/3 5/7 4/6 0/1 19/28 Greatest: concurrent comparison group with pre- and post-measure of
201524 exposure by phone interviews and outcome measures.
Geraerts et al 9/11 0/3 5/7 3/6 1/1 18/28 Moderate: concurrent comparison groups and pre- and post-IIEF-EF
201525 measures, but no reported measures of adherence to exposure (ie,
at-home PFMT program) reported
Glazener et al 10/11 3/3 6/7 5/6 1/1 25/28 Greatest: concurrent comparison group with pre- and post-measure of
201122 at-home PFMT by self-report and outcome measures.
Karlsen et al 6/11 1/3 1/7 2/6 0/1 10/28 Least: no concurrent comparison group
201726
Laurienzo et al 5/11 2/3 4/7 4/6 0/1 15/28 Moderate: concurrent comparison group with preoutcome
201827 postoutcome measures but no measure of adherence to at-home
PFMT reported
Lin et al 201221 10/11 1/3 5/7 5/6 1/1 22/28 Greatest: concurrent comparison group with pre- and post-measures
of at-home PFMT by scheduled phone calls and outcome measures.
Sighinolfi et al 6/11 0/3 2/7 1/6 0/1 9/28 Least: no comparison group, single pre- post-measurements.
200928
Perez et al 8/11 0/3 3/7 1/6 0/1 12/28 Greatest: concurrent comparison group and prospective measurement
201829 of exposure and outcome.
Prota et al 6/11 2/3 5/7 5/6 0/1 18/28 Moderate: concurrent comparison group with preoutcome and
201223 postoutcome measures, written instructions provided but no
measure of adherence to at-home PFMT reported.
*Criteria for defining suitability can be found in Appendix 3.
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Wong et al
PFMT for ED After RP 7

The mean score on the internal validity subscale was 4.00 therapist-supervised PFMT supported by ES for 3 months in
(SD ¼ 1.56) with a range of 1e6, results can be found in combination with a PFMT home program yielded an
Appendix 1. improvement in postoperative IIEF-EF mean scores of 4.1 for
the treatment group and e0.2 for the control group
(P ¼ 0.025).25 In a third study,27 a home PFMT program was
Internal Validity—Confounding
compared with PFMT with ES applied via anal electrode. At
More than half of the studies failed to meet internal validity
6-month follow-up, there was an improvement in the IIEF-5
criteria for 3 items on the subscale (recruitment of patients from
score across all groups, and no significant difference in
the same population, concealment of group randomization from
improvement between groups was reported.27
experimenters, and adequate adjustment for confounding in data
analysis). Most studies (67%) reported that they recruited sub-
jects into intervention groups over the same time period, and PFMT and Penile Vibratory Stimulation
88% reported that they accounted for losses to follow-up in their Penile vibratory stimulation (PVS) has been reported to in-
data analysis. The mean score on the internal val- crease pressure to the external urethral sphincter and has been
idity—confounding subscale was 3.33 (SD ¼ 1.56) with a range used to induce ejaculation in a group of men with injured spinal
of 1e5. cord, and when applied to the perineum, it has been used to treat
female urinary incontinence.24 In the group of men who un-
Power derwent RP, authors self-selected a cutoff point of 18 on the
3 studies reported they were adequately powered based on IIEF-5 as inclusion criteria to their study.24 PVS applied to the
their calculations.21e23 One study23 reported a power calculation frenulum 10 times in 10-second increments in conjunction with
requiring 30 subjects per group; however, they were only able to PFMT was used 1 week preoperatively and for 6 weeks after
recruit 26 subjects each to the intervention and control group. surgery. Authors reported a trend toward improvement in out-
Most studies did not include power calculation. comes with their intervention but did not reach statistical sig-
nificance (P ¼ 0.07).24 The authors suggested that a longer
intervention period may have resulted in greater changes in IIEF-
Pelvic Floor Muscle Assessment 5 scores. Minor self-limiting side effects of PVS including pain,
There was significant variation in the method of pelvic floor redness, and bleeding were reported with PVS use.
muscle assessment used in each study (Table 1). Methods of
assessment included digital rectal examination21,22,26,28 and
digital anal perinometer,27 and 3 did not report a specific method PFMT with Biofeedback
of assessment.23,24,25 2 studies included ES in combination with For the purposes of PFMT, biofeedback has been used to
PFMT and neither found that ES was effective for improving ED improve a subject's awareness of pelvic floor muscle contraction
in the post-RP population.25,27 to promote accurate performance of prescribed exercises. One
study examined the effect of PFMT with biofeedback using an
anal electromyography (EMG) electrode once per week for
PFMT Protocols 12 weeks.23 The authors reported a significantly shorter time to
There was significant heterogeneity in the content and
recovery of potency (defined here as an IIEF-5 score of 20)
reporting of PFMT protocols in the selected studies (Table 1).
among the intervention group in their study (P ¼ 0.032). At 12
Training protocols differed on instructions calling for maximal
months postoperatively, 47.1% of men in the intervention group
voluntary contraction or submaximal contractions and varied
were considered potent compared with 12.5% in the control
between 3 and 90 repetitions, with contractions held up to 10 s,
group.23 2 studies using the same Men After Prostate Surgery
practiced 1e2 times per week or once every 2 weeks. Various
exercise protocol used biofeedback by verbal confirmation from
levels of supervision by experimenters or therapists (typically
study examiners through digital rectal exam.21,22 Both studies
physiotherapists or nurses) were used, and in one instance, an
used biofeedback for skill acquisition during the first 2 in-person
instructional PFMT digital video disc was provided to facilitate
sessions. One of these studies continued to provide biofeedback
at-home practice.
by digital rectal examination to inform subjects of exercise per-
formance, and some subjects in the intervention group also
PFMT and ES received biofeedback by anal probe EMG based on availability
3 studies used ES in combination with PFMT with in- and therapist discretion.22 This study compared mean scores on
terventions beginning at 12 months after RP to study men with the ICSmale questionnaire between the intervention and control
persistent ED symptoms.25,27,28 However, one was of low groups and found no statistically significant change between
methodological quality and least suitable for assessing effec- groups at follow-up time points.22 The other study found a
tiveness of PFMT with ES.28 The other was an RCT with fair statistically significant difference in IIEF-5 scores at 12-month
methodology and moderate suitability for assessing interven- follow-up for the intervention group as compared with the
tion effectiveness. The authors of this study found using controls (P < 0.05).21

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8 Wong et al

Preoperative PFMT 15),30 the abridged 5-item (IIEF-5)31 version, or the erectile
Although preoperative PFMT has been assessed in the urinary function domain (IIEF-EF)32 was used in all but one study to
incontinence literature, only one study was identified for PFMT measure change in ED. Minimal clinically important differences
for ED after RP.29 This study used an anal pressure probe to (MCIDs) assist in meaningful interpretation of change in
provide the patient with visual biofeedback about the timing and outcome measures.33 The anchor-based MCID for the IIEF-EF
strength of muscle contractions administered during 10 consecu- has been previously defined as a change of 4 (sensitivity: 0.74,
tive preoperative PFMT sessions with a physiotherapist in the days specificity: 0.73).32 Furthermore, previous studies have reported
preceding open prostatectomy. A biofeedback program used to a cutoff score of 21 to classify ED in the IIEF-5 and a score of 25
assess maximal voluntary contraction and training for maximal for the IIEF-15.30,31 A grading scale for the IIEF-5 has been
and submaximal endurance contractions was implemented in the defined by authors and separates ED into the following cate-
10 training sessions. Preoperative and postoperative IIEF-5 scores gories: severe, moderate, mild to moderate, mild, and no ED.31
were compared, and statistically significant differences were noted Other outcome measures used included a visual analogue scale of
in the intervention compared with control groups (P < 0.001). erectile quality rated on hardness, length, tumescence, elevation,
and persistence25 and the ICSmale and ICSsex questionnaires.22
Methodological Quality and Suitability to Assess The ICSmale questionnaire has been shown to have good psy-
Intervention Effectiveness chometric validity and reliability and has been shown to be able
Of the 7 RCTs included in this review, only 4 possessed the to detect change in male urology patients who have received
attributes for the greatest suitability to assess the effectiveness of interventions including prostatectomy.34 Most studies reported
PFMT on post-ED outcomes (Table 2).21,22,24,29 Of these 4 outcomes as mean changes between baseline and selected time
studies, 2 had the strongest methodological quality among points and commented on whether changes were statistically
reviewed studies. One of these studies reported PFMT was significant. It is important to recognize that meaningful change
effective, and the other reported no difference compared with based on MCID or defined cutoff points are not always equiv-
usual care.21,22 The remaining 2 had fair24 and poor29 meth- alent to statistically significant change. Only 4 studies clearly
odological quality and reported that PFMT was effective and defined meaningful categories based on predetermined cutoffs or
improving ED outcomes. The other RCTs were of fair meth- MCIDs for the selected outcome measures.16,17,22,29 Future
odological quality and had moderate suitability to assess PFMT studies should clearly report the psychometric validity and reli-
effectiveness on ED outcomes.23,25,27 All of these studies re- ability of their chosen outcome measures and clearly define
ported effective outcomes at trial end points. The 2 least suitable MCIDs where available.
studies also represent the poorest methodological quality and
reported effective outcomes on ED which underscores the need DISCUSSION
to reduce risk of bias in future studies reporting on this topic.
While ED is widely known to occur in men who underwent
RP, there have been few high-quality clinical trials investigating
Follow-up Period the efficacy of PFMT as a conservative treatment in this popu-
Most studies had follow-up periods within the first 12 months lation. Most studies selected for review had methodological
after prostatectomy,21e24,26,27 and 2 had recruitment after limitations in study design, treatment protocol, and information
1 year.25,28 Most studies had 3e4 outcome evaluations during reporting.
the follow-up period. One study had a follow-up evaluation at 3
months after recruitment to the study.25
Effectiveness of PFMT for Post-RP ED
3 RCTs identified in this review had either fair or strong
Sample Population methodological quality and the greatest suitability to assess the
Most studies included sample populations with both open and effectiveness of PFMT on post-RP ED.21,22,24 Results of these
laparoscopic RP procedures, with the exception of one trial that studies were mixed. Of note, 2 of these RCTs used the Men
included laparoscopic, open, and perineal surgical approaches.22 After Prostate Surgery protocol to inform PFMT protocols,
4 studies did not report the type of RP included in their trial yielding differing results.21,22 There was only a trend toward
populations.24,27e29 Most studies included both nerve-sparing significant improvement in ED outcomes identified in a study
and nonenerve-sparing procedures and noted that there were using PVS; however, the intervention was only given for
no differences in randomization into control and intervention 2 months.24 3 RCTs had fair methodological quality and mod-
groups. 3 studies recruited only participants who had nerve- erate suitability to judge PFMT effectiveness. 2 of these studies
sparing procedures.24,28,29 used ES in conjunction with PFMT25,27 but had notably
different exercise protocols and showed opposing impact on ED
Outcome Measures outcomes. One study used EMG biofeedback and showed sig-
The present review included trials using validated outcome nificant change in outcomes.23 One study showed good effect of
measures related to erectile function. The 15-item IIEF (IIEF- preoperative PFMT on post-RP ED IIEF-5 scores (P < 0.001);

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PFMT for ED After RP 9

however, there was poor reporting of blinding, randomization, penile erection.6,7,35,36 Although many of the selected studies
and recruitment and allocation of subjects to intervention and make note of this relationship, the method most commonly
control groups which impacts external and internal validity and selected to assess pelvic floor muscle recruitment was digital rectal
may put this study as risk of selection bias.29 Overall, the evi- examination, which is regarded as a measure of puborectalis
dence from RCTs does not allow adequate comparisons between function.21,22,28 Similarly, studies used EMG biofeedback with
trials, and varying results limit conclusions that can be drawn anal probes, which most closely reflects puborectalis recruitment.
regarding the effectiveness of PFMT on post-RP ED. It is Future studies may need to match assessment and biofeedback
important to note that in most RCTs, the control group received techniques to the muscles thought to be involved in erectile
usual care that typically included a form of written instruction or function. Real-time ultrasound imaging can provide visual
alternative version of pelvic floor exercise because withholding feedback of recruitment of specific male periurethral structures
postoperative care was considered unethical. including bulbospongiosus.37,38 Interobserver and intraobserver
reliability have been demonstrated (P > 0.05) for real-time ul-
Quasi-Experimental Study Design trasound as a measure of endurance and maximal pelvic floor
One study used a case-series design to investigate the effect of contractions in supine and standing postures after RP.39 Future
PFMT in combination with EMG biofeedback and ES of the studies may consider ultrasound as biofeedback for pelvic floor
pelvic floor muscles.28 Although the authors were able to show exercise prescription related to muscular endurance and strength
improvement in their subjects, without a control group inter- in supine and functional standing positions in post-RP ED.
pretation of their results is limited. Another study investigated a In general, there was inconsistent reporting of the instructions
combination of PFMT and couples' counseling relating to in- given to participants recruited to trials to elicit preferred pelvic
timacy, communication, and sexual health concepts.26 Previous floor muscle contractions. It has been suggested that recruitment
literature has suggested that men with organic causes of ED may of the male pelvic floor is different, given specific verbal cues.40
also have psychosomatic overlay related to performance anxiety Urethral closure has been suggested to be important for urinary
and the accompanying stress that this produces.5,7 Although no incontinence retraining in men.41,42 Furthermore, there has been
meaningful conclusions can be drawn from the single-arm trial discussion regarding the necessary focus of pelvic floor cues
included in this review, it highlights the multidisciplinary nature emphasizing urethral closure for urinary incontinence training
of ED after RP which may require the consideration of intimacy, contrary to conventional training protocols often used in post-
sexual communication, and sexual health education in combi- prostatectomy rehabilitation trials.43 It is currently unknown
nation with PFMT. There is a need for further study with trials whether similar specific cueing may be necessary for ED recovery
that identify the impact of the psychological overlay that are after RP; however, future trials may consider reporting the spe-
present as part of ED. At present, there is no conclusive evidence cific exercise instructions used in their methodology to bring
describing the impact of PFMT with counseling for ED after RP. clarity to this question.

Information Reporting and Treatment Protocols Exercise Dosage


The studies included in this review generally had the lowest
Of the studies reviewed, there was inconsistent reporting of
scores on the external validity, and internal validity bias, and
exercise dosage (repetitions, frequency, and intensity). Trials
confounding subscales. To improve external validity, future
tended to use a combination of maximal and submaximal con-
studies should clearly report measures taken to ensure a repre-
tractions. Repetitions ranged from 3 sustained holds to 90 rep-
sentative sample population. Internal validity scores were affected
etitions 2-3times per day. Future trials should ensure that
by poor reporting of blinding measures for examiners taking
exercise protocols are clearly described to identify the purpose of
outcome measures, for concealment of randomization from ex-
the exercises (proprioception, motor control, hypertrophy) and
perimenters, and adjusting for confounding in data analysis.
an evidence base supporting the exercise prescription.
Improved reporting of these measures may help improve internal
validity in future studies. Studies were also generally under-
powered, and most studies failed to provide a power calculation. Adherence to Exercise
Clear and comprehensive descriptions of exercise protocols and Difficulty with patient adherence to pelvic floor exercise
use of valid and reliable outcome measures may improve programs is a common occurrence and has been acknowledged in
comparability between studies and improve ability for future the literature.44 Of the 9 studies included in the current review,
reviews to combine data for meta-analysis. all but 3 studies failed to describe an explicit strategy to ensure
adherence to prescribed exercise.21,22,24 One of these studies
reported adherence to prescribed daily PFMT fell to 37% in the
METHOD OF ASSESSMENT FOR PELVIC FLOOR intervention group and 27% in the control group at 12-month
MUSCLES follow-up.22 It has been suggested that factors contributing to
It has been reported that both the ischiocavernosus and bul- low adherence include forgetting to perform the exercises and
bospongiosus muscles are involved in producing and maintaining low motivation.45 As such, reminder aids including exercise

J Sex Med 2020;-:1e12


10 Wong et al

calendars, personal electronic device alarms, and scheduled STATEMENT OF AUTHORSHIP


follow-up appointments have been recommended to improve
Category 1
adherence to PFMT programs.45,46, One study described
(a) Conception and Design
teaching participants' family members about pelvic floor muscle
Calvin Wong; Cheryl Beach
exercises.21 The authors suggested that family members perform (b) Acquisition of Data
exercise with participants and remind them to complete their Calvin Wong
exercises. Follow-up phone calls24 and information booklets with (c) Analysis and Interpretation of Data
written instructions22 were other methods used to remind par- Calvin Wong; Cheryl Beach; Dennis R Louie
ticipants to complete PFMT exercises.
Category 2
(a) Drafting the Article
Limitations Calvin Wong
The present study only included trials published in English. (b) Revising It for Intellectual Content
There were several studies identified that were pertinent to the re- Cheryl Beach; Dennis R Louie
view that were published in other languages but were not included. Category 3
Articles relating to the topic of PFMT and sexual health are some-
(a) Final Approval of the Completed Article
times published in nursing journal databases such as EBSCO and Cheryl Beach
SCOPUS, which were not included in the current review, and it is
possible that relevant studies were missed. The general paucity of
available evidence limits the strength of conclusions that can be REFERENCES
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Supplementary data related to this article can be found at
urinary incontinence. Neurourol Urodyn 2018;37:1120-1127. https://doi.org/10.1016/j.jsxm.2020.01.008.

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