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Sexual Function and Quality of Life in Women with Urinary
Incontinence Treated by a Complete Pelvic Floor Rehabilitation
Program (Biofeedback, Functional Electrical Stimulation, Pelvic
Floor Muscles Exercises, and Vaginal Cones)jsm_16761.9

Massimo Rivalta, MD, Maria Chiara Sighinolfi, MD, Salvatore Micali, MD, Stefano De Stefani, MD, andGiampaolo Bianchi, MD Urology Department, University of Modena and Reggio Emilia, Modena, Italy A B S T R A C T
Introduction. Urinary incontinence (UI) is a debilitating condition that can cause discomfort, embarrassment, loss
of confidence; it can lead to withdrawal from social life, and adversely affects physical and mental health, sexual
function and quality of life (QoL) in women.
Aim. The aim is to determine the impact of combined pelvic floor rehabilitation (PFR) on UI, female sexual
dysfunction, and QoL.
Main Outcome Measures. Female Sexual Function Index questionnaire (FSFI) and King's Health Questionnaire
Methods. Sixteen patients with UI were selected and underwent a complete PFR program (biofeedback, functional
electrical stimulation, pelvic floor muscles exercises, and vaginal cones). Patient filled out the FSFI questionnaire and
the KHQ at the baseline and at follow-up.
Results. After PFR none of the patients reported urine leakage during sexual activity. Resolution of incontinence was
achieved in 13 (81.25%) women. Only three (18.75%) patients had positive 1-hour pad test after the treatment.
There was significant difference between pad test leakage before and after the PFR (P < 0.001).
The mean Stamey incontinence score was 1.37 ⫾ 0.5 at the baseline vs. 0.25 ⫾ 0.57 at the follow up (P < 0.001).
Before PFR, FSFI total score ranged from 25.8 to 2 (mean 14.65 ⫾ 6.88), after treatment the FSFI total score ranged
from 36 to 2 (mean 22.65 ⫾ 9.5) (P < 0.001). The improvement of the scores in the six FSFI domains, 5 months after
the conclusion of PFR, was statistically significant (desire, arousal, lubrication, orgasm, satisfaction, and pain). All the
nine domains in the KHQ presented a low average score after treatment and the improvements were statistically
Conclusions. PFR led to a significant difference in the daily use of pads, 1-hour pad test, and Stamey incontinence
scores. The treatment caused an improvement in patient's QoL index and sexual function. Rivalta M, Sighinolfi
MC, Micali S, De Stefani S, and Bianchi G. Sexual function and quality of life in women with urinary
incontinence treated by a complete pelvic floor rehabilitation program (biofeedback, functional electrical
stimulation, pelvic floor muscles exercises, and vaginal cones). J Sex Med **;**:**–**.

Key Words. Urinary Incontinence; Pelvic Floor Rehabilitation; Sexual Function; Quality of Life
Pelvic floor rehabilitation should be considered as first-line-therapy, as it is a minimally invasive procedure andeffective, without precluding surgery in case of failure. A U rinary incontinence (UI) is a very common condition, especially in women, and affects complete rehabilitation program can provide a beneficial almost all aspects of everyday life, influencing not effect on sexual function and quality of life.
only affected individuals but also their families.
2010 International Society for Sexual Medicine J Sex Med **;**:**–** Rivalta et al. The prevalence of UI increases with age, with a Inclusion and exclusion criteria typical rate in young adults ranging from 20% to Inclusion criteria 30%, reaching from 30% to 40% around middle Women older than 18 years of age age, with a further steady increase in older age No associated neurological diseaseStress urinary incontinence (prevalence: 30–50%) [1]. Stress urinary inconti- Exclusion criteria nence (SUI) is the most common type of UI and it Detrusor overactivity is defined as any involuntary leakage of urine Reduced cistometric capacity and/or bladder compliancePrevious surgical treatment for stress urinary incontinence related to any abdominal effort such as coughing Cystocele, rectocele, uterine prolapse of degree II or higher or sneezing [2]. It is estimated that 49% of the Current or recurrent vulvovaginitis women with symptoms of incontinence present Current or recurrent urinary tract infections SUI [3]. Increased life expectancy, particularly in PregnancyPace Maker women, has led to an increasing incidence of UI.
UI interferes in social, physical, psychological, andsexual aspects, adversely affecting self-esteem andquality of life (QoL). Health problems, bad sleep, three female patients affected by sexual dysfunc- economic impair, sexual dysfunction, uncomfort- able interpersonal relationships, and decreased The purpose of this study is to evaluate the self-confidence can cause social exclusion and psy- effects of the combined and complete rehabilita- chological problems [4,5].
tive treatment of SUI, through 1-hour pad test, Conservative treatment based on pelvic floor Stamey incontinence score, the FSFI, and the muscle exercises to restore the support of the king's Health Questionnaire (KHQ).
pelvic organs and the urethral closing mechanismis becoming an important therapeutic option for Materials and Methods
the treatment of SUI. Pelvic floor rehabilitation(PFR) should be considered as first-line therapy This is a prospective study conducted from (according to U.S. Department of Health and December 2007 to March 2009. The treatment Social Services Clinical Guidelines Panel and was offered to patients with clinical history of SUI according to European Association of Urology during medical consultation. For a total of 30 [EAU] Urological Guidelines), as it is a minimally patients that underwent consultation during this invasive as well as effective procedure, which does period, 12 did not meet the inclusion criteria not preclude surgery in case of failure [6].
(Table 1) and 2 refused the treatment modality A complete PFR treatment program usually because of difficulties to take part in the session at includes the following: biofeedback (BFB), func- the hospital once a week.
tional electrical stimulation (FES), pelvic floor The average age of the patients was 48.5 years muscle exercises (PFME), and PFME using (range from 29 to 70 years). Pads were used by all vaginal cones (VC) [6,7].
the patients (mean of 1.3 pads per day). In the Female UI is frequently associated with sexual 56.2% of the patients there had been a previous dysfunction, and as a consequence, lower Female vaginal delivery, and mean parity was 1.33. The Sexual Function Index (FSFI) scores in clinical mean body mass index was 22.3 (range 17–30).
trials [8,9].
Five women (31.2%) reported "a little" urine An evaluation of sexual health among women leakage during sexual activity or intercourse who were affected by overactive bladder (OAB) (KHQ has a specific section for urinary symptoms, was recently carried out by Coyne and co-workers: which is not considered for global score, but allows whether associated or not with incontinence, OAB the patient to express the degree of impact of each results in an impairment of sexual function, desire, individual symptom on their life as "a little," and ability to achieve orgasm [10]. Urinary stress "moderately," or "a lot").
incontinence has been found to have a negative SUI was indicated by a full clinical examina- impact on the quality of the patient's sexual life, tion, including a complete history, standard uro- the patient experiencing frequent pain, and coital dynamic evaluation, urinalysis, urine culture, a incontinence during intercourse [5,11].
complete gynecologic examination, and a cough provocation test in the supine and standing posi- approach to this emerging aspect of incontinence: tion with a comfortably full bladder. Participants a preliminary experience with the use of combined in the study were free from any other gynecologic PFR techniques (BFB–FES–PFME–VC) in just disease such as uterine myoma, ovarian cyst, or J Sex Med **;**:**–** Rehabilitation, Sexual Function and Quality of Life advanced uterine or vaginal prolapsed. Only shape and volume but different in weight. Each patients in grade 0 and grade 1 according to the patient began exercising with the lightest cone Pelvic Organ Prolapsed-Quantification Scale retainable in the vagina for 1 minute; once the (POP-Q) were included in the study. The POP-Q cone can be retained easily for 10 minutes, the scale was used pretreatment as well as during patient started exercising with the next heaviest every follow-up visit. Urodynamic studies were cone. Before moving on to a heavier cone, it is performed according to the International Conti- advisable to check that the patient can retain the nence Society standards. Leak-point pressure cone when coughing, ascending and descending during Valsalva maneuver (VLPP) was measured.
stairs, and running.
VLPP was determined at 180 mL of bladder The patients were assisted by the same urologist filling. Intrinsic sphincter deficiency (ISD) was during the treatment. No patient (n 16) missed the defined as VLPP of ⱕ60 cm H2O. Postvoid residual volume was measured after spontaneous Patient filled out the FSFI questionnaire [14] micturition. The Stamey incontinence score and the KHQ [15] before the PFR and at (grade 0: continent; grade 1: loss of urine with follow-up (5 months after the conclusion of PFR).
sudden increases in abdominal pressure, cough- We evaluated each domain score.
ing, sneezing, laughing; grade 2: leaks with lesser The KHQ is a specific assessment instrument degrees of physical stress, such as walking, stand- of the QoL for women with UI [15], which con- ing erect from a sitting position, or sitting up in sists of 21 items distributed in nine dimensions: bed; grade 3: total incontinence, urine is lost general health, incontinence impact, role limita- without any relation to physical activity or posi- tions, personal limitations, social limitations, tion) was used for grading the severity of SUI personal relationship, emotions, sleep/energy, before and after the treatment [12].
severity measures. The score of each dimension A 1-hour pad weighing test, with standardized ranges from 0 (lower UI impact and therefore volume (200 mL of bladder filling), was performed better QoL) to 100 (higher impact, worse QoL).
in order to quantify the degree of UI and it was FSFI is a brief, self-report measure of female considered as positive when the weight was >2 g sexual function that evaluates six different domains: desire, arousal, lubrication, orgasm, sat- The patients underwent combined PFR (BFB– isfaction, and pain. It was first described by Rosen FES–PFME–VC) after signing an informed in 2000 [16] and is widely used for the assessment consent with prior verbal explanation of all the of female sexual function. The optimal cutoff steps of the procedure.
between normal and pathological values is set at The steps for a complete PFR program were 26.55 [14], which means sexual life is considered carried out as follows [7,8]: (i) FES for 20 minutes normal in the patients who scored >26.55, and once a week for a period of 3 months. Selected pathological in those who scored <26.55. The parameters included biphasic intermittent current cutoff scores to determine the presence of difficul- with the frequency set at 50 Hz, pulse width of ties on the six domains of the FSFI were obtained 300 ms, and an adjustable current intensity from published sources [14,17]; accordingly, (0–100 mA) to reach the tolerable intensity of scores smaller than: 4.28 on the desire domain, stimulation that did not cause pain in each indi- 5.08 on the arousal domain, 5.45 on the lubrica- vidual patient. "On time" ranged from 0.5 to 10 tion domain, 5.05 on the orgasm domain, 5.04 on seconds and "off time" ranged from 0 to 30 the satisfaction domain, and 5.51 on the pain seconds. (ii) BFB was conducted for 15 minutes, domain were used to classify participants as having once a week for a period of 3 months. (iii) PFME difficulties on that domain.
alone and (iv) PFME using VC were performed by The student's t-test was used for statistical the patient at home, after a preliminary training analysis, to compare pretreatment and post- with the urologist, accordingly to the Kegel pro- treatment data; statistical significance was set at tocol; this procedure requires at least 300 contrac- the 5% level (P value < 0.05).
tions of the pelvic floor muscle (PFM) a daydivided into six sessions, isolating PFM contrac-tions and eliminating co-activation synergies, alternating isotonic, and isometric exercises.
PFME were also performed using VC: three All the patients completed the scheduled program, plastic cones with a metal interior identical in and their compliance was verified through a J Sex Med **;**:**–** Rivalta et al. y
r d

Mean pads pretreatment Mean pads post-treatment n°pads per day pretreatment ° Pad 1,5
n°pads per day post-treatment Mean values
Figure 1 Pads usage per day before and after the treatment.
weekly visit. None of the patients reported side 0.3 ⫾ 0.7 in post-treatment, at 5 months after the effects as a result of the treatment.
conclusion of PFR (P < 0.001) (Figure 1).
After the combined rehabilitation program none of them reported urine leakage during sexual 1-Hour Pad Test (Figure 2) activity, including intercourse.
Mean urinary leakage at the 1-hour pad test beforethe rehabilitation was 19.93 g ⫾ 14.29 g, ranging Daily Use of Pads (Figure 1) from 52 g to 10 g. At the follow up, the mean Resolution of incontinence was achieved in 13 urinary leakage was 4.68 g ⫾ 12.03, ranging from (81.25%) women who were dry and did not 45 g to 0 g; only three (18.75%) patients had posi- require any use of pads; two (12.5%) patients tive 1-hour pad test (weight > 2 g) after the treat- improved (reduced their daily use of one pad), but ment (Figure 2). There was a significant difference had persistent stress incontinence. The mean pads between pad test leakage before and after the PFR per day utilize was 1.3 ⫾ 0.6 in pretreatment vs.
(P < 0.001).
Mean pad test pretreatment (gr) Mean pad tets post-treatment (gr) Pad test pretreatment (gr) Pad test post-treatment (gr) Mean pad test value (gr)
Figure 2 1-Hour pad test before and after the treatment.
J Sex Med **;**:**–** Rehabilitation, Sexual Function and Quality of Life Mean score
Figure 3 Stamey incontinence score before and after the treatment.
Stamey Score (Figure 3) total score ranged from 36 to 2 (mean 22.65 ⫾ 9.5) The Stamey incontinence score was used for (P < 0.001).
grading the severity of SUI. The mean score was The domain of desire improved significantly, 1.37 ⫾ 0.5 (range 1–2) at the baseline vs.
from 2.36 ⫾ 1.06 in the pretreatment to 3.86 ⫾ 0.25 ⫾ 0.57 (range 0–2) at the follow up (P < 1.62 in the post-treatment (P < 0.001); arousal 0.001). Thirteen (81.25%) patients were cured from 2.47 ⫾ 1.25 to 3.82 ⫾ 1.55 (P < 0.001); (grade 0—"continent"), two (12.5%) improved lubrication scores increased from 2.71 ⫾ 1.09 to (grade 1—"loss of urine with sudden increases 3.91 ⫾ 1.67 (P < 0.001); orgasm from 2.42 ⫾ 1.24 in abdominal pressure"), and one (6.25%) pati- to 3.8 ⫾ 1.62 (P < 0.001); satisfaction from 2.35 ⫾ ent had an unchanged incontinence score 1.12 to 3.75 ⫾ 1.53 (P < 0.001); and pain from (grade 2—"leaks with lesser degrees of physical 2.32 ⫾ 1.22 to 3.5 ⫾ 1.74 (P < 0.001) (values are mean values plus or minus standard error of themean). Figure 4 shows the results of the FSFIquestionnaire.
FSFI (Figure 4) The improvement of the six domains FSFI Before PFR, the FSFI total score ranged from 25.8 scores 5 months after the conclusion of PFR were to 2 (mean 14.65 ⫾ 6.88), after treatment the FSFI Scores - Mean values
Figure 4 Female
Index (FSFI) scores before and after the treatment.
J Sex Med **;**:**–** Rivalta et al. KHQ scores before and 5 months after the conclusion of pelvic floor rehabilitation 1. General health perception 2. Incontinence impact 3. Role limitations 4. Physical limitations 5. Social limitations 6. Personal relationships 9. Severity measures KHQ = King's Health Questionnaire.
KHQ (Table 2; Figure 5) activities and social encounters, and preparations Each KHQ domain obtained a score, and there- to minimize the potential for embarrassment from fore there was no general or total score for this incontinence episodes by wearing protective gar- questionnaire (Table 2) (Figure 5). The scores ments, using pads, and carrying a change of cloth- range from 0 to 100 and the higher the score, the ing. Daily activities including hobbies, household poorer the QoL. All the nine domains (general chores, and physical recreation are often scheduled health, incontinence impact, role limitations, around the location of toilets to avoid potentially physical limitations, social limitations, personal embarrassing situations. In spite of the impact SUI relationships, emotions, sleep/energy, and severity has on patients' lives, the condition often goes measures) in the KHQ presented a lower average unreported. Many individuals do not seek medical score after treatment and the improvements were help because they mistakenly believe that bladder statistically significant (Table 2).
control problems are an inevitable part of aging,that there is no treatment available, or they are tooembarrassed to discuss their problems with their healthcare provider [18].
UI has a profound impact on patients' lives. This The treatment of UI pursues not just the dis- debilitating, chronic condition can cause discom- ease's objective cure, but also an improvement in fort, embarrassment, and loss of confidence that QoL and sexual function [4,5].
can lead to withdrawal from social life, affect physical and mental health, and disrupt interper- common and multifaceted problem, associated sonal relationships. Patients often develop a with biological, sociocultural, medical, and inter- variety of coping behaviors and strategies [18].
personal factors [19]. Its incidence increases with These strategies can include the avoidance of age, and according to the most recent statistics, Mean scores 30
Figure 5 King's Health Questionnaire
Domain 1 Domain 2 Domain 3 Domain 4 Domain 5 Domain 6 Domain 7 Domain 8 Domain 9 (KHQ) scores before and after the J Sex Med **;**:**–** Rehabilitation, Sexual Function and Quality of Life affects 30–50% of women [8,9,19]. Female sexual- study, a complete rehabilitation can provide a ben- ity is adversely affected by UI in premenopausal, eficial effect on sexual function.
sexually active women: incontinent women report The effectiveness of a complete scheme, a higher prevalence of sexual dysfunction than together with the lack of side effects, makes it a those who do not suffer from incontinence [8].
suitable approach to sexual dysfunction associated Desire, lubrication, orgasm, and sexual satisfaction are the areas most affected by this problem [9].
The KHQ was chosen to verify the impact of This may be explained by the occurrence of therapies on QoL, which is increasingly relevant dermatitis caused by urine leakage, depression, and common in clinical research. International lit- and decreased libido, as a result of embarrassment erature reveals a consensus regarding the fact that and fear of UI during sexual activity, including urinary incontinence can adversely affect QoL intercourse [8].
in many aspects. The International Continence The role of FES in treating UI had been previ- Society has recommended that an assessment of ously investigated with regard to sexual dysfunc- QoL should be included in all clinical studies as a tion [8]. The authors suggest that electrical complement of objective data [24]. Robinson et al.
stimulation represents an important part of PFR.
[25] demonstrated that the impact on the QoL of However, according to Abrams [6], a complete patients with complaints of UI could be assessed rehabilitation program may include other compo- using a questionnaire. The KHQ is a health- nents such as BFB, PFME, and VC. Previously, in related QoL questionnaire that was originally a brief report, we had introduced a new approach developed and validated on women with urinary to this problem that consists of a combination of incontinence [15]. It has subsequently demon- different rehabilitative techniques for UI [7]. In strated consistent reliability, validity, and respon- the current study we confirm, on a more extended siveness among culturally diverse samples of men female population, that FSFI questionnaire is the and women, mostly with either stress or urgency best approach to assess all domains of female sexu- incontinence [18,26–29]. The KHQ has been ality. It represents a valid instrument that can be translated to numerous languages, and these applied to several diseases potentially affecting translations have generally been found to display sexuality, such as chronic pelvic pain and painful good psychometric properties [26,29,30]. The bladder syndrome [20]. In Paradiso Galatioto's KHQ has been used in numerous studies on a series, the FSFI, administered before and after clinically and demographically diverse range of FES, showed a significant improvement in desire, patients. Most commonly, it has been used to lubrication, sexual satisfaction, and pain, whereas evaluate pharmacological or surgical treatments arousal and orgasm domains were not significantly outcomes in patients with overactive bladder and affected. Our outcomes are consistent with the urinary incontinence, and it has consistently dem- ones previously noted, thus suggesting a remark- onstrated the ability to detect improvement in able enhancement in sexual health and satisfaction QoL [18,31–33]. It also been used as an anchor in in all the FSFI domains. This statement is particu- studies designed to validate other instruments larly evident for the desire, arousal, satisfaction, [34]. A six-item short form of the KHQ has been and orgasm domains.
found to have good internal consistency reliability The normalization of muscle tonus provided and sensitivity to change [35]. The KHQ was by PFR could be one of the possible explanations chosen for our study, particularly because of its of these outcomes [21]. As a result, rehabilitation extensive approach, easy comprehension, specific- represents the basis for satisfying orgasmic sen- ity, and applicability. To our knowledge, this study sation [22]. In fact, ischiocavernous attachment to represents the first application of KHQ in the the clitoral hood results in clitoral engorgement; assessment of a stress urinary incontinence com- the bulbocavernous muscle, when contracted, plete rehabilitative program (BFB–FES–PFME– places pressure on the deep dorsal vein of the VC). Previously Capelini MV et al. analyzed the clitoris, preventing venous escape [22]. Addition- influence of pelvic floor rehabilitation on KHQ ally, BFB–PFME can improve arousal, reducing domains, but simply with pelvic floor exercises the inhibition caused by leakage during orgasm and biofeedback for UI [4]. In this study the "General Health Perception" domain did not Complete PFR should consist in BFB, FES, demonstrate a significant variation.
PFME, and VC, as those steps act on multiple In our study, the complete treatment applied components of the pelvic floor. As reported in our demonstrated a significant improvement in QoL J Sex Med **;**:**–** Rivalta et al. as shown by the reduced scores obtained in all the (IVS-02) and transobturator (IVS-04) midurethral nine domains.
slings: Randomized trial. Eur Urol 2009;56:24–30.
2 Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A.
PFR according to the described protocol pro- The standardisation of terminology of lower urinary moted important difference in the daily use of tract function: Report from the Standardisation Sub pads, 1-hour pad test, and Stamey incontinence committee of the International Continence Society.
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ments in QoL index scores and sexual function, as 3 Hampel C, Wienhold D, Benken N, Eggersmann assessed by validated instruments. Moreover, after C, Thuroff JW. Prevalence and natural history of the combined rehabilitation program none of the female incontinence. Eur Urol 1997;32:3–12.
women reported urine leakage during sexual activ- 4 Capelini MV, Riccetto CL, Dambros M, Tamanini ity, including intercourse.
JT, Herrmann V, Muller V. Pelvic floor exerciseswith biofeedback for stress urinary incontinence. Int The learning process offered by the biofeed- Braz J Urol 2006;32:462–8.
back and training, followed by the stabilized of the 5 Oh SJ, Ku JH, Choo MS, Yun JM, Kim DY, Park exercises, even without supervision, may have WH. Health-related quality of life and sexual func- maintained the good results observed 5 months tion in women with stress urinary incontinence and after the supervised program of exercises were overactive bladder. Int J Urol 2008;15:62–7.
6 Abrams P, Khoury S, Wein A. Incontinence. 1st These positive results must be confirmed International Consultation on incontinence. Ply- throughout further studies with a larger number of mouth: Plymbridge Distributors Ltd; 2002.
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7 Rivalta M, Sighinolfi MC, De Stefani S, Micali S, Mofferdin A, Bianchi G. Biofeedback, electrical Corresponding Author: Massimo Rivalta, MD,
stimulation, pelvic floor muscle exercises, and Urology, University of Modena and Reggio Emilia, via vaginal cones: A combined rehabilitative approach del pozzo 71, Modena, Italy. Tel: 0039 059 4224766; for sexual dysfunction associated with urinary Fax: 0039 059 4224780; E-mail: incontinence. J Sex Med 2009;6:1674–7.
8 Paradiso Galatioto G, Pace G, Vicentini C. Sexual Conflict of Interest: None.
function in women with urinary incontinencetreated by pelvic floor transvaginal electrical stimu- Statement of Authorship
lation. J Sex Med 2007;4:702–7.
Category 1 9 Cohen BL, Barboglio P, Gousse A. The impact of (a) Conception and Design
lower urinary tract symptoms and urinary inconti- Massimo Rivalta; Giampaolo Bianchi nence on female sexual dysfunction using a validated (b) Acquisition of Data
instrument. J Sex Med 2008;5:1418–23.
Massimo Rivalta; Maria Chiara Sighinolfi; Salva- 10 Coyne KS, Margolis MK, Jumadilova Z, Bavendam T, Mueller E, Rogers R. Overactive bladder and (c) Analysis and Interpretation of Data
women's sexual health: What is the impact? J Sex Massimo Rivalta; Stefano De Stefani; Giampaolo Bianchi; Salvatore Micali 11 Espuña Pons M, Puig Clota M. Coital urinary incontinence: Impact on quality of life as measured Category 2 by the King's Health Questionnaire. Int Urogynecol (a) Drafting the Article
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Cite this article as: Richard M. Scheffler, Stephen P. Hinshaw, Sepideh Modrek and Peter Levine The Global Market For ADHD Medications , 26, no.2 (2007):450-457 Health Affairs The online version of this article, along with updated information and services, is For Reprints, Links & Permissions: is published monthly by Project HOPE at 7500 Old Georgetown Road, Suite 600,

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