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Analysis of a pilot program to implement physical therapy for women with gynecologic fistula in the Democratic Republic of Congo
International Journal of Gynecology and Obstetrics 127 (2014) 127–131
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Analysis of a pilot program to implement physical therapy for women with gynecologic fistula in the Democratic Republic of Congo Laura Keyser a,⁎, Jessica McKinney b, Chris Salmon c, Cathy Furaha d, Rogatien Kinsindja e, Nerys Benfield f a
Department of Physical Medicine and Rehabilitation, Johns Hopkins Hospital, Baltimore, MD, USA Center for Women’s Health, Marathon Physical Therapy, Newton, MA, USA Department of Industrial Engineering and Engineering Management, Western New England University, Springfield, MA, USA d Department of Obstetrics and Gynecology, HEAL Africa Hospital, Goma, Democratic Republic of Congo e Department of Obstetrics and Gynecology, Hôpital Charité Maternelle, Goma, Democratic Republic of Congo f Department of Obstetrics, Gynecology and Women’s Health, Albert Einstein College of Medicine, Bronx, NY, USA b c
a r t i c l e
i n f o
Article history: Received 14 December 2013 Received in revised form 8 May 2014 Accepted 20 June 2014 Keywords: Community-based rehabilitation Global health Gynecologic fistula Maternal morbidity Pelvic floor physical therapy
a b s t r a c t Objective: To describe components of a physical therapy pilot program for women with gynecologic fistula, and to report prospective data from the first 2 years of program implementation. Methods: A single-cohort observational study with repeated measures was conducted at HEAL Africa Hospital, Goma, Democratic Republic of Congo. Hospital staff received training in pelvic floor physical therapy. Guidelines for exercise, functional training, and reproductive health education were integrated into the existing program. Demographics, clinical findings, and functional outcomes were recorded. Key stakeholders were interviewed to understand the perceived strengths and limitations of the program. Results: A total of 205 women were followed up; 161 participated in physical therapy, with an average of 9.45 sessions. Of 161 women examined postoperatively, 102 (63.4%) reported no incontinence; they remained continent at discharge. Of 21 who indicated a change in level of incontinence during postoperative physical therapy, 15 (71.4%) improved. The program was feasible and well received by staff and patients. Conclusion: Pelvic floor physical therapy could have significant results in women with gynecologic fistula, may be an important adjunctive treatment in comprehensive fistula care, and warrants further investigation. © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction Gynecologic fistula is a devastating injury associated primarily with childbirth complications, resulting in an abnormal connection between the genital tract and the urinary or intestinal tracts, leading to the uncontrolled passage of urine and/or feces [1]. It is estimated that 3.5 million women and girls worldwide are living with untreated gynecologic fistula and that 50 000–130 000 new cases arise annually [2]. The most common cause of gynecologic fistula is obstructed labor. Delays, inefficiencies, and inequities in maternal health care contribute to a labor experience that may last for several days, during which time pressure of the presenting fetal part (typically the skull) on the soft tissue of the maternal reproductive tract leads to profound tissue damage, creating the fistula [2,3]. Iatrogenic and traumatic causes are less prevalent, being responsible for 17%–24% and 4%–6% of fistula cases, respectively [4–7]. Factors contributing to obstructed labor and gynecologic fistula are among the most extreme in the Democratic Republic of Congo (DRC), ⁎ Corresponding author at: Johns Hopkins Hospital, Dept. of Physical Medicine & Rehabilitation, Meyer 1-130, 600 N. Wolfe Street, Baltimore, MD 21287, USA. Tel.: +1 415 699 0984; fax: +1 508 285 7977. E-mail addresses: [email protected], [email protected] (L. Keyser).
a country with tolerance of sexual violence against women, persistent insecurity, a weak central government, and an insufficient health system [4–10]. The eastern region of the DRC has been affected by conflict for over two decades and lacks the infrastructure to adequately provide basic needs for the population, including access to health care for its poor and displaced population [8–10]. Women with gynecologic fistula live with a high burden of disease. They are vulnerable to myriad social and psychological effects including loss of income, loss of status in family or community, loss of self-esteem, depression, and in some cases divorce, complete social isolation, and forcible expulsion from their villages [2,11]. Comorbid physical burdens can include foot drop, joint contractures, and pain [12]. Surgery is the only cure for all but the smallest and most newly formed fistulas. Many governmental and non-governmental organizations have supported outreach, hospital-based fistula surgeries, and physician training in safe surgical techniques. Despite the success of many fistula surgeries, 16%–32% of women will continue to have incontinence even after successful fistula closure and an estimated 12%–31% will require more than one fistula repair in their lifetime [13–16]. Pelvic floor physical therapy has been demonstrated to be beneficial in treatment of incontinence and pelvic floor dysfunction; however, the
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literature exploring perioperative rehabilitation for women with gynecologic fistula is sparse [17]. One study of women with gynecologic fistula in Benin [18] indicated that pelvic floor physical therapy and health education had a positive impact on postoperative recovery, with lower rates of reported incontinence. Guidelines from WHO [19] and the International Federation of Gynecology and Obstetrics [20] include physical therapy as part of a comprehensive fistula program, yet offer little to support specific protocols or training guidelines for health professionals in the development and implementation of such services. The aim of the present study was to assess a physical therapy pilot program that was integrated into an existing fistula care program at a referral hospital in Goma, DRC, and to analyze prospective data regarding patient outcomes during the first 2 years of its implementation. 2. Materials and methods A single-cohort observational study with repeated measures was performed at the HEAL Africa Hospital, Goma, DRC. This hospital is a nonprofit, 160-bed tertiary care facility that serves a population of approximately 15 million as the primary referral center for North Kivu province. It also specializes in community education and public health. One major hospital-based program there provides medicosurgical management of gynecologic fistula, coupled with socioeconomic empowerment initiatives to assist women with fistula in postoperative community reintegration. Specialty-trained surgeons have performed 2000 fistula repairs since 2003, with an average of 300 surgeries annually during years when active conflict in the region did not limit daily hospital operations and surgeries performed during outreach missions [21]. Hospital staff requested education and training in pelvic floor physical therapy to optimize patient outcomes after repair. The resulting project was approved by the institutional review boards of the University of California San Francisco (San Francisco, CA, USA) and HEAL Africa Hospital. Participants provided verbal informed consent. Physical therapists based in the USA who had regional experience, as well as expertise in community-based rehabilitation and pelvic floor physical therapy, conducted a detailed needs assessment in March 2009 prior to launching a rehabilitation program in April 2009. Training was provided to medical staff at HEAL Africa Hospital between April 1, 2009 and August 15, 2010. An evidence-based training manual was compiled, translated into French, and distributed to two physiotherapists, the chief nurse managing postoperative fistula care, and physicians specializing in obstetrics, gynecology, and urogynecologic surgery. The manual addressed pelvic floor anatomy, physiology, and pathophysiology related to pregnancy and obstetric complications, particularly fistula and incontinence. It also included chapters on patient education, lifestyle modification, exercise prescription, and progression of functional activities, such as bed mobility, and the lifting and carrying of children or firewood. All staff working with patients with fistula attended a series of lectures. Two female physical therapists received further clinical training to perform and document a digital pelvic floor muscle assessment and to instruct patients on proper exercise techniques and functional activities. Interactive instructional sessions were developed and led jointly by nurses and physical therapists to teach patients about female reproductive anatomy, fistula, and preoperative and postoperative expectations. Patients were taught about continuation of pelvic muscle exercises after discharge, attention to body mechanics to avoid stress to the repaired tissues, access to family planning, and appropriate obstetric care for future pregnancies. Counselors were also present to provide psychological support. Box 1 provides details about the clinical pathways. Visiting clinicians from the USA remained on site to provide necessary logistical and clinical support until August 15, 2010. After this time, support was provided remotely via e-mail and during 1-month site visits in 2011, 2012, and 2013. Upon completion of physical therapy training and in collaboration with a US-based obstetrician/gynecologist and the Congolese fistula
Box 1 The clinical pathway for each patient with gynecologic fistula from hospital admission to discharge. Admission • Counselor intake o Orientation to services available o Psychosocial support • Preoperative medical examination o Characteristics of fistula o Symptoms o Comorbidities o Eligibility for surgery • Preoperative physical therapy examination and treatment o Abdominal and perineal tissue mobility and presence of scar tissue o Pain and sensitivity to palpation o Pelvic muscle strength and endurance o Level of continence o Functional mobility (ability to perform bed mobility, transfers, ambulation, squatting, lifting, and carrying loads) o Diaphragmatic breathing and pelvic muscle exercise/relaxation training • Surgical repair o Foley catheter placed for 14 days o Bed rest for 24–48 hours postsurgery • Postoperative nursing and physical therapy care—days 1–14 o Nurses mobilize patient; encourage out-of-bed activity with assistance if needed o Physical therapy in small groups or one-to-one; submaximal pelvic floor muscle exercises with the catheter still in place • Postoperative physical therapy examination and treatment— days 15+ o Repeat physical therapy assessment o Exercise/functional activity progression • Pelvic floor muscle exercises; goal of 10 repetitions, 10-second hold, 10-second relaxation Discharge • Coordinated breathing, abdominal, and pelvic muscle exercise progression while supine, on all fours, or standing; functional tasks • Bowel and bladder training, as needed: timed voiding, double or triple voiding, urge response, control, and suppression; lifestyle modifications (adequate water intake, avoidance of caffeine) • Interactive group session with nurse, physiotherapist, and counselor o Female reproductive anatomy; definition and causes of fistula; dispelling myths surrounding reproduction, childbirth, and fistula; pregnancy model for demonstration o Review of pelvic floor physical therapy exercises o Family planning education
team, a patient documentation form and corresponding database were created. Demographic and clinical information was collected, including information on medicosurgical treatment and physical therapy participation. Physical therapy outcome measures included manual pelvic floor muscle assessment as described by Laycock and Jerwood [22], which has demonstrated good validity for measuring strength (r = 0.786; P b 0.001) and endurance (r = 0.549; P b 0.001) when compared with perineometric evaluation, and high interexaminer and
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test–retest reliability. Level of continence was assessed before and after the intervention via self-report and was graded using the Addis Ababa Fistula Hospital Incontinence Scale. These measures are summarized in Box 2. Data were entered into an Epi-Info database (Centers for Disease Control and Prevention, Atlanta, GA, USA) between May 21, 2010 and April 23, 2012, and descriptive statistics were generated using Microsoft Excel (Microsoft Corporation, Redmond, WA, USA). Interviews with key stakeholders were conducted between June 12 and 28, 2013 to determine providers’ perceptions on the program’s success and limitations. Interview transcripts were then evaluated for themes. 3. Results A total of 205 patient charts were entered into the database. The mean age was 31 years (range 5–69) and nearly three-quarters of patients were illiterate (Table 1). Of 197 women for whom data on parity were available, 75 (38.1%) were primiparous. More than one-quarter of women had experienced sexual violence (Table 1). Most patients presented with vesicovaginal fistula; a smaller proportion had rectovaginal fistula or combined vesicovaginal and rectovaginal fistula (Table 2). More than one-fifth indicated that they had undergone fistula surgery previously (Table 2). The average length of time from development of fistula to treatment at HEAL Africa Hospital was 46 months (range 0–600); 65 (45.1%) of 144 women waited less than 1 year to seek treatment. Most fistulas resulted from obstetric complications, with the other fistulas resulting from trauma and iatrogenic causes (Table 2). Of the 205 patients, four-fifths cited urinary incontinence as a primary symptom and almost one-third described amenorrhea (Table 2). Although all patients were to receive preoperative physical therapy, in practice, physical therapy was only reliably integrated into postoperative care, formally commencing approximately 14 days after surgery with an internal pelvic muscle examination after the catheter was removed. Physical therapy records were available for 161 patients who received an initial postoperative physical therapy examination; a discharge evaluation was completed for 142 women. Patients participated
Box 2 Physical therapy outcome measurements. Strength: Modified Oxford Grading Scheme
Endurance Repetitions
Fast contractions
Addis Ababa Fistula Hospital Incontinence Scale [22]
0 Nil 1 Flicker 2 Weak 3 Moderate 4 Good 5 Strong Length of time contraction is sustained until the muscle fatigues Number of contractions performed at initial strength grade and endurance measured Number of 1-second maximal contractions performed in rapid succession 1 Cured; no incontinence 2 Incontinent with cough, strain, exertion 3 Incontinent while walking 4 Incontinent while walking, sitting, and/or lying, but voiding some urine 5 Incontinent while walking, sitting, and/or lying, but not voiding urine
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Table 1 Patient demographics and obstetric information relevant to fistula care at HEAL Africa Hospital.a Patient characteristics
Values
Age, y (n = 187) Height, cm (n = 85) Weight, kg (n = 147) Gravidity (n = 197) Parity (n = 197) Age at 1st delivery, y (n = 158) Education (n = 192) Illiterate Primary school Secondary school Marital status (n = 182) Single Married Widowed Divorced History of sexual violence (n = 184) Yes No
31 (5–69) 155 (140–190) 52 (16–76) 3.83 (0–13.00) 3.46 (0–12.00) 18 (12–43)
a
142 (74.0) 31 (16.1) 19 (9.9) 21 (11.5) 88 (48.4) 53 (29.1) 20 (11.0) 53 (28.8) 131 (71.2)
Values are given as mean (range) or number (percentage).
in an average of 9.45 postoperative sessions, with 128 (79.5%) having 7–14 days of therapy. Medical complexity (including age), technological issues that suspended data entry, service interruption due to insecurity and active armed conflict, and premature self-discharge are among the reasons for incomplete records and/or lack of participation in physical therapy. Fig. 1 illustrates postoperative and discharge values for physical therapy measures of strength and endurance. There were modest changes in strength and endurance of the pelvic floor muscles from the initial visit to discharge. Further investigation of the patients who demonstrated a change in one or more physical therapy outcome measures revealed some differences. A difference in manual muscle test grade from postsurgery to discharge was recorded for 25 (17.6%) of the 142 women who completed a discharge evaluation. Of those, 20 (80.0%) increased by one muscle grade, 2 (8.0%) by two muscle grades, and 3 (12.0%) decreased by one muscle grade. With regard to endurance, 74 (52.1%) women exhibited a difference, of whom 66 (89.2%) were able to hold a contraction for longer and 8 (10.8%) for a shorter period, with a range of –3 to +5 seconds difference. The number of repetitions of pelvic floor muscle contractions increased for
Table 2 Physician-reported preoperative examination findings for patients presenting with gynecologic fistula.a Characteristics of fistula Type (n = 170) VVF RVF Combined Other Cause (n = 186) Obstetric Traumatic Iatrogenic Time from onset to treatment, mo Primary symptoms (n = 205) Urinary incontinence Fecal incontinence Amenorrhea Pelvic pain Previous fistula surgery (n = 170) Fistula size, mm Abbreviations: RVF, rectovaginal fistula; VVF, vesicovaginal fistula. a Values are given as number (percentage) or mean (range).
Values 147 (86.5) 10 (5.9) 10 (5.9) 3 (1.8) 171 (91.9) 5 (2.7) 10 (5.4) 46 (0–600) 164 (80.0) 4 (2.0) 63 (30.7) 3 (1.5) 38 (22.4) 25 (1–120)
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Fig. 1. Results of the physical therapy examination of pelvic floor muscle strength from 14 days postsurgery to discharge. Mean scores are indicated for each measure.
129 (90.8%) women, with an average improvement of 3.1 repetitions (range 0–7). A change in the number of fast contractions of the pelvic floor muscles was detected in 35 (24.6%) women, of whom 31 (88.6%) showed an increase and 4 (11.4%) a decrease, with a range of –5 to + 6 change in contractions. Most women (102 [63.4%]) examined postoperatively scored 1 on the incontinence scale used, meaning they had no incontinence after surgical repair of the fistula; they remained continent at discharge from the hospital. Of 21 women who indicated a change in reported level of continence during the period of physical therapy, 15 (71.4%) improved and 6 (28.6%) worsened. The six patients who reported worsening incontinence all had an open fistula on postoperative examination. The expansion of HEAL Africa Hospital’s fistula program, including the addition of a physical therapy component, was well received by staff and patients. Immediately upon inception of the program, patients reported great value in both individual and group sessions, noting dramatically enhanced understanding of reproductive anatomy, pregnancy, and the relevance of lifestyle change and continued exercise after discharge. During interviews conducted in June 2013, physicians, nurses, and physical therapists involved in the trainings reported learning new information about pelvic floor muscle function and sources of dysfunction, and indicated that the information learned was helpful to their patients. Physicians reported that they regularly referred patients to physical therapy, and reflected positively on having a treatment option to address residual incontinence postoperatively.
4. Discussion The hospital and community-based rehabilitation program integrated at HEAL Africa Hospital aimed to address the pelvic health needs of women with fistula. The present study showed some improvements in pelvic floor functional capacity from even a brief exposure to pelvic floor physical therapy. The findings suggest that significant results could be obtained by addressing impairments common among this population. The program was feasible and well received by staff and patients. Despite having little background in pelvic floor physical therapy, the physical therapists at HEAL Africa Hospital learned to perform an internal pelvic muscle examination and record measurements related to strength and endurance. A positive trend for these outcome measures indicates that pelvic floor physical therapy may influence pelvic muscle strength and function for patients with gynecologic fistula. Functional outcomes (measured via level of incontinence) improved for 71.4% of patients who participated in physical therapy and demonstrated a change in status during this 2–3-week period. Although the program was well received by hospital staff, they also identified several limitations of the program. Both physicians and physical therapists reported needing more support in 2011–13 from the US clinician team in the form of continuing education and clinical skills training to improve capacity to diagnose and treat this patient population. Physicians cited administrative changes and staff turnover within
L. Keyser et al. / International Journal of Gynecology and Obstetrics 127 (2014) 127–131
the hospital and ongoing conflict and insecurity in the region as contributors to incomplete or missing patient charts and lapses in data entry. Both physicians and physical therapists expressed a desire to follow patients up for at least 6 months postoperatively to more accurately assess outcomes and to continue to provide pelvic health and family planning interventions. They cited funding as a major barrier to program continuation and success. Myriad influences on patient outcomes confound the data, and there are limitations of a single cohort observational study with repeated measures. Without a control group for comparison, it is not possible to know that it is definitively the physical therapy that has led to these improvements, as opposed to typical postoperative healing. As with many fistula care programs, long-term follow-up was not possible in the present study, and it is therefore not possible to report whether women continued to benefit from the program and how their levels of continence may have been affected over time. Most literature to support the use of pelvic floor physical therapy in treating urinary incontinence reports a treatment effect after 8–12 weeks [17]. Due to ongoing conflict and poor infrastructure in the region, there was no access to patients once they were discharged. This lack of long-term follow-up also means it is not possible to determine if a physical therapy program that emphasizes integrated pelvic floor function can protect the integrity of the original fistula repair and hence stave off the reported 11%–27% recurrence rate [15]. However, the positive data trend, along with patient and provider feedback, indicates that the addition of a physical therapy component to a comprehensive fistula care program benefits patients and may positively influence outcomes without adverse effects. Commitment of local providers and availability of visiting expert clinicians to provide direct on-site training were key to the program’s success. The hospital’s existing fistula program and experienced providers formed the framework that allowed physical therapy education and services to be integrated at various levels of care. The principles of community-based rehabilitation and health-systems strengthening support a two-fold approach: (1) enhance clinical skills by providing specialized pelvic floor physical therapy training to clinicians, and (2) change health behaviors and long-term patient outcomes through community-level education [23,24]. Future studies will evaluate treatment interventions and longerterm outcomes utilizing strong objective measures and appropriate sample sizes to facilitate statistical analysis. It is hoped that they will also assess the feasibility and utility of physical therapy to specifically address the problems of residual incontinence, recurrent gynecologic fistula, pelvic pain, and excessive vaginal scar tissue, which has been negatively associated with fistula surgery outcomes [25]. In conclusion, the present study describes the implementation and evaluation of an integrated program of physical therapy for women after surgical repair of gynecologic fistula. The results indicate that pelvic physical therapy may be an important adjunctive treatment for the comprehensive care of women with fistula and warrants further investigation. The model presented holds promise as a replicable program for other institutions that perform fistula repair, integrating the unique skill set of physical therapists into the optimal treatment of women with and recovering from gynecologic fistula. Acknowledgments This program was funded in part by Global Strategies and through a Tides Foundation grant awarded to HEAL Africa USA.
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Conflict of interest The authors have no conflicts of interest. References [1] Arrowsmith SD, Ruminjo J, Landry EG. Current practices in treatment of female genital fistula: a cross sectional study. BMC Pregnancy Childbirth 2010;10:73. [2] Wall LL. Obstetric vesicovaginal fistula as an international public-health problem. Lancet 2006;368(9542):1201–9. [3] Wall LL, Arrowsmith SD, Briggs ND, Browning A, Lassey A. The obstetric vesicovaginal fistula in the developing world. Obstet Gynecol Surv 2005;60(7 Suppl. 1):S3–S51. [4] Onsrud M, Sjøveian S, Mukwege D. Cesarean delivery-related fistulae in the Democratic Republic of Congo. Int J Gynecol Obstet 2011;114(1):10–4. [5] Sjoveian S. Gynecological fistula in the DR Congo. Master’s thesis Norway: University of Oslo; 2009. [6] Onsrud M, Sjøveian S, Luhiriri R, Mukwege D. Sexual violence-related fistulas in the Democratic Republic of Congo. Int J Gynecol Obstet 2008;103(3):265–9. [7] Benfield N, Kinsindja RM, Kimona C, Masoda M, Ndume J, Steinauer J. Fertility desires and the feasibility of contraception counseling among genital fistula patients in eastern Democratic Republic of the Congo. Int J Gynecol Obstet 2011;114(3): 265–7. [8] Van Herp M, Parqué V, Rackley E, Ford N. Mortality, violence and lack of access to healthcare in the Democratic Republic of Congo. Disasters 2003;27(2):141–53. [9] Coghlan B, Brennan RJ, Ngoy P, Dofara D, Otto B, Clements M, et al. Mortality in the Democratic Republic of Congo: a nationwide survey. Lancet 2006;367(9504): 44–51. [10] Human Rights Watch. The war within the war: Sexual violence against women and girls in eastern Congo. http://www.hrw.org/reports/2002/drc/. Published June 2002. Accessed November 15, 2013. [11] Mselle LT, Moland KM, Evjen-Olsen B, Mvungi A, Kohi TW. "I am nothing": experiences of loss among women suffering from severe birth injuries in Tanzania. BMC Womens Health 2011;11:49. [12] Arrowsmith S, Hamlin EC, Wall LL. Obstructed labor injury complex: obstetric fistula formation and the multifaceted morbidity of maternal birth trauma in the developing world. Obstet Gynecol Surv 1996;51(9):568–74. [13] Wall LL, Karshima JA, Kirschner C, Arrowsmith SD. The obstetric vesicovaginal fistula: characteristics of 899 patients from Jos, Nigeria. Am J Obstet Gynecol 2004;190(4): 1011–9. [14] Browning A. Risk factors for developing residual urinary incontinence after obstetric fistula repair. BJOG 2006;113(4):482–5. [15] Wall LL, Arrowsmith SD, Briggs ND, Browning A, Lassey A. The Obstetric Vesicovaginal Fistula in the Developing World. In: Abrams P, Cardozo L, Khoury S, Wein A, editors. Incontinence. 3rd ed. UK: International Continence Society, Health Publications Ltd.; 2005. p. 1403–54. [16] Sjøveian S, Vangen S, Mukwege D, Onsrud M. Surgical outcome of obstetric fistula: a retrospective analysis of 595 patients. Acta Obstet Gynecol Scand 2011;90(7): 753–60. [17] Hay-Smith EJ, Herderschee R, Dumoulin C, Herbison GP. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev 2011;12:CD009508. [18] Castille YJ, Avocetien C, Zaongo D, Colas JM, Peabody JO, Rochat CH. Impact of a program of physiotherapy and health education on the outcome of obstetric fistula surgery. Int J Gynecol Obstet 2014;124(1):77–80. [19] de Bernis L. Obstetric fistula: guiding principles for clinical management and programme development, a new WHO guideline. Int J Gynecol Obstet 2007;99(Suppl. 1): S117–21. [20] International Federation of Gynecology and Obstetrics. Global Competency-Based Fistula Surgery Training Manual. http://www.figo.org/files/figo-corp/FIGO_Global_ Competency-Based_Fistula_Surgery_Training_Manual_0.pdf. Published June 2011. Accessed May 3, 2014. [21] HEAL Africa. Promoting Healthful Congolese Lives. http://www.healafrica.org/ fostering-health/. Updated 2013. Accessed November 15, 2013. [22] Laycock J, Jerwood D. Pelvic Floor Muscle Assessment: The PERFECT Scheme. Physiotherapy 2001;87(12):631–42. [23] World Health Organization. Everybody’s business: strengthening health systems to improve health outcomes: WHO’s framework for action. http://www.who. int/healthsystems/strategy/everybodys_business.pdf. Published 2007. Accessed November 15, 2013. [24] World Health Organization. Community-based rehabilitation guidelines. http://www. who.int/disabilities/cbr/guidelines/en/. Published 2010. Accessed November 15, 2013. [25] Kayondo M, Wasswa S, Kabakyenga J, Mukiibi N, Senkungu J, Stenson A, et al. Predictors and outcome of surgical repair of obstetric fistula at a regional referral hospital, Mbarara, western Uganda. BMC Urol 2011;11:23.
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Analysis of a pilot program to implement physical therapy for women with gynecologic fistula in the Democratic Republic of Congo Laura Keyser a,⁎, Jessica McKinney b, Chris Salmon c, Cathy Furaha d, Rogatien Kinsindja e, Nerys Benfield f a
Department of Physical Medicine and Rehabilitation, Johns Hopkins Hospital, Baltimore, MD, USA Center for Women’s Health, Marathon Physical Therapy, Newton, MA, USA Department of Industrial Engineering and Engineering Management, Western New England University, Springfield, MA, USA d Department of Obstetrics and Gynecology, HEAL Africa Hospital, Goma, Democratic Republic of Congo e Department of Obstetrics and Gynecology, Hôpital Charité Maternelle, Goma, Democratic Republic of Congo f Department of Obstetrics, Gynecology and Women’s Health, Albert Einstein College of Medicine, Bronx, NY, USA b c
a r t i c l e
i n f o
Article history: Received 14 December 2013 Received in revised form 8 May 2014 Accepted 20 June 2014 Keywords: Community-based rehabilitation Global health Gynecologic fistula Maternal morbidity Pelvic floor physical therapy
a b s t r a c t Objective: To describe components of a physical therapy pilot program for women with gynecologic fistula, and to report prospective data from the first 2 years of program implementation. Methods: A single-cohort observational study with repeated measures was conducted at HEAL Africa Hospital, Goma, Democratic Republic of Congo. Hospital staff received training in pelvic floor physical therapy. Guidelines for exercise, functional training, and reproductive health education were integrated into the existing program. Demographics, clinical findings, and functional outcomes were recorded. Key stakeholders were interviewed to understand the perceived strengths and limitations of the program. Results: A total of 205 women were followed up; 161 participated in physical therapy, with an average of 9.45 sessions. Of 161 women examined postoperatively, 102 (63.4%) reported no incontinence; they remained continent at discharge. Of 21 who indicated a change in level of incontinence during postoperative physical therapy, 15 (71.4%) improved. The program was feasible and well received by staff and patients. Conclusion: Pelvic floor physical therapy could have significant results in women with gynecologic fistula, may be an important adjunctive treatment in comprehensive fistula care, and warrants further investigation. © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction Gynecologic fistula is a devastating injury associated primarily with childbirth complications, resulting in an abnormal connection between the genital tract and the urinary or intestinal tracts, leading to the uncontrolled passage of urine and/or feces [1]. It is estimated that 3.5 million women and girls worldwide are living with untreated gynecologic fistula and that 50 000–130 000 new cases arise annually [2]. The most common cause of gynecologic fistula is obstructed labor. Delays, inefficiencies, and inequities in maternal health care contribute to a labor experience that may last for several days, during which time pressure of the presenting fetal part (typically the skull) on the soft tissue of the maternal reproductive tract leads to profound tissue damage, creating the fistula [2,3]. Iatrogenic and traumatic causes are less prevalent, being responsible for 17%–24% and 4%–6% of fistula cases, respectively [4–7]. Factors contributing to obstructed labor and gynecologic fistula are among the most extreme in the Democratic Republic of Congo (DRC), ⁎ Corresponding author at: Johns Hopkins Hospital, Dept. of Physical Medicine & Rehabilitation, Meyer 1-130, 600 N. Wolfe Street, Baltimore, MD 21287, USA. Tel.: +1 415 699 0984; fax: +1 508 285 7977. E-mail addresses: [email protected], [email protected] (L. Keyser).
a country with tolerance of sexual violence against women, persistent insecurity, a weak central government, and an insufficient health system [4–10]. The eastern region of the DRC has been affected by conflict for over two decades and lacks the infrastructure to adequately provide basic needs for the population, including access to health care for its poor and displaced population [8–10]. Women with gynecologic fistula live with a high burden of disease. They are vulnerable to myriad social and psychological effects including loss of income, loss of status in family or community, loss of self-esteem, depression, and in some cases divorce, complete social isolation, and forcible expulsion from their villages [2,11]. Comorbid physical burdens can include foot drop, joint contractures, and pain [12]. Surgery is the only cure for all but the smallest and most newly formed fistulas. Many governmental and non-governmental organizations have supported outreach, hospital-based fistula surgeries, and physician training in safe surgical techniques. Despite the success of many fistula surgeries, 16%–32% of women will continue to have incontinence even after successful fistula closure and an estimated 12%–31% will require more than one fistula repair in their lifetime [13–16]. Pelvic floor physical therapy has been demonstrated to be beneficial in treatment of incontinence and pelvic floor dysfunction; however, the
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literature exploring perioperative rehabilitation for women with gynecologic fistula is sparse [17]. One study of women with gynecologic fistula in Benin [18] indicated that pelvic floor physical therapy and health education had a positive impact on postoperative recovery, with lower rates of reported incontinence. Guidelines from WHO [19] and the International Federation of Gynecology and Obstetrics [20] include physical therapy as part of a comprehensive fistula program, yet offer little to support specific protocols or training guidelines for health professionals in the development and implementation of such services. The aim of the present study was to assess a physical therapy pilot program that was integrated into an existing fistula care program at a referral hospital in Goma, DRC, and to analyze prospective data regarding patient outcomes during the first 2 years of its implementation. 2. Materials and methods A single-cohort observational study with repeated measures was performed at the HEAL Africa Hospital, Goma, DRC. This hospital is a nonprofit, 160-bed tertiary care facility that serves a population of approximately 15 million as the primary referral center for North Kivu province. It also specializes in community education and public health. One major hospital-based program there provides medicosurgical management of gynecologic fistula, coupled with socioeconomic empowerment initiatives to assist women with fistula in postoperative community reintegration. Specialty-trained surgeons have performed 2000 fistula repairs since 2003, with an average of 300 surgeries annually during years when active conflict in the region did not limit daily hospital operations and surgeries performed during outreach missions [21]. Hospital staff requested education and training in pelvic floor physical therapy to optimize patient outcomes after repair. The resulting project was approved by the institutional review boards of the University of California San Francisco (San Francisco, CA, USA) and HEAL Africa Hospital. Participants provided verbal informed consent. Physical therapists based in the USA who had regional experience, as well as expertise in community-based rehabilitation and pelvic floor physical therapy, conducted a detailed needs assessment in March 2009 prior to launching a rehabilitation program in April 2009. Training was provided to medical staff at HEAL Africa Hospital between April 1, 2009 and August 15, 2010. An evidence-based training manual was compiled, translated into French, and distributed to two physiotherapists, the chief nurse managing postoperative fistula care, and physicians specializing in obstetrics, gynecology, and urogynecologic surgery. The manual addressed pelvic floor anatomy, physiology, and pathophysiology related to pregnancy and obstetric complications, particularly fistula and incontinence. It also included chapters on patient education, lifestyle modification, exercise prescription, and progression of functional activities, such as bed mobility, and the lifting and carrying of children or firewood. All staff working with patients with fistula attended a series of lectures. Two female physical therapists received further clinical training to perform and document a digital pelvic floor muscle assessment and to instruct patients on proper exercise techniques and functional activities. Interactive instructional sessions were developed and led jointly by nurses and physical therapists to teach patients about female reproductive anatomy, fistula, and preoperative and postoperative expectations. Patients were taught about continuation of pelvic muscle exercises after discharge, attention to body mechanics to avoid stress to the repaired tissues, access to family planning, and appropriate obstetric care for future pregnancies. Counselors were also present to provide psychological support. Box 1 provides details about the clinical pathways. Visiting clinicians from the USA remained on site to provide necessary logistical and clinical support until August 15, 2010. After this time, support was provided remotely via e-mail and during 1-month site visits in 2011, 2012, and 2013. Upon completion of physical therapy training and in collaboration with a US-based obstetrician/gynecologist and the Congolese fistula
Box 1 The clinical pathway for each patient with gynecologic fistula from hospital admission to discharge. Admission • Counselor intake o Orientation to services available o Psychosocial support • Preoperative medical examination o Characteristics of fistula o Symptoms o Comorbidities o Eligibility for surgery • Preoperative physical therapy examination and treatment o Abdominal and perineal tissue mobility and presence of scar tissue o Pain and sensitivity to palpation o Pelvic muscle strength and endurance o Level of continence o Functional mobility (ability to perform bed mobility, transfers, ambulation, squatting, lifting, and carrying loads) o Diaphragmatic breathing and pelvic muscle exercise/relaxation training • Surgical repair o Foley catheter placed for 14 days o Bed rest for 24–48 hours postsurgery • Postoperative nursing and physical therapy care—days 1–14 o Nurses mobilize patient; encourage out-of-bed activity with assistance if needed o Physical therapy in small groups or one-to-one; submaximal pelvic floor muscle exercises with the catheter still in place • Postoperative physical therapy examination and treatment— days 15+ o Repeat physical therapy assessment o Exercise/functional activity progression • Pelvic floor muscle exercises; goal of 10 repetitions, 10-second hold, 10-second relaxation Discharge • Coordinated breathing, abdominal, and pelvic muscle exercise progression while supine, on all fours, or standing; functional tasks • Bowel and bladder training, as needed: timed voiding, double or triple voiding, urge response, control, and suppression; lifestyle modifications (adequate water intake, avoidance of caffeine) • Interactive group session with nurse, physiotherapist, and counselor o Female reproductive anatomy; definition and causes of fistula; dispelling myths surrounding reproduction, childbirth, and fistula; pregnancy model for demonstration o Review of pelvic floor physical therapy exercises o Family planning education
team, a patient documentation form and corresponding database were created. Demographic and clinical information was collected, including information on medicosurgical treatment and physical therapy participation. Physical therapy outcome measures included manual pelvic floor muscle assessment as described by Laycock and Jerwood [22], which has demonstrated good validity for measuring strength (r = 0.786; P b 0.001) and endurance (r = 0.549; P b 0.001) when compared with perineometric evaluation, and high interexaminer and
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test–retest reliability. Level of continence was assessed before and after the intervention via self-report and was graded using the Addis Ababa Fistula Hospital Incontinence Scale. These measures are summarized in Box 2. Data were entered into an Epi-Info database (Centers for Disease Control and Prevention, Atlanta, GA, USA) between May 21, 2010 and April 23, 2012, and descriptive statistics were generated using Microsoft Excel (Microsoft Corporation, Redmond, WA, USA). Interviews with key stakeholders were conducted between June 12 and 28, 2013 to determine providers’ perceptions on the program’s success and limitations. Interview transcripts were then evaluated for themes. 3. Results A total of 205 patient charts were entered into the database. The mean age was 31 years (range 5–69) and nearly three-quarters of patients were illiterate (Table 1). Of 197 women for whom data on parity were available, 75 (38.1%) were primiparous. More than one-quarter of women had experienced sexual violence (Table 1). Most patients presented with vesicovaginal fistula; a smaller proportion had rectovaginal fistula or combined vesicovaginal and rectovaginal fistula (Table 2). More than one-fifth indicated that they had undergone fistula surgery previously (Table 2). The average length of time from development of fistula to treatment at HEAL Africa Hospital was 46 months (range 0–600); 65 (45.1%) of 144 women waited less than 1 year to seek treatment. Most fistulas resulted from obstetric complications, with the other fistulas resulting from trauma and iatrogenic causes (Table 2). Of the 205 patients, four-fifths cited urinary incontinence as a primary symptom and almost one-third described amenorrhea (Table 2). Although all patients were to receive preoperative physical therapy, in practice, physical therapy was only reliably integrated into postoperative care, formally commencing approximately 14 days after surgery with an internal pelvic muscle examination after the catheter was removed. Physical therapy records were available for 161 patients who received an initial postoperative physical therapy examination; a discharge evaluation was completed for 142 women. Patients participated
Box 2 Physical therapy outcome measurements. Strength: Modified Oxford Grading Scheme
Endurance Repetitions
Fast contractions
Addis Ababa Fistula Hospital Incontinence Scale [22]
0 Nil 1 Flicker 2 Weak 3 Moderate 4 Good 5 Strong Length of time contraction is sustained until the muscle fatigues Number of contractions performed at initial strength grade and endurance measured Number of 1-second maximal contractions performed in rapid succession 1 Cured; no incontinence 2 Incontinent with cough, strain, exertion 3 Incontinent while walking 4 Incontinent while walking, sitting, and/or lying, but voiding some urine 5 Incontinent while walking, sitting, and/or lying, but not voiding urine
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Table 1 Patient demographics and obstetric information relevant to fistula care at HEAL Africa Hospital.a Patient characteristics
Values
Age, y (n = 187) Height, cm (n = 85) Weight, kg (n = 147) Gravidity (n = 197) Parity (n = 197) Age at 1st delivery, y (n = 158) Education (n = 192) Illiterate Primary school Secondary school Marital status (n = 182) Single Married Widowed Divorced History of sexual violence (n = 184) Yes No
31 (5–69) 155 (140–190) 52 (16–76) 3.83 (0–13.00) 3.46 (0–12.00) 18 (12–43)
a
142 (74.0) 31 (16.1) 19 (9.9) 21 (11.5) 88 (48.4) 53 (29.1) 20 (11.0) 53 (28.8) 131 (71.2)
Values are given as mean (range) or number (percentage).
in an average of 9.45 postoperative sessions, with 128 (79.5%) having 7–14 days of therapy. Medical complexity (including age), technological issues that suspended data entry, service interruption due to insecurity and active armed conflict, and premature self-discharge are among the reasons for incomplete records and/or lack of participation in physical therapy. Fig. 1 illustrates postoperative and discharge values for physical therapy measures of strength and endurance. There were modest changes in strength and endurance of the pelvic floor muscles from the initial visit to discharge. Further investigation of the patients who demonstrated a change in one or more physical therapy outcome measures revealed some differences. A difference in manual muscle test grade from postsurgery to discharge was recorded for 25 (17.6%) of the 142 women who completed a discharge evaluation. Of those, 20 (80.0%) increased by one muscle grade, 2 (8.0%) by two muscle grades, and 3 (12.0%) decreased by one muscle grade. With regard to endurance, 74 (52.1%) women exhibited a difference, of whom 66 (89.2%) were able to hold a contraction for longer and 8 (10.8%) for a shorter period, with a range of –3 to +5 seconds difference. The number of repetitions of pelvic floor muscle contractions increased for
Table 2 Physician-reported preoperative examination findings for patients presenting with gynecologic fistula.a Characteristics of fistula Type (n = 170) VVF RVF Combined Other Cause (n = 186) Obstetric Traumatic Iatrogenic Time from onset to treatment, mo Primary symptoms (n = 205) Urinary incontinence Fecal incontinence Amenorrhea Pelvic pain Previous fistula surgery (n = 170) Fistula size, mm Abbreviations: RVF, rectovaginal fistula; VVF, vesicovaginal fistula. a Values are given as number (percentage) or mean (range).
Values 147 (86.5) 10 (5.9) 10 (5.9) 3 (1.8) 171 (91.9) 5 (2.7) 10 (5.4) 46 (0–600) 164 (80.0) 4 (2.0) 63 (30.7) 3 (1.5) 38 (22.4) 25 (1–120)
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Fig. 1. Results of the physical therapy examination of pelvic floor muscle strength from 14 days postsurgery to discharge. Mean scores are indicated for each measure.
129 (90.8%) women, with an average improvement of 3.1 repetitions (range 0–7). A change in the number of fast contractions of the pelvic floor muscles was detected in 35 (24.6%) women, of whom 31 (88.6%) showed an increase and 4 (11.4%) a decrease, with a range of –5 to + 6 change in contractions. Most women (102 [63.4%]) examined postoperatively scored 1 on the incontinence scale used, meaning they had no incontinence after surgical repair of the fistula; they remained continent at discharge from the hospital. Of 21 women who indicated a change in reported level of continence during the period of physical therapy, 15 (71.4%) improved and 6 (28.6%) worsened. The six patients who reported worsening incontinence all had an open fistula on postoperative examination. The expansion of HEAL Africa Hospital’s fistula program, including the addition of a physical therapy component, was well received by staff and patients. Immediately upon inception of the program, patients reported great value in both individual and group sessions, noting dramatically enhanced understanding of reproductive anatomy, pregnancy, and the relevance of lifestyle change and continued exercise after discharge. During interviews conducted in June 2013, physicians, nurses, and physical therapists involved in the trainings reported learning new information about pelvic floor muscle function and sources of dysfunction, and indicated that the information learned was helpful to their patients. Physicians reported that they regularly referred patients to physical therapy, and reflected positively on having a treatment option to address residual incontinence postoperatively.
4. Discussion The hospital and community-based rehabilitation program integrated at HEAL Africa Hospital aimed to address the pelvic health needs of women with fistula. The present study showed some improvements in pelvic floor functional capacity from even a brief exposure to pelvic floor physical therapy. The findings suggest that significant results could be obtained by addressing impairments common among this population. The program was feasible and well received by staff and patients. Despite having little background in pelvic floor physical therapy, the physical therapists at HEAL Africa Hospital learned to perform an internal pelvic muscle examination and record measurements related to strength and endurance. A positive trend for these outcome measures indicates that pelvic floor physical therapy may influence pelvic muscle strength and function for patients with gynecologic fistula. Functional outcomes (measured via level of incontinence) improved for 71.4% of patients who participated in physical therapy and demonstrated a change in status during this 2–3-week period. Although the program was well received by hospital staff, they also identified several limitations of the program. Both physicians and physical therapists reported needing more support in 2011–13 from the US clinician team in the form of continuing education and clinical skills training to improve capacity to diagnose and treat this patient population. Physicians cited administrative changes and staff turnover within
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the hospital and ongoing conflict and insecurity in the region as contributors to incomplete or missing patient charts and lapses in data entry. Both physicians and physical therapists expressed a desire to follow patients up for at least 6 months postoperatively to more accurately assess outcomes and to continue to provide pelvic health and family planning interventions. They cited funding as a major barrier to program continuation and success. Myriad influences on patient outcomes confound the data, and there are limitations of a single cohort observational study with repeated measures. Without a control group for comparison, it is not possible to know that it is definitively the physical therapy that has led to these improvements, as opposed to typical postoperative healing. As with many fistula care programs, long-term follow-up was not possible in the present study, and it is therefore not possible to report whether women continued to benefit from the program and how their levels of continence may have been affected over time. Most literature to support the use of pelvic floor physical therapy in treating urinary incontinence reports a treatment effect after 8–12 weeks [17]. Due to ongoing conflict and poor infrastructure in the region, there was no access to patients once they were discharged. This lack of long-term follow-up also means it is not possible to determine if a physical therapy program that emphasizes integrated pelvic floor function can protect the integrity of the original fistula repair and hence stave off the reported 11%–27% recurrence rate [15]. However, the positive data trend, along with patient and provider feedback, indicates that the addition of a physical therapy component to a comprehensive fistula care program benefits patients and may positively influence outcomes without adverse effects. Commitment of local providers and availability of visiting expert clinicians to provide direct on-site training were key to the program’s success. The hospital’s existing fistula program and experienced providers formed the framework that allowed physical therapy education and services to be integrated at various levels of care. The principles of community-based rehabilitation and health-systems strengthening support a two-fold approach: (1) enhance clinical skills by providing specialized pelvic floor physical therapy training to clinicians, and (2) change health behaviors and long-term patient outcomes through community-level education [23,24]. Future studies will evaluate treatment interventions and longerterm outcomes utilizing strong objective measures and appropriate sample sizes to facilitate statistical analysis. It is hoped that they will also assess the feasibility and utility of physical therapy to specifically address the problems of residual incontinence, recurrent gynecologic fistula, pelvic pain, and excessive vaginal scar tissue, which has been negatively associated with fistula surgery outcomes [25]. In conclusion, the present study describes the implementation and evaluation of an integrated program of physical therapy for women after surgical repair of gynecologic fistula. The results indicate that pelvic physical therapy may be an important adjunctive treatment for the comprehensive care of women with fistula and warrants further investigation. The model presented holds promise as a replicable program for other institutions that perform fistula repair, integrating the unique skill set of physical therapists into the optimal treatment of women with and recovering from gynecologic fistula. Acknowledgments This program was funded in part by Global Strategies and through a Tides Foundation grant awarded to HEAL Africa USA.
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