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Osteopathische Behandlung von Frauen mit Harninkontinenz nach Verletzung des Perineums unter der Entbindung. Eine randomisierte kontrollierte Studie.
(Osteopathic treatment of women suffering from urinary incontinence as a result of an injury to the perineum during delivery. A randomized controlled trial)

Journal: Unpublished D.O. thesis Akademie für Osteopathie, Date: 2007/10, , type of study: randomized controlled trial

Full text    (https://www.osteopathie-akademie.de/studien-thesen)

Keywords:

perineum [2]
incontinence [31]
urinary tract symptom [12]
woman [19]
female [379]
injury [85]
osteopathic manipulative treatment [2973]
OMT [2951]
randomized controlled trial [710]

Abstract:

Objective: The main objective of this study is to evaluate whether osteopathic treatment in addition to the standard therapy of “pelvic floor muscle training” can significantly improve the overall quality of life of women suffering from urinary incontinence as a result of an injury to the perineum during delivery. Design: Randomised controlled study. Setting: The study was carried out by two female osteopaths, trained at the Still Academy, in their practices in Münster. The patients were referred by various gynaecologists and midwifes in agreement with the parameters of the study. Patients: 60 women (average age 37.5 ± 4.5 years) diagnosed by their gynaecologists as suffering from urinary incontinence (stress or urge urinary incontinence) took part in the study. A further criterion for the participation in this study was an injury of the perineum during vaginal delivery (either episiotomy or perineal rupture). By means of external randomisation 30 women were assigned to the intervention group, 30 women to the control group. Two patients of the intervention group dropped out during the time of the study. Intervention: The patients of the intervention group received 4 osteopathic treatments in intervals of 3 weeks in addition to the pelvic floor muscle training provided by a female physiotherapist with exercises to be carried out at home regularly for the following intervention time of 12 weeks. The patients of the control group received the same introduction of pelvic floor muscle training as the intervention group; they were also asked to carry out the exercises at home regularly for the following 12 weeks. The osteopathic dysfunctions in the visceral, parietal and cranio-sacral systems were recorded on the day of treatment in accordance with the individual diagnoses of the patients and were treated based on osteopathic principles. Objective parameters: The primary objective, i.e. ”the quality of life of women suffering from urinary incontinence” was measured by means of the King's Health Questionnaire (KHQ). The secondary objective, i.e. ”the number of daily toilet visits as well as the amount of involuntary loss of urine per day” was recorded in a micturition diary. Results: The total score of the KHQ could only be measured for about 40 patients because of missing values. In the intervention group the symptom-specific quality of life had significantly improved by the end of the treatment, from 34% to 19% which constitutes an improvement of 44% (p< 0.0005; 95% CI=8.6 to 21.4). The improvement in the control group was less evident with 31% (p=0.011; 95% CI=2.6 to 16.6). The direct comparison of both groups did not show any statistic significance in favour of one group (p=0.24; 95%CI=-3.7 to 14.6). Only one of the 9 single items of the KHQ, i.e. ”Limitation of daily activities”, showed a significant difference (p = 0.007, 95% CI=3.1 to 25.8). To allow evaluation of the total number of 60 patients the missing values were filled in, first by using an average value of the item in question, then by using the worst possible value. The total score of the KHQ then showed statistic significance in favour of the group receiving osteopathic treatment. Regarding the secondary objective, ”number of daily toilet visits”, there was no difference to be noted in either of the groups during the time of the study. The amount of “involuntary loss of urine “ was reduced more evidently in the group receiving osteopathic treatment as compared to the control group (80% versus 71%). Conclusion: Four osteopathic treatments in intervals of 3 weeks in addition to pelvic floor muscle training under initial supervision of a physiotherapist had a clinically relevant influence on the symptom-specific quality of life of women with urinary incontinence following an injury of the perineum. Osteopathy seems to be a suitable therapeutic method for the treatment of women with urinary incontinence following perineal injury.

Abstract original language:
Studienziel: Ziel dieser Studie ist die Evaluation der Effektivität der osteopathischen Behandlung zusätzlich zur Standardtherapie Beckenbodengymnastik in Hinsicht auf die symptomspezifische Lebensqualität von Frauen mit Harninkontinenz, die unter einer Entbindung eine Verletzung des Perineums erlitten haben. Studiendesign: Randomisierte kontrollierte Studie. Setting: Die Studie wurde von zwei an der Still Academy ausgebildeten Osteopathinnen in ihren Praxen in Münster durchgeführt. Die Rekrutierung der Patientinnen erfolgte über Gynäkologinnen/Gynäkologen und Hebammen. Patienten: An der Studie nahmen 60 Patientinnen (Alter im Mittel 37,5 ± 4,5 Jahre) mit ärztlich bestätigter Diagnose Harninkontinenz teil. Zusätzlich bestand die Vorraussetzung, dass bei mindestens einer vaginalen Entbindung eine Episiotomie durchgeführt worden war oder ein Dammriss vorlag. Durch externe Randomisierung wurden je 30 Patientinnen der Interventionsgruppe und der Kontrollgruppe zugeteilt. Zwei Patienten der Interventionsgruppe schieden im Verlauf der Studie aus. Intervention: Die Patientinnen der Interventionsgruppe erhielten 4 osteopathische Behandlungen im Abstand von jeweils 3 Wochen. In beiden Gruppen fand während des 9-wöchigen Interventions-zeitraums die Anleitung zur Beckenbodengymnastik statt, die zusätzlich selbständig durchgeführt werden sollte. Die osteopathischen Dysfunktionen im viszeralen, parietalen und kranialen System wurden entsprechend dem individuellen Befund des Patienten am Behandlungstag erfasst und nach den Prinzipien der Osteopathie behandelt. Zielparameter: Der primäre Zielparameter war die symptomspezifische Lebensqualität bei Harninkontinenz, ermittelt über den King´s Health Questionnaire (KHQ). Als sekundäre Zielparameter wurden Anzahl der täglichen Toilettengänge und die unfreiwilligen Urinverluste mittels Miktionstagebuch erfasst. Ergebnisse: Der Gesamtscore des KHQ konnte nur bei ca. 40 Patientinnen aufgrund fehlender Werte berechnet werden. In der Interventionsgruppe verbesserte sich die symptomspezifische Lebensqualität bis zum Ende der Behandlungen signifikant von 34% auf 19%, was einer Verbesserung von 44% entspricht.


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