Effect of Midwife-Led Pelvic Floor Muscle Training on Prolapse Symptoms and Quality of Life in Women with Pelvic Organ Prolapse in Ethiopia: A Cluster-Randomized Controlled Trial
Authors: Siyoum Melese , Nardos Rahel , Sirak Biniyam , Spitznagle Theresa , Teklesilasie Wondwosen , Astatkie Ayalew 
Published: August 2024

Background

Pelvic organ prolapse (POP) is a common condition that can significantly impact a woman’s quality of life. Pelvic floor muscle training (PFMT) is recommended as a first-line conservative treatment for prolapse, but evidence on its effectiveness from low-resource settings is limited. This study aimed to assess the effect of midwife-led pelvic floor muscle training on prolapse symptoms and health-related quality of life (HRQoL) among women with mild to moderate pelvic organ prolapse in Ethiopia.

Methods and Findings

A community-based, parallel-groups, two-arm cluster-randomized controlled trial was conducted in Dale and Wonsho districts of Sidama Region, Ethiopia. Women with symptomatic POP stages I-III were randomized by cluster to receive either midwife-led PFMT plus lifestyle counseling (intervention group) or lifestyle counseling alone (control group). The participants and counsellors knew what the women were receiving but they were not aware of the other group. The outcome assessors, who collected data at the end of intervention, were blinded to the participants’ treatment allocation. The primary outcomes were changes in prolapse symptom score (POP-SS) and prolapse quality of life (P-QoL). Mixed-effects generalized linear model was used to determine the effect of PFMT on prolapse symptoms and P-QoL at 99% confidence level. Adjusted β coefficients were used as effect measures. The level of significance was adjusted for multiple comparisons.

A total of 187 women were randomized to intervention (n=86) from 4 clusters and control (n=101) arms from another four clusters. At sixth months, the intervention group showed significantly greater improvements both in prolapse symptoms and P-QoL. The mean change difference in POP-SS was −4.11 (99% CI [−5.38, −2.83]; p < 0.001). Similarly, the mean change difference was: −8.86 (99% CI [−13.84, −3.89]; p<0.001) in physical domain of P-QoL; −11.18 (99% CI [−15.03, −7.32]; p<0.001) in psychological domain of P-QoL, and −9.01 (99% CI [−, −5.54]; p <0.001) in personal relationship domain of P-QoL. A significantly higher proportion (83.72%) of women in the intervention group perceived their condition as “better” after the intervention as compared to 41.58% in the control group. Women with earlier stages of prolapse (stage I and II) experienced higher benefits compared to those in stage III.

Conclusions

A midwife-led PFMT combined with lifestyle counseling significantly improves prolapse symptoms and quality of life in mild to moderate POP. This strategy can be integrated into the existing maternal and reproductive health programs to address POP in low-income settings where access to trained specialist is limited.

Trial registration

Pan African Clinical Trial Registry (PACTR202302505126575).

Author Summary

Why Was This Study Done?

Pelvic organ prolapse (POP) is a prevalent condition that can severely impact women’s quality of life, particularly in low-resource settings where access to specialized care is limited.

Prior to this research, there was limited evidence regarding the effectiveness of pelvic floor muscle training (PFMT) as a conservative treatment option for POP in such contexts, highlighting the need for effective interventions.

What Did the Researchers Do and Find?

The study utilized a cluster-randomized controlled trial design involving eight clusters (four clusters in each arm) and a total of 187 women, all drawn from these clusters, with mild to moderate pelvic organ prolapse (POP) in Sidama region, Ethiopia. The intervention group received midwife-led pelvic floor muscle training (PFMT) combined with lifestyle counseling, while the other group received only lifestyle counseling.

The key findings from the study showed that women who participated in the midwife-led pelvic floor muscle training (PFMT) combined with lifestyle counseling experienced a significant reduction in their pelvic organ prolapse (POP) symptoms. Specifically, there was an average decrease of 4.11 points in their symptom scores, which indicates a notable improvement in how they felt. Additionally, the women reported substantial enhancements in various aspects of their quality of life, meaning they felt better overall and were able to engage more fully in daily activities

What Do These Findings Mean?

The research demonstrates that midwife-led PFMT can serve as an effective first-line treatment for POP, improving symptoms and quality of life in low-resource settings.

However, limitations include reliance on self-reported data, and a relatively short follow-up period may limit generalizability of the findings.