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Background: The effectiveness of laparoscopic ventral mesh rectopexy (LVMR) in patients with defecatory disorders secondary to internal rectal prolapse is poorly evidenced. A UK-based multicenter randomized controlled trial was designed to determine the clinical efficacy of LVMR compared to controls at medium-term follow-up. Methods: The randomized controlled trial was conducted from March 1, 2015 TO January 31, 2019. A stepped-wedge RCT design permitted observer-masked data comparisons between patients awaiting LVMR (controls) with those who had undergone surgery. Adult participants with radiologically confirmed IRP refractory to conservative treatment were randomized to three arms with different delays before surgery. Efficacy outcome data were collected at equally stepped time points (12, 24, 36, 48, 60, and 72 weeks). Clinical efficacy of LVMR compared to controls was defined as ≥ 1.0-point reduction in Patient Assessment of Constipation-Quality of Life and/or Symptoms (PAC-QOL and/or PAC-SYM) scores at 24 weeks. Secondary outcome measures included 14-day diary data, the Generalized Anxiety Disorder scale (GAD-7), the Patient Health Questionnaire-9 (PHQ-9), St Marks incontinence score, the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), the chronic constipation Behavioral Response to Illness Questionnaire (CC-BRQ), and the Brief Illness Perception Questionnaire (BIPQ). Results: Of a calculated sample size of 114, only 28 patients (100% female) were randomized from 6 institutions (due mainly to national pause on mesh-related surgery). Nine were assigned to the T0 arm, 10 to T12, and 9 to T24. There were no substantial differences in baseline characteristics between the three arms. Compared to baseline, significant reduction (improvement) in PAC-QOL and PAC-SYM scores were observed at 24 weeks post-surgery (– 1.09 [95% CI – 1.76, – 0.41], p = 0.0019, and – 0.92 [– 1.52, – 0.32], p = 0.0029, respectively) in the 19 patients available for analysis (9 were excluded for dropout [n = 2] or missing primary outcome [n = 7]). There was a clinically significant long-term reduction in PAC-QOL scores (− 1.38 [− 2.94, 0.19], p = 0.0840 at 72 weeks). Statistically significant improvements in PAC-SYM scores persisted to 72 weeks (− 1.51 [− 2.87, − 0.16], p = 0.0289). Compared to baseline, no differences were found in secondary outcomes, except for significant improvements at 24 and 48 weeks on CC-BRQ avoidance behavior (− 14.3 [95% CI − 23.3, − 5.4], and − 0.92 [− 1.52, − 0.32], respectively), CC-BRQ safety behavior (− 13.7 [95% CI − 20.5, − 7.0], and − 13.0 [− 19.8, − 6.1], respectively), and BIPQ negative perceptions (− 16.3 [95% CI − 23.5, − 9.0], and − 10.5 [− 17.9, − 3.2], respectively). Conclusions: With the caveat of under-powering due to poor recruitment, the study presents the first randomized trial evidence of short-term benefit of LVMR for internal rectal prolapse. Trial registration: ISRCTN Registry (ISRCTN11747152). [ABSTRACT FROM AUTHOR]

In a randomized controlled trial, we tested the efficacy of Baby Triple P in a community sample of first-time parent couples. The intervention was developed to promote better mental health, a positive couple relationship, positive parenting, and a better parent-infant relationship. One hundred and fifty six couples were randomly allocated to intervention (n = 78) or care as usual (n = 78) conditions. The intervention was delivered in four antenatal face-to-face group sessions followed by four early postnatal individual telephone sessions. Couples completed self-report assessments at baseline, immediately postintervention and at 12 and 24 months. The study had one primary (the Depression, Anxiety and Stress Scale) and 11 secondary outcomes. Over half of the intervention and care as usual participants remained in the study for the full 24 months. Intention to treat analysis of the full sample yielded positive results in some mental health domains for mothers and fathers, but this was not evident when follow up sensitivity analysis was conducted on a subsample of the data. There was limited support for the intervention in relation to secondary outcomes such as the couple relationship, social support and parenting. However, the parent couples were positive about the intervention and described it as providing the support that they wanted. This trial provides some evidence in support of Baby Triple P as an early intervention for new parent couples. High levels of satisfaction with the intervention are promising, especially in relation to the engagement of fathers. Trial Registration: ISRCTN31955576 Highlights: This randomized controlled trial provides some evidence that the mental health of new parents is amenable to intervention. This randomized controlled trial provides some evidence in support of Baby Triple P as an early intervention. Evidence from this study demonstrates that engagement and retention of fathers is possible and fathers value involvement. Initial engagement is a critical point in the delivery of early interventions; couples who are engaged are more likely to complete the intervention. [ABSTRACT FROM AUTHOR]